Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity
Official Title
Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients With Rare Genetic Disorders of Obesity
Acronym
Not provided
Organization
Rhythm Pharmaceuticals, Inc.INDUSTRY
Status Module
Record Verification Date
Jul 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 10, 2017Actual
Primary Completion Date
Mar 1, 2022Actual
Completion Date
Mar 1, 2022Actual
First Submitted Date
Jan 3, 2017
First Submission Date that Met QC Criteria
Jan 4, 2017
First Posted Date
Jan 6, 2017Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 25, 2023
Results First Submitted that Met QC Criteria
Jul 25, 2023
Results First Posted Date
Aug 18, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 25, 2023
Last Update Posted Date
Aug 18, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Rhythm Pharmaceuticals, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of the study was to determine the effect of setmelanotide (RM-493) on weight, hunger assessments, and other factors in participants with rare genetic disorders of obesity.
Detailed Description
Not provided
Conditions Module
Conditions
Genetic Obesity
Obesity
Obesity Due to Melanocortin 4 Receptor Deficiency
Keywords
Pro-opiomelanocortin (POMC) deficiency obesity
LepR deficiency obesity
Smith-Magenis Syndrome
MC4R deficiency obesity
SRC1 deficiency obesity
SH2B1 deficiency obesity
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
213Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
16p11.2 Cohort
Experimental
Participants with chromosomal rearrangement of the p11.2 region of chromosome 16 (16p11.2) locus causing obesity received setmelanotide once daily (QD) via subcutaneous (SC) injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Drug: Setmelanotide
AS Cohort
Experimental
Participants with Alström syndrome (AS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Drug: Setmelanotide
BBS Cohort
Experimental
Participants with Bardet-Biedl syndrome (BBS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Setmelanotide
Drug
RM-493 QD SC injection
16p11.2 Cohort
AS Cohort
BBS Cohort
MC4R Cohort
POMC/PCSK1/LEPR Composite Heterozygous Cohort
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment
Baseline to Month 3
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE (also referred to as an adverse experience) could be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TEAEs were defined as AEs reported after dosing on Day 1.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants with the following genotypes and/or clinical assessment:
POMC/PCSK1/LEPR heterozygous - not currently enrolling new participants
POMC/PCSK1/LEPR compound heterozygous (two different mutations in gene) or homozygous deficiency obesity
POMC/PCSK1/LEPR composite heterozygous (two or more mutations in two or more genes) deficiency obesity
SMS
SH2B1 deficiency obesity
Chromosomal rearrangement of the 16p11.2 locus causing obesity
Carboxypeptidase E (CPE) compound heterozygous or homozygous deficiency obesity
Leptin deficiency obesity with loss of response to metreleptin
SRC1 deficiency obesity
MC4R deficiency obesity
Age 6 years and above
Obese, defined as Body Mass Index (BMI) ≥ 30 kilogram per meter square (kg/m^2) for participants ≥16 years of age or BMI≥ 95th percentile for age and gender for participants 6 up to 16 years of age.
Participant and/or parent or guardian is able to understand and comply with the requirements of the study and is able to understand and sign the written informed consent/assent
Female participants of childbearing potential must be confirmed non-pregnant, and agree to use contraception as outlined in the protocol.
Male participants with female partners of childbearing potential must agree to a double barrier method if they become sexually active during the study. Male participants must not donate sperm during and for 90 days following their participation in the study.
Key Exclusion Criteria:
Recent intensive (within 2 months) diet and/or exercise regimen with or without the use of weight loss agents that has resulted in > 2% weight loss.
Use of any medication that is approved to treat obesity within three months of first dose of study drug (e.g., orlistat, lorcaserin, phentermine-topiramate, naltrexone-bupropion).
Gastric bypass surgery within the previous six months or any prior gastric bypass surgery resulting in >10% weight loss durably maintained
Diagnosis of schizophrenia, bipolar disorder, personality disorder, major depressive disorder, or other psychiatric disorder(s)
Suicidal ideation, attempt or behavior
Clinically significant pulmonary, cardiac, or oncologic disease
hemoglobin A1c (HbA1c) > 9.0% at Screening
History of significant liver disease
Glomerular filtration rate (GFR) < 30 milliliter/minute (mL/min) at Screening.
History or close family history of melanoma or participant history of oculocutaneous albinism
Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions.
Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing.
Participants previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide.
Inability to comply with QD injection regimen.
Females who are breastfeeding or nursing.
Other protocol defined Inclusion/Exclusion criteria may apply.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
6 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
David Meeker, MD
Rhythm Pharmaceuticals, Inc.
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Synexus Clinical Research US, Inc. - Simon Williamson Clinic, PC
Ervin C, Norcross L, Mallya UG, Fehnel S, Mittleman RS, Webster M, Haqq AM, Haws RM. Interview-Based Patient- and Caregiver-Reported Experiences of Hunger and Improved Quality of Life with Setmelanotide Treatment in Bardet-Biedl Syndrome. Adv Ther. 2023 May;40(5):2394-2411. doi: 10.1007/s12325-023-02443-y. Epub 2023 Mar 24.
Of the 218 participants screened, 213 participants were enrolled in the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
16p11.2 Cohort
Participants with chromosomal rearrangement of the p11.2 region of chromosome 16 (16p11.2) locus causing obesity received setmelanotide once daily (QD) via subcutaneous (SC) injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 20, 2020
Jul 25, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Setmelanotide
MC4R Cohort
Experimental
Participants with melanocortin-4 receptor (MC4R) deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Drug: Setmelanotide
POMC/PCSK1/LEPR Heterozygous Cohort
Experimental
Participants with pro-opiomelanocortin (POMC)/proprotein convertase subtilisin/kexin type 1 (PCSK1)/leptin receptor (LEPR) heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Drug: Setmelanotide
POMC/PCSK1/LEPR Composite Heterozygous Cohort
Experimental
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Drug: Setmelanotide
POMC/PCSK1/LEPR Compound Heterozygous Cohort
Experimental
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Drug: Setmelanotide
SH2B1 Cohort
Experimental
Participants with steroid receptor coactivator (SRC) homology 2B adapter protein 1 (SH2B1) haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Drug: Setmelanotide
SMS Cohort
Experimental
Participants with Smith-Magenis Syndrome (SMS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Drug: Setmelanotide
SRC1 Cohort
Experimental
Participants with steroid receptor coactivator 1 (SRC1) mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Drug: Setmelanotide
POMC/PCSK1/LEPR Compound Heterozygous Cohort
POMC/PCSK1/LEPR Heterozygous Cohort
SH2B1 Cohort
SMS Cohort
SRC1 Cohort
RM-493
From first dose up to Month 16
Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment
Baseline, Month 3
Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment
Baseline, Month 3
Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
The mean change in daily hunger questionnaire scores for participants ≥ 12 years of age with obesity in treatment with setmelanotide was evaluated. On the Daily Hunger Questionnaire, each of the 3 items (average hunger in the last 24 hours, most/worst hunger in the last 24 hours, and morning hunger) was assessed daily and scored separately using a numeric rating score for each from 0 to 10, with 0 = not hungry at all and 10 = hungriest possible.
Baseline, Month 3
Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
The mean change in daily hunger questionnaire scores for participants < 12 years of age with obesity in treatment with setmelanotide was evaluated. Hunger was assessed daily using a Daily Hunger Questionnaire with a pictorial (smiley face) version of the Likert rating scale with scores ranged from 0 to 4, with 0 = not hungry at all and 4 = hungriest possible.
Baseline, Month 3
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
For participants ≥ 12 years of age, the following question was asked using the Global Hunger Questionnaire: Overall, how would you rate the hunger you experience now? Possible responses were: No hunger; Mild hunger; Moderate hunger; Severe hunger; and Not answered.
Baseline, Month 3
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
For participants < 12 years of age, the following question was asked to parents or caregivers of participants using the Global Hunger Questionnaire: How hungry is your child acting now? Possible responses were: Not hungry at all; A little hungry; Moderately hungry; Extremely hungry; and Not answered.
Baseline, Month 3
Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment
Waist circumference (cm) was measured according to the National Heart, Lung, and Blood Institute (NHLBI) criteria. All measurements were single measures. Waist circumference was measured when participants were in fasting condition and at approximately the same time at each visit.
Baseline, Month 3
Synexus Clinical Research US, Inc. - Phoenix Southeast
Chandler
Arizona
85224
United States
Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
Mesa
Arizona
85206
United States
Honor Health Research Institute
Scottsdale
Arizona
85258
United States
Axis Clinical Trials-Downtown
Los Angeles
California
90017
United States
Axis Clinical Trials Headquarters
Los Angeles
California
90036
United States
San Diego Wake Research
San Diego
California
92108
United States
Anschutz Health and Wellness Center University of Colorado Anschutz Medical Campus
Aurora
Colorado
80045
United States
Division of Endocrinology and Diabetes Children's National Hospital
Washington D.C.
District of Columbia
20010
United States
University of Florida College of Medicine
Gainesville
Florida
32610
United States
AXIS South Florida Clinical Trials
Hialeah
Florida
33016
United States
Florida Hospital
Orlando
Florida
32804
United States
Synexus Clinical Research US, Inc. - St. Petersburg
Pinellas Park
Florida
33781
United States
Synexus Clinical Research US, Inc. - Chicago
Chicago
Illinois
60602
United States
Maine Medical Partners
Portland
Maine
04102
United States
NIH Hatfield Clinical Research Center
Bethesda
Maryland
20892
United States
Baystate Medical Center
Springfield
Massachusetts
01107
United States
University of Michigan Medicine
Ann Arbor
Michigan
48105
United States
Precision Medicine for Obesity Research: Gastroenterology & Hepatology Mayo Clinic
Rochester
Minnesota
55905
United States
Washington University St. Louis
St Louis
Missouri
63110
United States
Impact Clinical Trials
Las Vegas
Nevada
89106
United States
AXIS New York Clinical Trials
Brooklyn
New York
11201
United States
University at Buffalo
Buffalo
New York
14203
United States
AXIS Clinical Trials
New York
New York
10022
United States
Icahn School of Medicine at Mount Sinai
New York
New York
10025
United States
Columbia University
New York
New York
10032
United States
Duke University Medical Center
Durham
North Carolina
27705
United States
Wake Research Inc.
Raleigh
North Carolina
27612
United States
Synexus Clinical Research US, Inc. - Akron
Akron
Ohio
44311
United States
Synexus Clinical Research US, Inc. - Cincinnati
Cincinnati
Ohio
45236
United States
Synexus Clinical Research US, Inc. - Columbus
Columbus
Ohio
43016
United States
Obesity Institute, Geisinger Clinic
Danville
Pennsylvania
17822
United States
Childrens Hospital of Philadelphia
Philadelphia
Pennsylvania
19104
United States
Synexus Clinical Research US, Inc. - Primary Care Associates, PC
Participants with Alström syndrome (AS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
FG002
BBS Cohort
Participants with Bardet-Biedl syndrome (BBS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
FG003
MC4R Cohort
Participants with melanocortin-4 receptor (MC4R) deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
FG004
POMC/PCSK1/LEPR Heterozygous Cohort
Participants with pro-opiomelanocortin (POMC)/proprotein convertase subtilisin/kexin type 1 (PCSK1)/leptin receptor (LEPR) heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
FG005
POMC/PCSK1/LEPR Composite Heterozygous Cohort
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
FG006
POMC/PCSK1/LEPR Compound Heterozygous Cohort
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
FG007
SH2B1 Cohort
Participants with steroid receptor coactivator (SRC) homology 2B adapter protein 1 (SH2B1) haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
FG008
SMS Cohort
Participants with Smith-Magenis Syndrome (SMS) received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
FG009
SRC1 Cohort
Participants with steroid receptor coactivator 1 (SRC1) mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
FG00019 subjects
FG0014 subjects
FG00210 subjects
FG00349 subjects
FG00433 subjects
FG0055 subjects
FG00627 subjects
FG00722 subjects
FG00812 subjects
FG00932 subjects
COMPLETED
FG00019 subjects
FG0012 subjects
FG0027 subjects
FG00337 subjects
FG00422 subjects
FG0052 subjects
FG00620 subjects
FG00713 subjects
FG0089 subjects
FG00922 subjects
NOT COMPLETED
FG0000 subjects
FG0012 subjects
FG0023 subjects
FG00312 subjects
FG00411 subjects
FG0053 subjects
FG0067 subjects
FG0079 subjects
FG0083 subjects
FG00910 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0035 subjects
FG0046 subjects
FG0052 subjects
FG0063 subjects
FG0071 subjects
FG0080 subjects
FG0094 subjects
Withdrawal By Parent/Guardian
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Non-Compliance With Study Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The Full Analysis Set (FAS) included all participants who received at least 1 dose of study drug and had baseline weight data.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
16p11.2 Cohort
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
BG001
AS Cohort
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
BG002
BBS Cohort
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
BG003
MC4R Cohort
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
BG004
POMC/PCSK1/LEPR Heterozygous Cohort
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
BG005
POMC/PCSK1/LEPR Composite Heterozygous Cohort
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
BG006
POMC/PCSK1/LEPR Compound Heterozygous Cohort
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
BG007
SH2B1 Cohort
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
BG008
SMS Cohort
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
BG009
SRC1 Cohort
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00019
BG0014
BG00210
BG00349
BG00433
BG0055
BG00627
BG00722
BG00812
BG00932
BG010213
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00021.4± 14.58
BG00116.0± 3.74
BG00222.5± 14.71
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG0013
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Body Weight
Mean
Standard Deviation
kilograms (kg)
Title
Denominators
Categories
Title
Measurements
BG000113.62± 38.489
BG00187.28± 16.360
BG002
Waist Circumference
Mean
Standard Deviation
centimeters (cm)
Title
Denominators
Categories
Title
Measurements
BG000116.84± 22.179
BG001109.75± 14.523
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment
Participants in the FAS were analyzed.
Posted
Count of Participants
Participants
Baseline to Month 3
ID
Title
Description
OG000
16p11.2 Cohort
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG001
AS Cohort
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG002
BBS Cohort
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG003
MC4R Cohort
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG004
POMC/PCSK1/LEPR Heterozygous Cohort
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG005
POMC/PCSK1/LEPR Composite Heterozygous Cohort
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG006
POMC/PCSK1/LEPR Compound Heterozygous Cohort
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG007
SH2B1 Cohort
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG008
SMS Cohort
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG009
SRC1 Cohort
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Units
Counts
Participants
OG00019
OG0014
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG0006
OG0013
OG0027
OG003
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE (also referred to as an adverse experience) could be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TEAEs were defined as AEs reported after dosing on Day 1.
Safety Analysis Set included all participants who received at least 1 dose of study drug.
Posted
Count of Participants
Participants
From first dose up to Month 16
ID
Title
Description
OG000
16p11.2 Cohort
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG001
AS Cohort
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Secondary
Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment
Participants in the FAS were analyzed.
Posted
Mean
Standard Deviation
kg
Baseline, Month 3
ID
Title
Description
OG000
16p11.2 Cohort
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG001
AS Cohort
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Secondary
Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment
Participants in the FAS were analyzed.
Posted
Mean
Standard Deviation
percent change
Baseline, Month 3
ID
Title
Description
OG000
16p11.2 Cohort
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG001
AS Cohort
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Secondary
Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
The mean change in daily hunger questionnaire scores for participants ≥ 12 years of age with obesity in treatment with setmelanotide was evaluated. On the Daily Hunger Questionnaire, each of the 3 items (average hunger in the last 24 hours, most/worst hunger in the last 24 hours, and morning hunger) was assessed daily and scored separately using a numeric rating score for each from 0 to 10, with 0 = not hungry at all and 10 = hungriest possible.
Participants aged ≥ 12 years in the FAS with available data were analyzed.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Month 3
ID
Title
Description
OG000
16p11.2 Cohort
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG001
AS Cohort
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Secondary
Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
The mean change in daily hunger questionnaire scores for participants < 12 years of age with obesity in treatment with setmelanotide was evaluated. Hunger was assessed daily using a Daily Hunger Questionnaire with a pictorial (smiley face) version of the Likert rating scale with scores ranged from 0 to 4, with 0 = not hungry at all and 4 = hungriest possible.
Participants < 12 years of age in the FAS with available data were analyzed.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Month 3
ID
Title
Description
OG000
16p11.2 Cohort
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG001
AS Cohort
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Secondary
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
For participants ≥ 12 years of age, the following question was asked using the Global Hunger Questionnaire: Overall, how would you rate the hunger you experience now? Possible responses were: No hunger; Mild hunger; Moderate hunger; Severe hunger; and Not answered.
Participants ≥ 12 years of age in the FAS with available data were analyzed.
Posted
Number
participants
Baseline, Month 3
ID
Title
Description
OG000
16p11.2 Cohort
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG001
AS Cohort
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Secondary
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
For participants < 12 years of age, the following question was asked to parents or caregivers of participants using the Global Hunger Questionnaire: How hungry is your child acting now? Possible responses were: Not hungry at all; A little hungry; Moderately hungry; Extremely hungry; and Not answered.
Participants < 12 years of age in the FAS with available data were analyzed.
Posted
Number
participants
Baseline, Month 3
ID
Title
Description
OG000
16p11.2 Cohort
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG001
AS Cohort
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Secondary
Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment
Waist circumference (cm) was measured according to the National Heart, Lung, and Blood Institute (NHLBI) criteria. All measurements were single measures. Waist circumference was measured when participants were in fasting condition and at approximately the same time at each visit.
Participants in the FAS with available data were analyzed.
Posted
Mean
Standard Deviation
percent change
Baseline, Month 3
ID
Title
Description
OG000
16p11.2 Cohort
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG001
AS Cohort
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Time Frame
From first dose up to Month 16
Description
Participants in the Safety Analysis Set were analyzed.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
16p11.2 Cohort
Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
0
19
1
19
19
19
EG001
AS Cohort
Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
0
4
0
4
4
4
EG002
BBS Cohort
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
0
10
1
10
10
10
EG003
MC4R Cohort
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
1
49
1
49
48
49
EG004
POMC/PCSK1/LEPR Heterozygous Cohort
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
0
33
1
33
33
33
EG005
POMC/PCSK1/LEPR Composite Heterozygous Cohort
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
0
5
1
5
5
5
EG006
POMC/PCSK1/LEPR Compound Heterozygous Cohort
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
0
27
2
27
27
27
EG007
SH2B1 Cohort
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
0
22
0
22
21
22
EG008
SMS Cohort
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
0
12
0
12
12
12
EG009
SRC1 Cohort
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
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Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute Myocardial Infarction
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG0031 affected49 at risk
EG0041 affected33 at risk
EG0050 affected5 at risk
EG0060 affected27 at risk
EG0070 affected22 at risk
EG0080 affected12 at risk
EG0090 affected32 at risk
Diverticulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Rotavirus Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Melanocytic Naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Typical Aura Without Headache
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Skin Hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG00017 affected19 at risk
EG0013 affected4 at risk
EG0028 affected10 at risk
EG00340 affected49 at risk
EG00419 affected33 at risk
EG0053 affected5 at risk
EG00621 affected27 at risk
EG00716 affected22 at risk
EG00810 affected12 at risk
EG00923 affected32 at risk
Macule
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Lentigo
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0022 affected10 at risk
EG003
Ephelides
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Skin Discolouration
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Nail Pigmentation
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Skin Striae
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Acanthosis Nigricans
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Melanoderma
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Nail Discolouration
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Decubitus Ulcer
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Ingrowing Nail
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Lipodystrophy Acquired
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Pigmentation Disorder
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Post Inflammatory Pigmentation Change
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Rash Erythematous
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Rash Papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Skin Depigmentation
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Skin Lesion
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Butterfly Rash
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Dermatitis Acneiform
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Dermatitis Allergic
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Dermatitis Atopic
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Diffuse Alopecia
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Hair Colour Changes
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Ingrown Hair
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Keloid Scar
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Leukoderma
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Nail Disorder
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Nail Dystrophy
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Photosensitivity Reaction
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Pityriasis Alba
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Skin Exfoliation
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Skin Irritation
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Skin Plaque
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Skin Sensitisation
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Solar Lentigo
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Solar Urticaria
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Urticaria Thermal
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0009 affected19 at risk
EG0011 affected4 at risk
EG0023 affected10 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0022 affected10 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0022 affected10 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected19 at risk
EG0011 affected4 at risk
EG0022 affected10 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected4 at risk
EG0020 affected10 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected4 at risk
EG0020 affected10 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Abnormal Faeces
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Coeliac Disease
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Gingival Hypertrophy
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Peptic Ulcer
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Pigmentation Lip
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected4 at risk
EG0020 affected10 at risk
EG003
Rectal Haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Salivary Hypersecretion
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Tooth Discolouration
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Injection Site Pruritus
General disorders
MedDRA 23.0
Systematic Assessment
EG0005 affected19 at risk
EG0012 affected4 at risk
EG0029 affected10 at risk
EG003
Injection Site Erythema
General disorders
MedDRA 23.0
Systematic Assessment
EG0004 affected19 at risk
EG0010 affected4 at risk
EG0026 affected10 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG0003 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Injection Site Induration
General disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected19 at risk
EG0010 affected4 at risk
EG0025 affected10 at risk
EG003
Injection Site Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0022 affected10 at risk
EG003
Injection Site Oedema
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0027 affected10 at risk
EG003
Injection Site Bruising
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0022 affected10 at risk
EG003
Influenza Like Illness
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Injection Site Haematoma
General disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Chest Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Temperature Intolerance
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Feeling Cold
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Injection Site Discolouration
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Injection Site Haemorrhage
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Injection Site Hypertrophy
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Injection Site Inflammation
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Injection Site Swelling
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Oedema Peripheral
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Peripheral Swelling
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Chest Discomfort
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Chills
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Cyst
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Feeling Jittery
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Impaired Healing
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Inflammation
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Injection Site Discomfort
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Injection Site Dryness
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Injection Site Rash
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Injection Site Scab
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Injection Site Warmth
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Localised Oedema
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Thirst
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0009 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Migraine
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0022 affected10 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Taste Disorder
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Tremor
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Ageusia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Anosmia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Carpal Tunnel Syndrome
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Lumbar Radiculopathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Nystagmus
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Parosmia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Poor Quality Sleep
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 affected19 at risk
EG0011 affected4 at risk
EG0020 affected10 at risk
EG003
Covid-19
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0012 affected4 at risk
EG0020 affected10 at risk
EG003
Ear Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected4 at risk
EG0020 affected10 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Tooth Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0022 affected10 at risk
EG003
Skin Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Cystitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Fungal Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0022 affected10 at risk
EG003
Lower Respiratory Tract Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected4 at risk
EG0020 affected10 at risk
EG003
Otitis Externa
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Paronychia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected4 at risk
EG0021 affected10 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Wound Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Acute Sinusitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Asymptomatic Covid-19
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Bacterial Vaginosis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Candida Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Conjunctivitis Bacterial
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Impetigo
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Localised Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Mastoiditis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Nail Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Otitis Media
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Otitis Media Acute
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Pharyngitis Streptococcal
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Tinea Versicolour
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Vaginal Infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Melanocytic Naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0006 affected19 at risk
EG0010 affected4 at risk
EG0022 affected10 at risk
EG003
Dysplastic Naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Skin Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Eye Naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Fibroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Sweat Gland Tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Uterine Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Blood Creatine Phosphokinase Increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0002 affected19 at risk
EG0011 affected4 at risk
EG0020 affected10 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Low Density Lipoprotein Increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Urine Analysis Abnormal
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected4 at risk
EG0021 affected10 at risk
EG003
Blood Bilirubin Increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0002 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Blood Lactate Dehydrogenase Increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected4 at risk
EG0020 affected10 at risk
EG003
Blood Pressure Increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Blood Triglycerides Increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
C-Reactive Protein Increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected4 at risk
EG0020 affected10 at risk
EG003
Culture Urine Positive
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Sars-Cov-2 Test Positive
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Bilirubin Conjugated Increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Blood Cholesterol Abnormal
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Blood Cholesterol Increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Blood Lactate Dehydrogenase Decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected4 at risk
EG0020 affected10 at risk
EG003
Blood Urine Present
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
C-Reactive Protein Decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Coagulation Test Abnormal
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Forced Vital Capacity Decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Gamma-Glutamyltransferase Increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Glucose Urine Present
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
High Density Lipoprotein Decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
International Normalised Ratio Increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Protein Total Decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Thyroid Function Test Abnormal
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Total Cholesterol/Hdl Ratio Abnormal
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Transaminases Increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Urobilinogen Urine Increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected4 at risk
EG0020 affected10 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected4 at risk
EG0021 affected10 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected4 at risk
EG0020 affected10 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Flank Pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Dupuytren's Contracture
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Intervertebral Disc Degeneration
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Muscle Tightness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Pain In Jaw
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected4 at risk
EG0020 affected10 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Spinal Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Spinal Pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Tendon Pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Trigger Finger
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Trismus
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0003 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Libido Increased
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Libido Decreased
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Depressed Mood
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Sleep Disorder
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Terminal Insomnia
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Abnormal Dreams
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Affect Lability
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Aggression
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Behaviour Disorder
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Irritability
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Mood Altered
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Panic Attack
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Psychological Factor Affecting Medical Condition
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Thinking Abnormal
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Erection Increased
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected4 at risk
EG0020 affected10 at risk
EG003
Genital Hyperaesthesia
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Spontaneous Penile Erection
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0022 affected10 at risk
EG003
Erectile Dysfunction
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Breast Discharge
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Breast Mass
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Dyspareunia
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Female Sexual Arousal Disorder
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Genital Disorder Female
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Genital Dysaesthesia
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Labia Enlarged
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Menstruation Irregular
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Polymenorrhoea
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Vaginal Discharge
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Vaginal Haemorrhage
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected4 at risk
EG0020 affected10 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0022 affected10 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Rhinitis Allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected4 at risk
EG0021 affected10 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Yawning
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Pulmonary Mass
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Respiratory Distress
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Throat Irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Vitamin D Deficiency
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Food Craving
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Glucose Tolerance Impaired
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Impaired Fasting Glucose
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Abnormal Loss Of Weight
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Acidosis
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected4 at risk
EG0020 affected10 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Increased Appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Starvation Ketoacidosis
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Vitamin B12 Deficiency
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0003 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Iron Deficiency Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0022 affected10 at risk
EG003
Monocytosis
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
White Blood Cell Disorder
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Arthropod Sting
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Muscle Strain
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Skin Abrasion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Thermal Burn
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Animal Scratch
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Bone Contusion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Hand Fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Limb Injury
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Oral Contusion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Procedural Anxiety
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Wrist Fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Bundle Branch Block Right
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Tricuspid Valve Incompetence
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Ventricular Extrasystoles
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Excessive Cerumen Production
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Middle Ear Effusion
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Otorrhoea
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Leukocyturia
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Urine Abnormality
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Hot Flush
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Haematoma
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Age-Related Macular Degeneration
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Blepharal Pigmentation
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Exophthalmos
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Eye Haematoma
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Eye Haemorrhage
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Eye Pain
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Eyelid Exfoliation
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Myopia
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Visual Impairment
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Goitre
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Hypogonadism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected4 at risk
EG0020 affected10 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Anaphylactic Reaction
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Immunisation Reaction
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Hepatic Steatosis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Developmental Hip Dysplasia
Congenital, familial and genetic disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0020 affected10 at risk
EG003
Cataract Operation
Surgical and medical procedures
MedDRA 23.0
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected4 at risk
EG0021 affected10 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
All information regarding setmelanotide supplied by Rhythm to the investigator is privileged and confidential information. The investigator agrees to use this information to accomplish the study and will not use it for other purposes without consent from Rhythm. The information obtained from the clinical study will be used towards the development of setmelanotide and may be disclosed to regulatory authority(ies), other investigators, corporate partners, or consultants as required.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D025063
Chromosome Disorders
D030342
Genetic Diseases, Inborn
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C579663
setmelanotide
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0091 subjects
2 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
2 subjects
FG0051 subjects
FG0063 subjects
FG0078 subjects
FG0080 subjects
FG0092 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0092 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
22.4
± 15.28
BG00436.1± 17.23
BG00540.4± 19.62
BG00630.7± 20.16
BG00733.6± 17.88
BG00819.4± 8.10
BG00931.3± 17.13
BG01028.1± 17.30
6
BG00327
BG00422
BG0054
BG00618
BG00715
BG00810
BG00925
BG010143
Male
BG0006
BG0011
BG0024
BG00322
BG00411
BG0051
BG0069
BG0077
BG0082
BG0097
BG01070
1
BG0033
BG0042
BG0050
BG0060
BG0072
BG0082
BG0093
BG01014
Not Hispanic or Latino
BG00013
BG0014
BG0028
BG00340
BG00431
BG0055
BG00625
BG00719
BG00810
BG00929
BG010184
Unknown or Not Reported
BG0005
BG0010
BG0021
BG0036
BG0040
BG0050
BG0062
BG0071
BG0080
BG0090
BG01015
0
BG0030
BG0040
BG0050
BG0060
BG0071
BG0080
BG0090
BG0101
Asian
BG0000
BG0011
BG0020
BG0030
BG0040
BG0050
BG0061
BG0071
BG0080
BG0090
BG0103
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
Black or African American
BG0000
BG0011
BG0021
BG0033
BG0045
BG0051
BG0060
BG0075
BG0081
BG0096
BG01023
White
BG00015
BG0012
BG0029
BG00338
BG00428
BG0054
BG00623
BG00713
BG00810
BG00924
BG010166
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
Unknown or Not Reported
BG0004
BG0010
BG0020
BG0038
BG0040
BG0050
BG0063
BG0072
BG0081
BG0092
BG01020
128.04
± 28.631
BG003117.87± 32.339
BG004143.04± 30.492
BG005139.05± 30.957
BG006122.08± 43.315
BG007129.06± 39.480
BG00892.48± 24.556
BG009124.07± 33.717
BG010122.98± 36.142
126.20
± 19.344
BG003122.52± 19.697
BG004137.95± 18.529
BG005134.00± 19.038
BG006128.52± 28.772
BG007130.28± 23.029
BG008110.14± 11.807
BG009123.10± 21.101
BG010125.63± 22.162
49
OG00433
OG0055
OG00627
OG00722
OG00812
OG00932
7
OG00410
OG0050
OG00614
OG0078
OG0081
OG0099
OG002
BBS Cohort
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG003
MC4R Cohort
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG004
POMC/PCSK1/LEPR Heterozygous Cohort
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG005
POMC/PCSK1/LEPR Composite Heterozygous Cohort
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG006
POMC/PCSK1/LEPR Compound Heterozygous Cohort
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG007
SH2B1 Cohort
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG008
SMS Cohort
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG009
SRC1 Cohort
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Units
Counts
Participants
OG00019
OG0014
OG00210
OG00349
OG00433
OG0055
OG00627
OG00722
OG00812
OG00932
Title
Denominators
Categories
Title
Measurements
OG00019
OG0014
OG00210
OG00349
OG00433
OG0055
OG00627
OG00721
OG00812
OG00929
OG002
BBS Cohort
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG003
MC4R Cohort
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG004
POMC/PCSK1/LEPR Heterozygous Cohort
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG005
POMC/PCSK1/LEPR Composite Heterozygous Cohort
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG006
POMC/PCSK1/LEPR Compound Heterozygous Cohort
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG007
SH2B1 Cohort
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG008
SMS Cohort
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG009
SRC1 Cohort
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Units
Counts
Participants
OG00019
OG0014
OG00210
OG00349
OG00433
OG0055
OG00627
OG00722
OG00812
OG00932
Title
Denominators
Categories
Title
Measurements
OG000-2.58± 4.886
OG001-5.16± 3.860
OG002-4.61± 7.771
OG003-1.26± 4.851
OG004-4.74± 7.689
OG005-0.11± 2.432
OG006-7.24± 6.657
OG007-3.98± 5.164
OG008-0.14± 2.805
OG009-3.96± 4.370
OG002
BBS Cohort
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG003
MC4R Cohort
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG004
POMC/PCSK1/LEPR Heterozygous Cohort
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG005
POMC/PCSK1/LEPR Composite Heterozygous Cohort
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG006
POMC/PCSK1/LEPR Compound Heterozygous Cohort
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG007
SH2B1 Cohort
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG008
SMS Cohort
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG009
SRC1 Cohort
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Units
Counts
Participants
OG00019
OG0014
OG00210
OG00349
OG00433
OG0055
OG00627
OG00722
OG00812
OG00932
Title
Denominators
Categories
Title
Measurements
OG000-2.19± 3.685
OG001-6.38± 5.043
OG002-4.19± 5.579
OG003-0.75± 4.291
OG004-3.50± 5.817
OG005-0.31± 1.772
OG006-5.57± 5.170
OG007-2.92± 3.834
OG008-0.00± 3.651
OG009-3.34± 3.607
OG002
BBS Cohort
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG003
MC4R Cohort
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG004
POMC/PCSK1/LEPR Heterozygous Cohort
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG005
POMC/PCSK1/LEPR Composite Heterozygous Cohort
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG006
POMC/PCSK1/LEPR Compound Heterozygous Cohort
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG007
SH2B1 Cohort
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG008
SMS Cohort
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG009
SRC1 Cohort
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Units
Counts
Participants
OG00014
OG0014
OG0026
OG00336
OG00431
OG0054
OG00617
OG00719
OG0080
OG00929
Title
Denominators
Categories
Baseline: Hunger Score on Average Last 24 hours
ParticipantsOG00014
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG00336
ParticipantsOG00431
ParticipantsOG0054
ParticipantsOG00617
ParticipantsOG00719
ParticipantsOG0080
ParticipantsOG00929
Title
Measurements
OG0006.11± 2.102
OG0015.07± 1.860
OG0026.37± 1.719
OG003
Change at Month 3: Hunger Score on Average Last 24 hours
ParticipantsOG00014
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG003
Baseline: Hunger Score at Most Hungry Last 24 hours
ParticipantsOG00014
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG003
Change at Month 3: Hunger Score at Most Hungry Last 24 hours
ParticipantsOG00014
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG003
Baseline: Hunger Score in Morning
ParticipantsOG00014
ParticipantsOG0014
ParticipantsOG0026
ParticipantsOG00336
Change at Month 3: Hunger Score in Morning
ParticipantsOG00014
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG00330
OG002
BBS Cohort
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG003
MC4R Cohort
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG004
POMC/PCSK1/LEPR Heterozygous Cohort
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG005
POMC/PCSK1/LEPR Composite Heterozygous Cohort
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG006
POMC/PCSK1/LEPR Compound Heterozygous Cohort
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG007
SH2B1 Cohort
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG008
SMS Cohort
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG009
SRC1 Cohort
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Units
Counts
Participants
OG0004
OG0010
OG0020
OG0037
OG0040
OG0050
OG0063
OG0073
OG0080
OG0090
Title
Denominators
Categories
Baseline: Hunger Right Now
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0037
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0063
ParticipantsOG0073
ParticipantsOG0080
ParticipantsOG0090
Title
Measurements
OG0002.32± 0.741
OG0032.02± 1.300
OG0062.17± 1.443
OG007
Change at Month 3: Hunger Right Now
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0037
OG002
BBS Cohort
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG003
MC4R Cohort
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG004
POMC/PCSK1/LEPR Heterozygous Cohort
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG005
POMC/PCSK1/LEPR Composite Heterozygous Cohort
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG006
POMC/PCSK1/LEPR Compound Heterozygous Cohort
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG007
SH2B1 Cohort
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG008
SMS Cohort
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG009
SRC1 Cohort
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Moderate hunger (Baseline) - Severe hunger (Month 3)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Moderate hunger (Baseline) - Not answered (Month 3)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Severe hunger (Baseline) - No hunger (Month 3)
Title
Measurements
OG0001
OG0010
OG0021
OG003
Severe hunger (Baseline) - Mild hunger (Month 3)
Title
Measurements
OG0001
OG0011
OG0020
OG003
Severe hunger (Baseline) - Moderate hunger (Month 3)
Title
Measurements
OG0001
OG0010
OG0020
OG003
Severe hunger (Baseline) - Severe hunger (Month 3)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Severe hunger (Baseline) - Not answered (Month 3)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Not answered (Baseline) - No hunger (Month 3)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Not answered (Baseline) - Mild hunger (Month 3)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Not answered (Baseline) - Moderate hunger (Month 3)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Not answered (Baseline) - Severe hunger (Month 3)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Not answered (Baseline) - Not answered (Month 3)
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
BBS Cohort
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG003
MC4R Cohort
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG004
POMC/PCSK1/LEPR Heterozygous Cohort
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG005
POMC/PCSK1/LEPR Composite Heterozygous Cohort
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG006
POMC/PCSK1/LEPR Compound Heterozygous Cohort
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG007
SH2B1 Cohort
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG008
SMS Cohort
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG009
SRC1 Cohort
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
Units
Counts
Participants
OG0002
OG0010
OG0020
OG0037
OG0040
OG0051
OG0062
OG0072
OG0080
OG0092
Title
Denominators
Categories
Not hungry at all (Baseline) - Not hungry at all (Month 3)
Title
Measurements
OG0000
OG0031
OG0050
OG0060
OG0070
OG0090
Not hungry at all (Baseline) - A little hungry (Month 3)
Title
Measurements
OG0000
OG0030
OG0050
OG006
Not hungry at all (Baseline) - Moderately hungry (Month 3)
Title
Measurements
OG0000
OG0030
OG0050
OG006
Not hungry at all (Baseline) - Extremely hungry (Month 3)
Title
Measurements
OG0000
OG0031
OG0050
OG006
Not hungry at all (Baseline) - Not answered (Month 3)
Title
Measurements
OG0000
OG0030
OG0050
OG006
A little hungry (Baseline) - Not hungry at all (Month 3)
Title
Measurements
OG0000
OG0030
OG0050
OG006
A little hungry (Baseline) - A little hungry (Month 3)
Title
Measurements
OG0001
OG0031
OG0051
OG006
A little hungry (Baseline) - Moderately hungry (Month 3)
Title
Measurements
OG0000
OG0031
OG0050
OG006
A little hungry (Baseline) - Extremely hungry (Month 3)
Title
Measurements
OG0000
OG0030
OG0050
OG006
A little hungry (Baseline) - Not answered (Month 3)
Title
Measurements
OG0000
OG0030
OG0050
OG006
Moderately hungry (Baseline) - Not hungry at all (Month 3)
Title
Measurements
OG0000
OG0030
OG0050
OG006
Moderately hungry (Baseline) - A little hungry (Month 3)
Extremely hungry (Baseline) - Not answered (Month 3)
Title
Measurements
OG0000
OG0030
OG0050
OG006
Not answered (Baseline) - Not hungry at all (Month 3)
Title
Measurements
OG0000
OG0030
OG0050
OG006
Not answered (Baseline) - A little hungry (Month 3)
Title
Measurements
OG0000
OG0030
OG0050
OG006
Not answered (Baseline) - Moderately hungry (Month 3)
Title
Measurements
OG0000
OG0030
OG0050
OG006
Not answered (Baseline) - Extremely hungry (Month 3)
Title
Measurements
OG0000
OG0030
OG0050
OG006
Not answered (Baseline) - Not answered (Month 3)
Title
Measurements
OG0000
OG0030
OG0050
OG006
OG002
BBS Cohort
Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG003
MC4R Cohort
Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG004
POMC/PCSK1/LEPR Heterozygous Cohort
Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG005
POMC/PCSK1/LEPR Composite Heterozygous Cohort
Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG006
POMC/PCSK1/LEPR Compound Heterozygous Cohort
Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG007
SH2B1 Cohort
Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG008
SMS Cohort
Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.
OG009
SRC1 Cohort
Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months.