A Study of LY3841136 Compared With Placebo in Adult Parti... | NCT06230523 | Trialant
NCT06230523
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jun 24, 2026Actual
Enrollment
263Actual
Phase
Phase 2
Conditions
Obesity
Overweight
Interventions
Eloralintide
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT06230523
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
18808
Secondary IDs
ID
Type
Description
Link
W8M-MC-LAA1
Other Identifier
Intervention-specific appendix (ISA) number
CWMM Master Protocol
Other Identifier
Eli Lilly and Company
Brief Title
A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight
Official Title
A Phase 2, Parallel-Group, Double-Blind Study to Investigate Weight Management With LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
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
Feb 5, 2024Actual
Primary Completion Date
May 30, 2025Actual
Completion Date
Aug 14, 2025Actual
First Submitted Date
Jan 21, 2024
First Submission Date that Met QC Criteria
Jan 21, 2024
First Posted Date
Jan 30, 2024Actual
Results Waived
Not provided
Results First Submitted Date
May 28, 2026
Results First Submitted that Met QC Criteria
May 28, 2026
Results First Posted Date
Jun 24, 2026Actual
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
May 28, 2026
Last Update Posted Date
Jun 24, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
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 main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate weight management efficacy and safety with LY3841136 compared with placebo in adult participants with obesity or overweight. The study will last about 64 weeks and may include up to 17 visits.
Detailed Description
Not provided
Conditions Module
Conditions
Obesity
Overweight
Keywords
Overnutrition
Hormones
Chronic weight management
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
263Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Participants received subcutaneous (SC) injections of eloralintide-matching placebo administered once weekly (QW) for 48 weeks.
Drug: Placebo
1 mg Eloralintide
Experimental
Participants received eloralintide 1 milligram (mg) SC QW for 48 weeks.
Drug: Eloralintide
3 mg Eloralintide
Experimental
Participants received eloralintide 3 mg SC QW for 48 weeks.
Drug: Eloralintide
6 mg Eloralintide
Experimental
Participants received eloralintide 6 mg SC QW for 48 weeks.
Drug: Eloralintide
9 mg Eloralintide
Experimental
Participants received eloralintide 9 mg SC QW for 48 weeks.
Drug: Eloralintide
6/9 mg Eloralintide
Experimental
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Eloralintide
Drug
Administered SC.
1 mg Eloralintide
3 mg Eloralintide
3/6/9 mg Eloralintide
6 mg Eloralintide
6/9 mg Eloralintide
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Body Weight at Week 48
Least squares (LS) means were calculated using a mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Treatment + Time + Sex + Baseline BMI Category + Baseline + Time*Sex +Time*Baseline BMI Category + Treatment*Time + Time*Baseline. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
Baseline, Week 48
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Body Weight at Week 48
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment + Time + Sex + Baseline BMI Category + Baseline + Time*Sex +Time*Baseline BMI Category + Treatment*Time + Time*Baseline. Variance-Covariance structure (Change from Baseline) = Unstructured.
Baseline, Week 48
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
W8M-MC-LAA1
Are males and females who agree to abide by the reproductive and contraceptive requirements
W8M-MC-CWMM:
Have a body mass index (BMI)
≥30 kilogram/square meter (kg/m²), or
≥27 kg/m² and <30 kg/m², or with at least 1 weight-related comorbidity
Have had a stable body weight for the 3 months prior to randomization (<5%) body weight gain and/or loss.
Exclusion Criteria:
W8M-MC-LAA1
Have any prior diagnosis of diabetes mellitus except gestational diabetes.
Have any of the following cardiovascular conditions within 6 months prior to screening:
acute myocardial infarction
cerebrovascular accident (stroke)
unstable angina, or
hospitalization due to congestive heart failure (CHF).
Have a history of acute or chronic pancreatitis.
Have an on-going or history of bradyarrhythmia and/or sinus bradycardia at screening and baseline.
W8M-MC-CWMM
Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed >1 year prior to screening.
Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.
Have poorly controlled hypertension.
Have a history of symptomatic gallbladder disease within the past 2 years
Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
Have a lifetime history of suicide attempts.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Billings LK, Hsia S, Bays H, Tidemann-Miller B, O'Hagan J, Tham LS, Butler A, Kazda C, Mather KJ, Coskun T. Eloralintide, a selective amylin receptor agonist for the treatment of obesity: a 48-week phase 2, multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2025 Dec 6;406(10520):2631-2643. doi: 10.1016/S0140-6736(25)02155-5. Epub 2025 Nov 6.
See Also Links
Label
URL
A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Participants received subcutaneous (SC) injections of eloralintide-matching placebo administered once weekly (QW) for 48 weeks.
FG001
1 mg Eloralintide
Participants received eloralintide 1 milligram (mg) SC QW for 48 weeks.
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
5
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
Aug 19, 2024
Jan 21, 2026
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Argentina
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: Eloralintide
3/6/9 mg Eloralintide
Experimental
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
Drug: Eloralintide
9 mg Eloralintide
LY3841136
Placebo
Drug
Administered SC.
Placebo
Mean Percentage of Participants Who Achieved Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline to Week 48
Mean percentage of participants who achieved ≥5% body weight reduction was analysed by logistic regression model with multiple imputation. Model: Variable = Baseline + Treatment + Sex + Baseline BMI Category. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 48 in imputed data sets using Rubin's rule.
Baseline to Week 48
Mean Percentage of Participants Who Achieved ≥ 10% Body Weight Reduction From Baseline to Week 48
Mean percentage of participants who achieved ≥10% body weight reduction was analysed by logistic regression model with multiple imputation. Model: Variable = Baseline + Treatment + Sex + Baseline BMI Category. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 48 in imputed data sets using Rubin's rule.
Baseline to Week 48
Change From Baseline in Body Mass Index (BMI) at Week 48
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment + Time + Sex + Baseline BMI Category + Baseline + Time*Sex +Time*Baseline BMI Category + Treatment*Time + Time*Baseline. Variance-Covariance structure (Change from Baseline) = Unstructured.
Baseline, Week 48
Pharmacokinetics (PK): Area Under the Curve (AUC) of Eloralintide at Steady State
PK samples were analyzed using a population PK model approach to estimate AUC at steady state. Data presented are Geometric Mean with 90% prediction interval (PI).
Predose at Week 0, Week 4, Week 8, Week 12, Week 24, Week 36; Post dose (2 to 6 hours after dosing) at Week 0, Week 24; Post dose (24 to 72 hours after dosing) at Week 12; random at Week 48
PK: Maximum Concentration (Cmax) of Eloralintide at Steady State
PK samples were analyzed using a population PK model approach to estimate Cmax at steady state. Data presented are Geometric Mean with 90% prediction interval (PI).
Predose at Week 0, Week 4, Week 8, Week 12, Week 24, Week 36; Post dose (2 to 6 hours after dosing) at Week 0, Week 24; Post dose (24 to 72 hours after dosing) at Week 12; random at Week 48
Headlands Research - Scottsdale
Scottsdale
Arizona
85260
United States
The Institute for Liver Health II dba Arizona Liver Health-Tucson
Tucson
Arizona
85712
United States
NorCal Medical Research, Inc
Greenbrae
California
94904
United States
Velocity Clinical Research, Huntington Park
Huntington Park
California
90255
United States
Peninsula Research Associates
Rolling Hills Estates
California
90274
United States
Diablo Clinical Research, Inc.
Walnut Creek
California
94598
United States
Northeast Research Institute (NERI)
Fleming Island
Florida
32003
United States
Suncoast Clinical Research, Inc.
New Port Richey
Florida
34652
United States
Charter Research - Winter Park
Orlando
Florida
32803
United States
Charter Research - Lady Lake
The Villages
Florida
32162
United States
Pacific Diabetes & Endocrine Center
Honolulu
Hawaii
96817
United States
Medical Research Partners
Ammon
Idaho
83406
United States
Great Lakes Clinical Trials - Andersonville
Chicago
Illinois
60640
United States
Great Lakes Clinical Trials - Ravenswood
Chicago
Illinois
60640
United States
NorthShore University Health System
Skokie
Illinois
60077
United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines
Iowa
50265
United States
Cotton O'Neil Diabetes & Endocrinology
Topeka
Kansas
66606
United States
L-MARC Research Center
Louisville
Kentucky
40213
United States
Knownwell
Needham
Massachusetts
02492
United States
Lucida Clinical Trials
New Bedford
Massachusetts
02740
United States
Headlands Research - Detroit
Southfield
Michigan
48034
United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy
Michigan
48098
United States
StudyMetrix Research
City of Saint Peters
Missouri
63303
United States
Las Vegas Medical Research
Las Vegas
Nevada
89128
United States
Dent Neurologic Institute
Amherst
New York
14226
United States
Velocity Clinical Research, Syracuse
East Syracuse
New York
13057
United States
North Suffolk Neurology
Port Jefferson Station
New York
11776
United States
Rochester Clinical Research, LLC
Rochester
New York
14609
United States
Medication Management
Greensboro
North Carolina
27405
United States
Monroe Biomedical Research
Monroe
North Carolina
28112
United States
Lucas Research, Inc.
New Bern
North Carolina
28562
United States
CTI Clinical Research Center
Cincinnati
Ohio
45212
United States
Tribe Clinical Research, LLC
Greenville
South Carolina
29607
United States
Quality Medical Research
Nashville
Tennessee
37211
United States
IMA Clinical Research Austin
Austin
Texas
78745
United States
Velocity Clinical Research, Dallas
Dallas
Texas
75230
United States
FutureSearch Trials of Dallas
Dallas
Texas
75251
United States
PlanIt Research, PLLC
Houston
Texas
77079
United States
Tekton Research - Fredericksburg Road
San Antonio
Texas
78229
United States
Endeavor Clinical Trials
San Antonio
Texas
78240
United States
Spectrum Medical, Inc.
Danville
Virginia
24541
United States
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee
Washington
98801
United States
FG002
3 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 48 weeks.
FG003
6 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 48 weeks.
FG004
9 mg Eloralintide
Participants received eloralintide 9 mg SC QW for 48 weeks.
FG005
6/9 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
FG006
3/6/9 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
.
FG00053 subjects
FG00128 subjects
FG00224 subjects
FG00328 subjects
FG00454 subjects
FG00524 subjects
FG00652 subjects
COMPLETED
FG00038 subjects
FG00115 subjects
FG00219 subjects
FG00321 subjects
FG00448 subjects
FG00519 subjects
FG00646 subjects
NOT COMPLETED
FG00015 subjects
FG00113 subjects
FG0025 subjects
FG0037 subjects
FG0046 subjects
FG0055 subjects
FG0066 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0062 subjects
Lost to Follow-up
FG0005 subjects
FG0013 subjects
FG0022 subjects
FG0033 subjects
FG004
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0006 subjects
FG0017 subjects
FG0022 subjects
FG0033 subjects
FG004
Other
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received SC injections of eloralintide-matching placebo administered QW for 48 weeks.
BG001
1 mg Eloralintide
Participants received eloralintide 1 mg SC QW for 48 weeks.
BG002
3 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 48 weeks.
BG003
6 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 48 weeks.
BG004
9 mg Eloralintide
Participants received eloralintide 9 mg SC QW for 48 weeks.
BG005
6/9 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
BG006
3/6/9 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00053
BG00128
BG00224
BG00328
BG00454
BG00524
BG00652
BG007263
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
BG00048.80± 12.30
BG00150.40± 13.93
BG00248.60± 12.17
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00040
BG00121
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00010
BG0013
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
United States
Title
Measurements
BG00053
BG00128
BG002
Body Weight
Mean
Standard Deviation
Kilograms (Kg)
Title
Denominators
Categories
Title
Measurements
BG000109.02± 21.96
BG001113.02± 34.96
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
Percent Change From Baseline in Body Weight at Week 48
Least squares (LS) means were calculated using a mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Treatment + Time + Sex + Baseline BMI Category + Baseline + Time*Sex +Time*Baseline BMI Category + Treatment*Time + Time*Baseline. Variance-Covariance structure (Percent Change from Baseline) = Unstructured.
All randomized participants who had evaluable data for this specific outcome.
Posted
Least Squares Mean
Standard Error
percent change
Baseline, Week 48
ID
Title
Description
OG000
Placebo
Participants received SC injections of eloralintide-matching placebo administered QW for 48 weeks.
OG001
1 mg Eloralintide
Participants received eloralintide 1 mg SC QW for 48 weeks.
OG002
3 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 48 weeks.
OG003
6 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 48 weeks.
OG004
9 mg Eloralintide
Participants received eloralintide 9 mg SC QW for 48 weeks.
OG005
6/9 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
OG006
3/6/9 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
Units
Counts
Participants
OG00053
OG00128
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.4± 0.91
OG001-9.4± 1.60
OG002-12.4± 1.30
OG003
Secondary
Change From Baseline in Body Weight at Week 48
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment + Time + Sex + Baseline BMI Category + Baseline + Time*Sex +Time*Baseline BMI Category + Treatment*Time + Time*Baseline. Variance-Covariance structure (Change from Baseline) = Unstructured.
All randomized participants who had evaluable data for this specific outcome.
Posted
Least Squares Mean
Standard Error
Kilograms (Kg)
Baseline, Week 48
ID
Title
Description
OG000
Placebo
Participants received SC injections of eloralintide-matching placebo administered QW for 48 weeks.
OG001
1 mg Eloralintide
Participants received eloralintide 1 mg SC QW for 48 weeks.
OG002
3 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 48 weeks.
OG003
6 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 48 weeks.
Secondary
Mean Percentage of Participants Who Achieved Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline to Week 48
Mean percentage of participants who achieved ≥5% body weight reduction was analysed by logistic regression model with multiple imputation. Model: Variable = Baseline + Treatment + Sex + Baseline BMI Category. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 48 in imputed data sets using Rubin's rule.
All randomized participants who had evaluable data for this specific outcome.
Posted
Mean
Standard Error
percentage of participants
Baseline to Week 48
ID
Title
Description
OG000
Placebo
Participants received SC injections of eloralintide-matching placebo administered QW for 48 weeks.
OG001
1 mg Eloralintide
Participants received eloralintide 1 mg SC QW for 48 weeks.
OG002
3 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 48 weeks.
OG003
6 mg Eloralintide
Secondary
Mean Percentage of Participants Who Achieved ≥ 10% Body Weight Reduction From Baseline to Week 48
Mean percentage of participants who achieved ≥10% body weight reduction was analysed by logistic regression model with multiple imputation. Model: Variable = Baseline + Treatment + Sex + Baseline BMI Category. Mean percentage of participants was calculated by combining percentage of participants achieving target at week 48 in imputed data sets using Rubin's rule.
All randomized participants who had evaluable data for this specific outcome.
Posted
Mean
Standard Error
percentage of participants
Baseline to Week 48
ID
Title
Description
OG000
Placebo
Participants received SC injections of eloralintide-matching placebo administered QW for 48 weeks.
OG001
1 mg Eloralintide
Participants received eloralintide 1 mg SC QW for 48 weeks.
OG002
3 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 48 weeks.
OG003
6 mg Eloralintide
Secondary
Change From Baseline in Body Mass Index (BMI) at Week 48
LS means were calculated using a MMRM model for post-baseline measures: Variable = Treatment + Time + Sex + Baseline BMI Category + Baseline + Time*Sex +Time*Baseline BMI Category + Treatment*Time + Time*Baseline. Variance-Covariance structure (Change from Baseline) = Unstructured.
All randomized participants who had evaluable data for this specific outcome.
Posted
Least Squares Mean
Standard Error
kilogram per square metre (kg/m^2)
Baseline, Week 48
ID
Title
Description
OG000
Placebo
Participants received SC injections of eloralintide-matching placebo administered QW for 48 weeks.
OG001
1 mg Eloralintide
Participants received eloralintide 1 mg SC QW for 48 weeks.
OG002
3 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 48 weeks.
OG003
6 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 48 weeks.
Secondary
Pharmacokinetics (PK): Area Under the Curve (AUC) of Eloralintide at Steady State
PK samples were analyzed using a population PK model approach to estimate AUC at steady state. Data presented are Geometric Mean with 90% prediction interval (PI).
All randomized participants who had evaluable data for this specific PK outcome.Dose-escalation arms (6/9 mg and 3/6/9 mg) are not included as separate columns, as their steady-state PK exposures are consistent with 9 mg QW and have been pooled into the 9 mg eloralintide arm.
Posted
Geometric Mean
90% Confidence Interval
nanogram*hour per milliliter (ng*h/mL)
Predose at Week 0, Week 4, Week 8, Week 12, Week 24, Week 36; Post dose (2 to 6 hours after dosing) at Week 0, Week 24; Post dose (24 to 72 hours after dosing) at Week 12; random at Week 48
ID
Title
Description
OG000
1 mg Eloralintide
Participants received eloralintide 1 mg SC QW for 48 weeks.
OG001
3 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 48 weeks.
OG002
6 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 48 weeks.
OG003
Secondary
PK: Maximum Concentration (Cmax) of Eloralintide at Steady State
PK samples were analyzed using a population PK model approach to estimate Cmax at steady state. Data presented are Geometric Mean with 90% prediction interval (PI).
All randomized participants who had evaluable data for this specific PK outcome.Dose-escalation arms (6/9 mg and 3/6/9 mg) are not included as separate columns, as their steady-state PK exposures are consistent with 9 mg QW and have been pooled into the 9 mg eloralintide arm.
Posted
Geometric Mean
90% Confidence Interval
nanogram per milliliter (ng/mL)
Predose at Week 0, Week 4, Week 8, Week 12, Week 24, Week 36; Post dose (2 to 6 hours after dosing) at Week 0, Week 24; Post dose (24 to 72 hours after dosing) at Week 12; random at Week 48
ID
Title
Description
OG000
1 mg Eloralintide
Participants received eloralintide 1 mg SC QW for 48 weeks.
OG001
3 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 48 weeks.
OG002
6 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 48 weeks.
OG003
Time Frame
Baseline to end of safety follow-up (up to 58 weeks)
Description
All randomized participants. Based on the planned safety analysis, adverse events were collected per the treatment regimen, irrespective of each dose level.
Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
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
Placebo
Participants received SC injections of eloralintide-matching placebo administered QW for 48 weeks.
0
53
3
53
25
53
EG001
1 mg Eloralintide
Participants received eloralintide 1 mg SC QW for 48 weeks.
0
28
3
28
15
28
EG002
3 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 48 weeks.
0
24
1
24
12
24
EG003
6 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 48 weeks.
0
28
1
28
27
28
EG004
9 mg Eloralintide
Participants received eloralintide 9 mg SC QW for 48 weeks.
0
54
3
54
40
54
EG005
6/9 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
0
24
2
24
20
24
EG006
3/6/9 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
0
52
1
52
34
52
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected24 at risk
EG0030 events0 affected28 at risk
EG0040 events0 affected54 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected52 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected28 at risk
EG0021 events1 affected24 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected28 at risk
EG0020 events0 affected24 at risk
EG003
Diverticulitis meckel's
Congenital, familial and genetic disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected24 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected24 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 28.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected24 at risk
EG003
Mastoiditis
Infections and infestations
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected24 at risk
EG003
Bladder transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 28.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected28 at risk
EG0020 events0 affected24 at risk
EG003
Transitional cell carcinoma recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants received eloralintide 9 mg SC QW for 48 weeks.
OG005
6/9 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
OG006
3/6/9 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
Units
Counts
Participants
OG00053
OG00128
OG00224
OG00328
OG00454
OG00524
OG00652
Title
Denominators
Categories
Title
Measurements
OG000-0.2± 1.01
OG001-10.2± 1.66
OG002-13.3± 1.37
OG003-18.7± 1.81
OG004-21.3± 1.41
OG005-21.0± 1.46
OG006-18.0± 1.37
Participants received eloralintide 6 mg SC QW for 48 weeks.
OG004
9 mg Eloralintide
Participants received eloralintide 9 mg SC QW for 48 weeks.
OG005
6/9 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
OG006
3/6/9 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
Units
Counts
Participants
OG00053
OG00128
OG00224
OG00328
OG00454
OG00524
OG00652
Title
Denominators
Categories
Title
Measurements
OG00031.21± 7.19
OG00171.55± 9.81
OG00287.12± 7.75
OG00384.99± 8.04
OG00492.72± 4.07
OG00597.50± 4.00
OG00690.80± 4.78
Participants received eloralintide 6 mg SC QW for 48 weeks.
OG004
9 mg Eloralintide
Participants received eloralintide 9 mg SC QW for 48 weeks.
OG005
6/9 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
OG006
3/6/9 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
Units
Counts
Participants
OG00053
OG00128
OG00224
OG00328
OG00454
OG00524
OG00652
Title
Denominators
Categories
Title
Measurements
OG00012.85± 5.37
OG00153.25± 10.76
OG00260.45± 11.06
OG00376.57± 9.27
OG00482.32± 5.55
OG00591.13± 6.33
OG00679.24± 6.17
OG004
9 mg Eloralintide
Participants received eloralintide 9 mg SC QW for 48 weeks.
OG005
6/9 mg Eloralintide
Participants received eloralintide 6 mg SC QW for 20 weeks, followed by eloralintide 9 mg SC QW for 28 weeks, for a total treatment duration of 48 weeks.
OG006
3/6/9 mg Eloralintide
Participants received eloralintide 3 mg SC QW for 4 weeks, followed by eloralintide 6 mg SC QW for 4 weeks, followed by eloralintide 9 mg SC QW for 40 weeks, for a total treatment duration of 48 weeks.
Units
Counts
Participants
OG00053
OG00128
OG00224
OG00328
OG00454
OG00524
OG00652
Title
Denominators
Categories
Title
Measurements
OG000-0.2± 0.37
OG001-3.7± 0.58
OG002-4.7± 0.50
OG003-6.7± 0.65
OG004-7.7± 0.50
OG005-7.8± 0.60
OG006-6.4± 0.47
9 mg Eloralintide
Participants received eloralintide 9 mg SC QW for 48 weeks or via dose-escalation to 9 mg by 48 weeks.
Units
Counts
Participants
OG00027
OG00123
OG00228
OG003127
Title
Denominators
Categories
Title
Measurements
OG00047300(NA to NA)90% prediction interval (24600 to 90700)
OG001148000(NA to NA)90% prediction interval (71700 to 291000)
OG002306000(NA to NA)90% prediction interval (151000 to 621000)
OG003468000(NA to NA)90% prediction interval (237000 to 997000)
9 mg Eloralintide
Participants received eloralintide 9 mg SC QW for 48 weeks or via dose-escalation to 9 mg by 48 weeks.
Units
Counts
Participants
OG00027
OG00123
OG00228
OG003127
Title
Denominators
Categories
Title
Measurements
OG000322(NA to NA)90% prediction interval (179 to 587)
OG0011010(NA to NA)90% prediction interval (524 to 1880)
OG0022090(NA to NA)90% prediction interval (1090 to 4080)
OG0033210(NA to NA)90% prediction interval (1690 to 6460)