Study of REGN4461, a Leptin Receptor Agonist Antibody, in... | NCT04159415 | Trialant
NCT04159415
Sponsor
Regeneron Pharmaceuticals
Status
Completed
Last Update Posted
Jun 15, 2026Actual
Enrollment
16Actual
Phase
Phase 2
Conditions
Generalized Lipodystrophy
Interventions
Placebo
Low-Dose REGN4461
High-dose REGN4461
Countries
United States
Peru
Russia
Turkey (Türkiye)
Protocol Section
Identification Module
NCT ID
NCT04159415
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
R4461-GLD-1875
Secondary IDs
ID
Type
Description
Link
2019-000614-11
EudraCT Number
Brief Title
Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study of REGN4461, a Leptin Receptor Agonist Antibody, in Patients With Generalized Lipodystrophy
Acronym
Not provided
Organization
Regeneron PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
May 2026
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
Jan 7, 2020Actual
Primary Completion Date
Jan 5, 2022Actual
Completion Date
Sep 24, 2024Actual
First Submitted Date
Nov 7, 2019
First Submission Date that Met QC Criteria
Nov 7, 2019
First Posted Date
Nov 12, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Dec 18, 2024
Results First Submitted that Met QC Criteria
Feb 3, 2025
Results First Posted Date
Feb 25, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 4, 2023
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Feb 25, 2025Actual
Last Update Submitted Date
May 26, 2026
Last Update Posted Date
Jun 15, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Regeneron PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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 primary objectives of the study are to estimate the effects of REGN4461 on glycemic parameters in the subset of patients with elevated baseline hemoglobin A1c levels (HbA1c ≥7%) and to estimate the effects of REGN4461 on fasting triglyceride levels in the subset of patients with elevated baseline fasting triglycerides (TG ≥250 mg/dL).
The secondary objectives are to estimate the effects of REGN4461 on a composite endpoint of changes in either HbA1c or fasting TG for all patients, estimate the effects of 3 dose levels of REGN4461 on glycemic parameters and fasting TG, to estimate the effects of REGN4461 on insulin sensitivity, to evaluate the safety and tolerability of REGN4461 and to evaluate the pharmacokinetics (PK) and immunogenicity of REGN4461.
Absolute Change From Baseline in Participants With Elevated Baseline Hemoglobin A1c (HbA1c ≥7%) at Week 8
Absolute change from baseline in HbA1c for subgroup of participants with baseline HbA1c ≥7% reported
Baseline, Week 8
Absolute Change From Baseline in Fasting Glucose at Week 8
Absolute change from baseline in fasting glucose for subgroup of participants with baseline HbA1c ≥7% reported
Baseline, Week 8
Absolute Change From Baseline in Weighted Mean Glucose (WMG) at Week 8
Absolute change from baseline in WMG for subgroup of participants with baseline HbA1c ≥7% reported
Baseline, Week 8
Percent Change From Baseline in Fasting Triglycerides (TG) at Week 8
Percent change from baseline in participants with elevated baseline fasting TG (fasting TG ≥250 mg/dL) reported
Baseline, Week 8
Secondary Outcomes
Measure
Description
Time Frame
Absolute Change From Baseline in HbA1c and Fasting TG Composite Endpoint at Week 8
The composite score is calculated for each individual participant using baseline and Week 8 measurements of HbA1c and fasting TG.
For each participant, a Z-score is calculated separately for HbA1c and fasting TG, rescaling the change from baseline based on the standard deviation of the baseline value for all participants, as a way of standardizing the change value.
The composite score uses one or both of the calculated Z-scores depending on which parameters were abnormal at baseline. If both, then the participant's composite is the average of the two parameter Z-scores.
At the participant level, a Z-score of zero for either parameter indicates no change in that metabolic parameter, but a composite Z-score of zero can also reflect offsetting changes in metabolic parameters. A negative Z-score would be interpreted as an overall improvement in metabolic function, but a negative Z-score can also result from a decrease in one parameter not being canceled by an increase in the other.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Diagnosis of congenital or acquired generalized lipodystrophy (GLD), as defined in the protocol
Presence of one or both of the following metabolic abnormalities at screening:
HbA1c ≥ 7% OR
Fasting TG ≥250 mg/dL
Generally stable diet (based on patient's recall) and medication regimen (that optimizes treatment for their metabolic disease) for at least 3 months prior to the screening visit
Key Exclusion Criteria:
Treatment with metreleptin within 1 month of the screening visit
Treatment with over-the-counter or prescription medications for weight loss within 3 months prior to the screening visit
Treatment with oral glucocorticoids >7.5 mg prednisone equivalents per day within 3 months prior to screening visit or plans to begin treatment with oral glucocorticoids >7.5 mg prednisone equivalents per day during the study period
History of Human Immunodeficiency Virus (HIV) or HIV seropositivity at screening visit
Uncontrolled infection with hepatitis B or hepatitis C infection, or known active tuberculosis at screening
Participation in any clinical research study evaluating an Investigational product (IP) or therapy within 3 months and less than 5 half-lives of IP prior to the screening visit.
Pregnant or breast-feeding women
NOTE: Other protocol defined inclusion/exclusion criteria apply.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
12 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
Clinical Trial Management
Regeneron Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Regeneron Research Site
Bethesda
Maryland
20892
United States
Regeneron Research Site
References Module
Citations
Not provided
See Also Links
Label
URL
A Plain Language Summary is available on TrialSummaries.com
All individual patient data (IPD) that underlie publicly available results will be considered for sharing
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame
Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Access Criteria
Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
24-week double-blind treatment period (DBTP) comprised of 3 sequential 8-week DBTPs (1- 3). Participants progressed from DBTP 1 (day 1 to week 8) to DBTP 2 (weeks 8 to 16) to DBTP 3 (weeks 16 to 24). Here during DBTP 1, participants in treatment arm A received placebo subcutaneously (SC) once a week (QW) from day 1 to week 8.
Periods
Title
Milestones
Reasons Not Completed
Double-blind Treatment Period (DBTP) 1
Type
Comment
Milestone Data
STARTED
Randomized and Treated; Started DBTP 1 (day 1 to week 8)
24-week DBTP comprised of 3 sequential 8-week DBTPs (1- 3): DBTP 1 (day 1 to week 8) to DBTP 2 (weeks 8 to 16) to DBTP 3 (weeks 16 to 24). Here during DBTP 1, participants received low-dose REGN4461 SC QW from day 1 to week 8.
FG002
Treatment Sequence A, DBTP 2: Low-dose REGN4461 SC QW
Participants progressed from DBTP 1 to DBTP 2 (weeks 8 to 16). Here during DBTP 2, participants in treatment sequence A transitioned to receive low-dose REGN4461 SC QW from weeks 8 to 16.
Participants progressed from DBTP 1 to DBTP 2. Here during DBTP 2, participants in treatment sequence B transitioned to receive medium-dose REGN4461 SC QW from weeks 8 to 16.
FG004
Treatment Sequence A, DBTP 3: Medium-dose REGN4461 SC QW
Participants progressed from DBTP 2 to DBTP 3 (weeks 16 to 24). Here during DBTP 3, participants in treatment sequence A transitioned to receive medium-dose REGN4461 SC QW from weeks 16 to 24.
Participants progressed from DBTP 2 to DBTP 3. Here during DBTP 3, participants in treatment sequence B continued to receive medium-dose REGN4461 SC QW from weeks 16 to 24.
FG006
Treatment Sequence A, OLTP 4: Medium-dose REGN4461 SC QW
Following DBTP 3, participants in treatment sequence A, OLTP 4, continued to receive medium-dose REGN4461 SC QW from weeks 24 to 52 (completion of week 52 visit was considered end of study [EOS] for participants that did not continue to OLTP 5).
Following DBTP 3, participants in treatment sequence B, OLTP 4, continued to receive medium-dose REGN4461 SC QW from weeks 24 to 52 (completion of week 52 visit was considered EOS for participants that did not continue to OLTP 5).
FG008
Treatment Sequence A, OLTP 5: High-dose
Participants continuing on to OLTP 5 received high-dose REGN4461 SC QW for 52 weeks
FG009
Treatment Sequence B, OLTP 5: High-dose
Participants continuing on to OLTP 5 received high-dose REGN4461 SC QW for 52 weeks
FG0008 subjects
FG0018 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
Completed DBTP 1
FG0008 subjects
FG0018 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Double-blind Treatment Period (DBTP) 2
Type
Comment
Milestone Data
STARTED
DBTP 2 (weeks 8 to 16)
FG0000 subjects
FG0010 subjects
FG0028 subjects
FG0038 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
Completed DBTP 2
FG0000 subjects
FG0010 subjects
FG0028 subjects
FG0038 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Double-blind Treatment Period (DBTP) 3
Type
Comment
Milestone Data
STARTED
DBTP 3 (weeks 16 to 24)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0048 subjects
FG0058 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
Completed DBTP 3
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Open-Label Treatment Period (OLTP) 4
Type
Comment
Milestone Data
STARTED
Started OLTP 4
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0068 subjects
FG0078 subjects
FG0080 subjects
FG0090 subjects
Completed OLTP 4
Completed Week 52 visit
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Entered OLTP 4 Extension
Participants received ongoing study treatment at the OLTP 4 dose pending start of OLTP 5 treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
COMPLETED
Progressed to OLTP 5 treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Completed Wk 52; did not enter OLTP 4 extension
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Open-Label Treatment Period (OLTP) 5
Type
Comment
Milestone Data
STARTED
OLTP 5
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0086 subjects
FG0094 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Double-blind safety analysis set (SAF) (all randomized participants who received any double-blind study drug. Participants analyzed according to the treatment received).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Treatment Sequence A, DBTP 1-3
24-week double-blind treatment period (DBTP) comprised of 3 sequential 8-week DBTPs (1- 3). Participants progressed from DBTP 1 (day 1 to week 8) to DBTP 2 (weeks 8 to 16) to DBTP 3 (weeks 16 to 24).
BG001
Treatment Sequence B, DBTP 1 -3
24-week DBTP comprised of 3 sequential 8-week DBTPs (1- 3): DBTP 1 (day 1 to week 8) to DBTP 2 (weeks 8 to 16) to DBTP 3 (weeks 16 to 24).
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG0018
BG00216
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
BG00019.8± 4.95
BG00130.3± 16.06
BG00225.0± 12.70
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0018
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0002
BG0010
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
Secondary
Absolute Change From Baseline in HbA1c and Fasting TG Composite Endpoint at Week 8
The composite score is calculated for each individual participant using baseline and Week 8 measurements of HbA1c and fasting TG.
For each participant, a Z-score is calculated separately for HbA1c and fasting TG, rescaling the change from baseline based on the standard deviation of the baseline value for all participants, as a way of standardizing the change value.
The composite score uses one or both of the calculated Z-scores depending on which parameters were abnormal at baseline. If both, then the participant's composite is the average of the two parameter Z-scores.
At the participant level, a Z-score of zero for either parameter indicates no change in that metabolic parameter, but a composite Z-score of zero can also reflect offsetting changes in metabolic parameters. A negative Z-score would be interpreted as an overall improvement in metabolic function, but a negative Z-score can also result from a decrease in one parameter not being canceled by an increase in the other.
Subgroup of participants with baseline HbA1c ≥ 7% or TG ≥ 250 mg/dL
Posted
Least Squares Mean
Standard Error
Z-score
Baseline, Week 8
ID
Title
Description
OG000
Treatment Sequence A: DBTP 1:
Placebo SC QW from day 1 to week 8.
OG001
Treatment Sequence B: DBTP 1
REGN4461 Low-dose SC QW
Units
Counts
Participants
OG0008
OG0017
Title
Denominators
Categories
Title
Measurements
OG0000.0± 0.2
OG0010.1± 0.3
Secondary
Absolute Change From Baseline in Fasting Glucose
Number Analyzed equals number of participants analyzed at each time point
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
OG001
Treatment Sequence B
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
Units
Counts
Participants
OG000
Secondary
Absolute Change From Baseline in Weighted Mean Glucose (WMG)
Number Analyzed equals number of participants analyzed at each time point
Posted
Mean
Standard Deviation
mg/dL
Baseline, Weeks 16 and 24
ID
Title
Description
OG000
Treatment Sequence A
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3)
OG001
Treatment Sequence B
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3)
Units
Counts
Participants
OG000
Secondary
Absolute Change From Baseline in WMG for Participants With Baseline Fasting HbA1c ≥7%
Number Analyzed equals number of participants analyzed at each time point
Posted
Mean
Standard Deviation
mg/dL
Baseline, Weeks 16 and 24
ID
Title
Description
OG000
Treatment Sequence A
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3)
OG001
Treatment Sequence B
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3)
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Glucose Area Under the Concentration-time Curve (AUC0-4) During a Mixed Meal Tolerance Test (MMTT)
Number Analyzed equals number of participants analyzed at each time point
Posted
Mean
Standard Deviation
mg/dL*minutes
Baseline, Weeks 8, 16, 24
ID
Title
Description
OG000
Treatment Sequence A
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3)
OG001
Treatment Sequence B
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3)
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Glucose AUC0-4 During a MMTT for Participants With Baseline HbA1c ≥7%
Number Analyzed equals number of participants analyzed at each time point
Posted
Mean
Standard Deviation
mg/dL*minutes
Baseline, Weeks 8, 16, 24
ID
Title
Description
OG000
Treatment Sequence A
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3)
OG001
Treatment Sequence B
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3)
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Glucose Infusion Rate Per Kilogram (kg) Body Mass During Hyperinsulinemia-euglycemic Clamp
Number Analyzed equals number of participants analyzed at each time point
Posted
Mean
Standard Deviation
mg/kg/min
Baseline, Weeks 8 and 52
ID
Title
Description
OG000
Treatment Sequence A
Placebo day 1 to week 8 (DBTP 1); REGN4461 Medium-dose weeks 24 to 52 (OLTP 4)
OG001
Treatment Sequence B
REGN4461 Low-dose day 1 to week 8 (DBTP 1); Medium-dose weeks 24 to 52 (OLTP 4)
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Glucose Infusion Rate Per kg Body Mass During Hyperinsulinemia-euglycemic Clamp for Participants With Baseline HbA1c ≥7%
Number Analyzed equals number of participants analyzed at each time point
Posted
Mean
Standard Deviation
mg/kg/min
Baseline, Weeks 8 and 52
ID
Title
Description
OG000
Treatment Sequence A
Placebo day 1 to week 8 (DBTP 1); REGN4461 Medium-dose weeks 24 to 52 (OLTP 4)
OG001
Treatment Sequence B
REGN4461 Low-dose day 1 to week 8 (DBTP 1); Medium-dose weeks 24 to 52 (OLTP 4)
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Glucose Clearance Rate (kITT) During Insulin-tolerance Test (ITT)
Number Analyzed equals number of participants analyzed at each time point
Posted
Mean
Standard Deviation
%mg/dL/min
Baseline, Weeks 8 and 52
ID
Title
Description
OG000
Treatment Sequence A
Placebo day 1 to week 8 (DBTP 1); REGN4461 Medium-dose weeks 24 to 52 (OLTP 4)
OG001
Treatment Sequence B
REGN4461 Low-dose day 1 to week 8 (DBTP 1); Medium-dose weeks 24 to 52 (OLTP 4)
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Glucose kITT During ITT for Participants With Baseline HbA1c ≥7%
Number Analyzed equals number of participants analyzed at each time point
Posted
Mean
Standard Deviation
%mg/dL/min
Baseline, Weeks 8 and 52
ID
Title
Description
OG000
Treatment Sequence A
Placebo day 1 to week 8 (DBTP 1); REGN4461 Medium-dose weeks 24 to 52 (OLTP 4)
OG001
Treatment Sequence B
REGN4461 Low-dose day 1 to week 8 (DBTP 1); Medium-dose weeks 24 to 52 (OLTP 4)
Units
Counts
Participants
OG000
Secondary
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Double-blind Safety Analysis Set (DBTP SAF): Randomized participants who received any double-blind study drug; OLTP safety analysis set for Period 4 (OLTP 4 SAF): Randomized participants who received any open-label treatment period 4 study drug; OLTP 5 SAF: Randomized participants who received any open-label treatment period 5 study drug.
Posted
Count of Participants
Participants
From first dose of DBTP study treatment through last dose of OLTP 5 study treatment plus 16 weeks (approximately 120 weeks)
ID
Title
Description
OG000
Treatment Sequence A
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
OG001
Treatment Sequence B
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
Units
Counts
Participants
Secondary
Concentrations of Total REGN4461 in Serum Over Time
Number Analyzed equals number of participants analyzed at each time point
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
OG001
Treatment Sequence B
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
Units
Counts
Participants
OG000
Secondary
Number of Participants With Anti-drug Antibodies (ADA) to REGN4461
Posted
Count of Participants
Participants
Approximately Week 128
ID
Title
Description
OG000
Treatment Sequence A
Placebo day 1 to week 8 (DBTP 1), REGN4461 Low-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
OG001
Treatment Sequence B
REGN4461 Low-dose day 1 to week 8 (DBTP 1), Medium-dose weeks 8 to 16 (DBTP 2), Medium-dose weeks 16 to 24 (DBTP 3), Medium-dose weeks 24 to 52 (OLTP 4), High-dose 52 weeks (OLTP 5)
Units
Counts
Participants
OG000
Primary
Absolute Change From Baseline in Participants With Elevated Baseline Hemoglobin A1c (HbA1c ≥7%) at Week 8
Absolute change from baseline in HbA1c for subgroup of participants with baseline HbA1c ≥7% reported
Glycemic analysis set (all randomized participants in only DBTP 1 who received any study drug and had elevated baseline HbA1c [HbA1c ≥7%])
Posted
Least Squares Mean
Standard Error
millimoles per mole (mmol/mol)
Baseline, Week 8
ID
Title
Description
OG000
Treatment Sequence A, DBTP 1: Placebo SC QW
24-week double-blind treatment period (DBTP) comprised of 3 sequential 8-week DBTPs (1- 3). Participants progressed from DBTP 1 (day 1 to week 8) to DBTP 2 (weeks 8 to 16) to DBTP 3 (weeks 16 to 24). Here during DBTP 1, participants in treatment arm A received placebo subcutaneously (SC) once a week (QW) from day 1 to week 8.
24-week DBTP comprised of 3 sequential 8-week DBTPs (1- 3): DBTP 1 (day 1 to week 8) to DBTP 2 (weeks 8 to 16) to DBTP 3 (weeks 16 to 24). Here during DBTP 1, participants received low-dose REGN4461 SC QW from day 1 to week 8.
Units
Counts
Primary
Absolute Change From Baseline in Fasting Glucose at Week 8
Absolute change from baseline in fasting glucose for subgroup of participants with baseline HbA1c ≥7% reported
Glycemic analysis set (all randomized participants in only DBTP 1 who received any study drug and had elevated baseline HbA1c [HbA1c ≥7%])
Posted
Least Squares Mean
Standard Error
milligrams per deciliter (mg/dL)
Baseline, Week 8
ID
Title
Description
OG000
Treatment Sequence A, DBTP 1: Placebo SC QW
24-week double-blind treatment period (DBTP) comprised of 3 sequential 8-week DBTPs (1- 3). Participants progressed from DBTP 1 (day 1 to week 8) to DBTP 2 (weeks 8 to 16) to DBTP 3 (weeks 16 to 24). Here during DBTP 1, participants in treatment arm A received placebo subcutaneously (SC) once a week (QW) from day 1 to week 8.
24-week DBTP comprised of 3 sequential 8-week DBTPs (1- 3): DBTP 1 (day 1 to week 8) to DBTP 2 (weeks 8 to 16) to DBTP 3 (weeks 16 to 24). Here during DBTP 1, participants received low-dose REGN4461 SC QW from day 1 to week 8.
Units
Counts
Participants
Primary
Absolute Change From Baseline in Weighted Mean Glucose (WMG) at Week 8
Absolute change from baseline in WMG for subgroup of participants with baseline HbA1c ≥7% reported
Glycemic analysis set (all randomized participants in only DBTP 1 who received any study drug and had elevated baseline HbA1c [HbA1c ≥7%])
Posted
Mean
Standard Error
mg/dL
Baseline, Week 8
ID
Title
Description
OG000
Treatment Sequence A, DBTP 1: Placebo SC QW
24-week double-blind treatment period (DBTP) comprised of 3 sequential 8-week DBTPs (1- 3). Participants progressed from DBTP 1 (day 1 to week 8) to DBTP 2 (weeks 8 to 16) to DBTP 3 (weeks 16 to 24). Here during DBTP 1, participants in treatment arm A received placebo subcutaneously (SC) once a week (QW) from day 1 to week 8.
24-week DBTP comprised of 3 sequential 8-week DBTPs (1- 3): DBTP 1 (day 1 to week 8) to DBTP 2 (weeks 8 to 16) to DBTP 3 (weeks 16 to 24). Here during DBTP 1, participants received low-dose REGN4461 SC QW from day 1 to week 8.
Units
Counts
Participants
Primary
Percent Change From Baseline in Fasting Triglycerides (TG) at Week 8
Percent change from baseline in participants with elevated baseline fasting TG (fasting TG ≥250 mg/dL) reported
Triglyceride analysis set (all randomized participants in only DBTP 1 who received any study drug and had elevated baseline fasting TG (TG ≥250 mg/dL)
Posted
Mean
Standard Error
percentage of change
Baseline, Week 8
ID
Title
Description
OG000
Treatment Sequence A, DBTP 1: Placebo SC QW
24-week double-blind treatment period (DBTP) comprised of 3 sequential 8-week DBTPs (1- 3). Participants progressed from DBTP 1 (day 1 to week 8) to DBTP 2 (weeks 8 to 16) to DBTP 3 (weeks 16 to 24). Here during DBTP 1, participants in treatment arm A received placebo subcutaneously (SC) once a week (QW) from day 1 to week 8.
24-week DBTP comprised of 3 sequential 8-week DBTPs (1- 3): DBTP 1 (day 1 to week 8) to DBTP 2 (weeks 8 to 16) to DBTP 3 (weeks 16 to 24). Here during DBTP 1, participants received low-dose REGN4461 SC QW from day 1 to week 8.
Units
Counts
Participants
Time Frame
From first dose of study drug through end of study (approximately 128 weeks)
Description
Not provided
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
Treatment Sequence A: DBTP 1
Placebo SC QW from day 1 to week 8
0
8
1
8
6
8
EG001
Treatment Sequence B: DBTP 1
Low-dose REGN4461 SC QW from day 1 to week 8
0
8
0
8
7
8
EG002
Treatment Sequence A: DBTP 2
Low-dose REGN4461 SC QW from weeks 8 to 16
0
8
0
8
6
8
EG003
Treatment Sequence B: DBTP 2
Medium-dose REGN4461 SC QW from weeks 8 to 16
0
8
0
8
7
8
EG004
Treatment Sequence A: DBTP 3
Medium-dose REGN4461 SC QW from weeks 16 to 24
0
8
1
8
5
8
EG005
Treatment Sequence B: DBTP 3
Medium-dose REGN4461 SC QW from weeks 16 to 24
0
8
1
8
6
8
EG006
Treatment Sequence A: OLTP 4
Medium-dose REGN4461 SC QW from weeks 24 to 52
0
8
1
8
8
8
EG007
Treatment Sequence B: OLTP 4
Medium-dose REGN4461 SC QW from weeks 24 to 52
0
8
3
8
7
8
EG008
Treatment Sequence A: OLTP 5
Participants continuing on to OLTP 5 received High-dose REGN4461 SC QW for 51 weeks
0
6
1
6
5
6
EG009
Treatment Sequence B: OLTP 5
Participants continuing on to OLTP 5 received High-dose REGN4461 SC QW for 51 weeks
0
4
1
4
3
4
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pancreatitis necrotising
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected4 at risk
Cardiac failure
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Autoimmune thyroiditis
Endocrine disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
COVID-19
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Stoma site infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Anastomotic ulcer
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Mesangioproliferative glomerulonephritis
Renal and urinary disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Uterine polyp
Reproductive system and breast disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Constipation
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected8 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected4 at risk
Food poisoning
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
COVID-19
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Genital infection fungal
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Infected dermal cyst
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hordeolum
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0012 events2 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0013 events2 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Headache
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Seizure
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0003 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Tremor
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Nail fold inflammation
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events2 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0002 events1 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Astigmatism
Eye disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Corneal neovascularisation
Eye disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Myopia
Eye disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Oedema peripheral
General disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Asthenia
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Labile hypertension
Vascular disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Peripheral artery occlusion
Vascular disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Vaccination complication
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Nasal dryness
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0022 events2 affected8 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Gingival swelling
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Antibiotic associated colitis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Ear lobe infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Furuncle
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Gingivitis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Influenza
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Laryngopharyngitis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Oropharyngeal candidiasis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Otitis media
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Otosalpingitis
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Pustule
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Tooth infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hypochloraemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Underweight
Metabolism and nutrition disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Partial seizures
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Sudden onset of sleep
Nervous system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Albuminuria
Renal and urinary disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Diabetic nephropathy
Renal and urinary disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hirsutism
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Reactive perforating collagenosis
Skin and subcutaneous tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Deficiency anaemia
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Mitral valve stenosis
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Supraventricular extrasystoles
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Diabetic retinopathy
Eye disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Chest pain
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Chills
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Cyst
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Fatigue
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hyperthermia
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Inflammation
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Injection site reaction
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0014 events2 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Pain
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Pyrexia
General disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Greater trochanteric pain syndrome
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Tendon disorder
Musculoskeletal and connective tissue disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Hypertension
Vascular disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Hypotension
Vascular disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Phlebitis
Vascular disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Middle ear inflammation
Ear and labyrinth disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Corneal abrasion
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Injury of conjunctiva
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Nail avulsion
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Osteophyte fracture
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Stoma complication
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Stoma site haemorrhage
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Traumatic haematoma
Injury, poisoning and procedural complications
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Blood potassium decreased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Blood pressure decreased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Blood pressure systolic decreased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Body temperature increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Echocardiogram abnormal
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Fungal test positive
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Neutrophil count increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Vitamin D decreased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Waist circumference increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Weight decreased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Weight increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
White blood cell count increased
Investigations
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Depression
Psychiatric disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Breast fibrosis
Reproductive system and breast disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Heavy menstrual bleeding
Reproductive system and breast disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Menstrual disorder
Reproductive system and breast disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Pruritus genital
Reproductive system and breast disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Snoring
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Vasomotor rhinitis
Respiratory, thoracic and mediastinal disorders
MedDRA (27.0)
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 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
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the Sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D008060
Lipodystrophy
D012875
Skin Diseases, Metabolic
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D052439
Lipid Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0048 subjects
FG0058 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0040 subjects
FG0050 subjects
FG0068 subjects
FG0078 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0066 subjects
FG0076 subjects
FG0080 subjects
FG0090 subjects
FG0040 subjects
FG0050 subjects
FG0066 subjects
FG0074 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0062 subjects
FG0074 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
Lost to follow-up during OLTP 4 extension
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
Completed Wk 52; discontinued during OLTP4 Ext. PI/Participant decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0086 subjects
FG0093 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
14
Male
BG0002
BG0010
BG0022
4
Not Hispanic or Latino
BG0005
BG0017
BG00212
Unknown or Not Reported
BG0000
BG0010
BG0020
2
Asian
BG0000
BG0011
BG0021
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
Black or African American
BG0000
BG0012
BG0022
White
BG0006
BG0015
BG00211
More than one race
BG0000
BG0010
BG0020
Unknown or Not Reported
BG0000
BG0010
BG0020
8
OG0018
Title
Denominators
Categories
Week 16
ParticipantsOG0008
ParticipantsOG0017
Title
Measurements
OG000-29.4± 59.80
OG001-22.0± 47.85
Week 24
ParticipantsOG0008
ParticipantsOG0017
Title
Measurements
OG000-68.8± 58.74
OG001
Week 36
ParticipantsOG0008
ParticipantsOG0018
Title
Measurements
OG000-47.6± 71.04
OG001
Week 52
ParticipantsOG0007
ParticipantsOG0017
Title
Measurements
OG000-55.1± 77.97
OG001
OLTP 5 Week 4
ParticipantsOG0006
ParticipantsOG0014
Title
Measurements
OG000-91.8± 61.29
OG001
OLTP 5 Week 12
ParticipantsOG0006
ParticipantsOG0014
Title
Measurements
OG000-82.9± 63.16
OG001
OLTP 5 Week 24
ParticipantsOG0006
ParticipantsOG0014
Title
Measurements
OG000-100.5± 55.15
OG001
OLTP 5 Week 52
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG000-91.0± 84.38
OG001
8
OG0017
Title
Denominators
Categories
Week 16
ParticipantsOG0008
ParticipantsOG0016
Title
Measurements
OG000-29.4± 59.80
OG001-26.3± 50.89
Week 24
ParticipantsOG0008
ParticipantsOG0016
Title
Measurements
OG000-68.8± 58.74
OG001
Week 36
ParticipantsOG0008
ParticipantsOG0017
Title
Measurements
OG000-47.6± 71.04
OG001
Week 52
ParticipantsOG0007
ParticipantsOG0016
Title
Measurements
OG000-55.1± 77.97
OG001
OLTP 5 Week 4
ParticipantsOG0006
ParticipantsOG0014
Title
Measurements
OG000-91.8± 61.29
OG001
OLTP 5 Week 12
ParticipantsOG0006
ParticipantsOG0014
Title
Measurements
OG000-82.9± 63.16
OG001
OLTP 5 Week 24
ParticipantsOG0006
ParticipantsOG0014
Title
Measurements
OG000-100.5± 55.15
OG001
OLTP 5 Week 52
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG000-91.0± 84.38
OG001
8
OG0018
Title
Denominators
Categories
Week 16
ParticipantsOG0008
ParticipantsOG0017
Title
Measurements
OG000-22.5± 48.21
OG001-50.2± 39.99
Week 24
ParticipantsOG0008
ParticipantsOG0017
Title
Measurements
OG000-55.1± 30.60
OG001
Week 36
ParticipantsOG0008
ParticipantsOG0018
Title
Measurements
OG000-40.2± 39.19
OG001
Week 52
ParticipantsOG0007
ParticipantsOG0017
Title
Measurements
OG000-9.7± 74.05
OG001
OLTP 5 Week 4
ParticipantsOG0006
ParticipantsOG0014
Title
Measurements
OG000-71.5± 18.79
OG001
OLTP 5 Week 12
ParticipantsOG0006
ParticipantsOG0014
Title
Measurements
OG000-56.0± 38.07
OG001
OLTP 5 Week 24
ParticipantsOG0006
ParticipantsOG0014
Title
Measurements
OG000-64.4± 29.59
OG001
OLTP 5 Week 52
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG000-77.4± 13.37
OG001
6
OG0016
Title
Denominators
Categories
Week 16
ParticipantsOG0006
ParticipantsOG0015
Title
Measurements
OG000-39.4± 36.26
OG001-45.4± 47.97
Week 24
ParticipantsOG0006
ParticipantsOG0015
Title
Measurements
OG000-62.8± 30.80
OG001
Week 36
ParticipantsOG0006
ParticipantsOG0016
Title
Measurements
OG000-48.6± 41.67
OG001
Week 52
ParticipantsOG0005
ParticipantsOG0015
Title
Measurements
OG0000.7± 85.36
OG001
OLTP 5 Week 4
ParticipantsOG0005
ParticipantsOG0014
Title
Measurements
OG000-72.2± 20.92
OG001
OLTP 5 Week 12
ParticipantsOG0005
ParticipantsOG0014
Title
Measurements
OG000-54.9± 42.46
OG001
OLTP 5 Weeks 24
ParticipantsOG0005
ParticipantsOG0014
Title
Measurements
OG000-64.0± 33.06
OG001
OLTP 5 Week 52
ParticipantsOG0005
ParticipantsOG0013
Title
Measurements
OG000-77.4± 13.37
OG001
8
OG0018
Title
Denominators
Categories
Week 16
ParticipantsOG0007
ParticipantsOG0016
Title
Measurements
OG000-0.60± 2.200
OG001-0.50± 1.664
Week 24
ParticipantsOG0008
ParticipantsOG0018
Title
Measurements
OG000-2.34± 1.897
OG001
Week 36
ParticipantsOG0008
ParticipantsOG0018
Title
Measurements
OG000-2.56± 1.985
OG001
Week 52
ParticipantsOG0007
ParticipantsOG0017
Title
Measurements
OG000-2.69± 2.120
OG001
OLTP 5 Week 12
ParticipantsOG0006
ParticipantsOG0014
Title
Measurements
OG000-3.57± 1.957
OG001
OLTP 5 Week 24
ParticipantsOG0006
ParticipantsOG0014
Title
Measurements
OG000-3.32± 2.294
OG001
OLTP 5 Week 52
ParticipantsOG0003
ParticipantsOG0013
Title
Measurements
OG000-1.67± 3.066
OG001
8
OG0017
Title
Denominators
Categories
Week 16
ParticipantsOG0007
ParticipantsOG0015
Title
Measurements
OG000-0.60± 2.200
OG001-0.36± 1.820
Week 24
ParticipantsOG0008
ParticipantsOG0017
Title
Measurements
OG000-2.34± 1.897
OG001
Week 36
ParticipantsOG0008
ParticipantsOG0017
Title
Measurements
OG000-2.56± 1.985
OG001
Week 52
ParticipantsOG0007
ParticipantsOG0016
Title
Measurements
OG000-2.69± 2.120
OG001
OLTP 5 Week 12
ParticipantsOG0006
ParticipantsOG0014
Title
Measurements
OG000-3.57± 1.957
OG001
OLTP 5 Week 24
ParticipantsOG0006
ParticipantsOG0014
Title
Measurements
OG000-3.32± 2.294
OG001
OLTP 5 Week 52
ParticipantsOG0003
ParticipantsOG0013
Title
Measurements
OG000-1.67± 3.066
OG001
8
OG0018
Title
Denominators
Categories
Week 16
ParticipantsOG0006
ParticipantsOG0015
Title
Measurements
OG000-10.626± 28.6416
OG001-7.579± 96.4257
Week 24
ParticipantsOG0007
ParticipantsOG0017
Title
Measurements
OG000-73.634± 67.7436
OG001
8
OG0017
Title
Denominators
Categories
Week 16
ParticipantsOG0006
ParticipantsOG0014
Title
Measurements
OG000-10.626± 28.6416
OG001-4.510± 111.0606
Week 24
ParticipantsOG0007
ParticipantsOG0016
Title
Measurements
OG000-73.634± 67.7436
OG001
8
OG0018
Title
Denominators
Categories
Week 8
ParticipantsOG0006
ParticipantsOG0016
Title
Measurements
OG000829.3± 12465.83
OG0011479.3± 6075.13
Week 16
ParticipantsOG0006
ParticipantsOG0015
Title
Measurements
OG000-5300.7± 12605.15
OG001
Week 24
ParticipantsOG0007
ParticipantsOG0017
Title
Measurements
OG000-18000.6± 14760.99
OG001
8
OG0017
Title
Denominators
Categories
Week 8
ParticipantsOG0006
ParticipantsOG0015
Title
Measurements
OG000829.3± 12465.83
OG0013098.2± 5145.73
Week 16
ParticipantsOG0006
ParticipantsOG0014
Title
Measurements
OG000-5300.7± 12605.15
OG001
Week 24
ParticipantsOG0007
ParticipantsOG0016
Title
Measurements
OG000-18000.6± 14760.99
OG001
8
OG0018
Title
Denominators
Categories
Week 8
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000.030± 0.4224
OG0014.789± 7.3736
Week 52
ParticipantsOG0001
ParticipantsOG0014
Title
Measurements
OG0006.256± NANA = SD not calculable (1 participant)
OG001
8
OG0017
Title
Denominators
Categories
Week 8
ParticipantsOG0002
ParticipantsOG0012
Title
Measurements
OG0000.030± 0.4224
OG0010.572± 1.4186
Week 52
ParticipantsOG0001
ParticipantsOG0013
Title
Measurements
OG0006.256± NANA = SD not calculable (1 participant)
OG001
8
OG0018
Title
Denominators
Categories
Week 8
ParticipantsOG0001
ParticipantsOG0012
Title
Measurements
OG0000.021± NANA = SD not calculable (1 participant)
OG0012.230± 2.4771
Week 52
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0002.311± 0.1712
OG001
8
OG0017
Title
Denominators
Categories
Week 8
ParticipantsOG0001
ParticipantsOG0012
Title
Measurements
OG0000.021± NANA = SD not calculable (1 participant)
OG0012.230± 2.4771
Week 52
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0002.311± 0.1712
OG001
OG0008
OG0018
Title
Denominators
Categories
DBTP 1-3
ParticipantsOG0008
ParticipantsOG0018
Title
Measurements
OG0007
OG0018
OLTP 4
ParticipantsOG0008
ParticipantsOG0018
Title
Measurements
OG0008
OG001
OLTP 5
ParticipantsOG0002
ParticipantsOG0018
Title
Measurements
OG0001
OG001
8
OG0018
Title
Denominators
Categories
Week 0 (post-dose)
ParticipantsOG0008
ParticipantsOG0018
Title
Measurements
OG0000± 0
OG00149.2± 13.8
Week 8
ParticipantsOG0008
ParticipantsOG0018
Title
Measurements
OG00045.8± 6.82
OG001
Week 16 (post-dose)
ParticipantsOG0008
ParticipantsOG0017
Title
Measurements
OG0002.34± 3.44
OG001
Week 36
ParticipantsOG0008
ParticipantsOG0018
Title
Measurements
OG00054.3± 36.4
OG001
Week 52
ParticipantsOG0007
ParticipantsOG0018
Title
Measurements
OG00060.1± 45.1
OG001
OLTP 5 Week 4
ParticipantsOG0004
ParticipantsOG0014
Title
Measurements
OG000167± 72.2
OG001
OLTP5 Week 12
ParticipantsOG0004
ParticipantsOG0014
Title
Measurements
OG000185± 67.2
OG001
OLTP5 Week 36
ParticipantsOG0003
ParticipantsOG0013
Title
Measurements
OG000156± 77.0
OG001
OLTP5 Week 52
ParticipantsOG0003
ParticipantsOG0013
Title
Measurements
OG000196± 106
OG001
8
OG0018
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Participants
OG0008
OG0017
Title
Denominators
Categories
Title
Measurements
OG000-0.1± 0.6
OG0010.2± 0.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Least Squares (LS) Mean Difference
0.2
Standard Error of the Mean
0.9
2-Sided
95
-1.9
2.3
Confidence interval (CI) based on treatment group difference (R4461 Low dose vs. placebo) of the LS means using mixed-effect model with repeated measures (MMRM) model
Superiority
OG0008
OG0017
Title
Denominators
Categories
Title
Measurements
OG00015.5± 18.6
OG00153.6± 19.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
LS Mean Difference
38.1
Standard Error of the Mean
27.3
2-Sided
95
-21.3
97.5
Confidence interval (CI) based on treatment group difference (R4461 Low dose vs. placebo) of the LS means using mixed-effect model with repeated measures (MMRM) model
Superiority
OG0008
OG0017
Title
Denominators
Categories
Title
Measurements
OG000-3.7± 19.9
OG001-3.7± 23.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Adjusted Mean Difference
0.0
Standard Error of the Mean
29.0
2-Sided
95
-56.9
56.9
Combined estimate for adjusted mean difference (SE) vs Placebo obtained by combining adjusted means and SE from ANCOVA model analyses of the different imputed data sets.
Superiority
OG0006
OG0016
Title
Denominators
Categories
Title
Measurements
OG000-6.0± 29.8
OG00111.8± 29.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Adjusted Mean Difference
17.8
Standard Error of the Mean
43.6
2-Sided
95
-67.6
103.2
Combined estimate for adjusted mean difference (SE) vs Placebo obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets.