A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight
- 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.
- Short 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2025-08-14
- First posted
- 2024-01-30
- Registry last updated
- 2026-06-24
- Primary completion date
- 2025-05-30
- Start date
- 2024-02-05
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Eli Lilly and Company
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06230523
- ClinicalTrials.gov ID
- NCT06230523
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Percent Change From Baseline in Body Weight at Week 48
Timeframe: Baseline, 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.
Change From Baseline in Body Weight at Week 48
Timeframe: Baseline, 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.
Mean Percentage of Participants Who Achieved Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline to Week 48
Timeframe: 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.
Mean Percentage of Participants Who Achieved ≥ 10% Body Weight Reduction From Baseline to Week 48
Timeframe: 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.
Change From Baseline in Body Mass Index (BMI) at Week 48
Timeframe: Baseline, 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.
Pharmacokinetics (PK): Area Under the Curve (AUC) of Eloralintide at Steady State
Timeframe: 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 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).
PK: Maximum Concentration (Cmax) of Eloralintide at Steady State
Timeframe: 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 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).
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
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.
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.
- The Institute for Liver Health II dba Arizona Clinical Trials - MesaChandler, United States
- Headlands Research - ScottsdaleScottsdale, United States
- The Institute for Liver Health II dba Arizona Liver Health-TucsonTucson, United States
- NorCal Medical Research, IncGreenbrae, United States
- Velocity Clinical Research, Huntington ParkHuntington Park, United States
- Peninsula Research AssociatesRolling Hills Estates, United States
- Diablo Clinical Research, Inc.Walnut Creek, United States
- Northeast Research Institute (NERI)Fleming Island, United States
- Suncoast Clinical Research, Inc.New Port Richey, United States
- Charter Research - Winter ParkOrlando, United States
- Charter Research - Lady LakeThe Villages, United States
- Pacific Diabetes & Endocrine CenterHonolulu, United States
- Medical Research PartnersAmmon, United States
- Great Lakes Clinical Trials - AndersonvilleChicago, United States
- Great Lakes Clinical Trials - RavenswoodChicago, United States
- NorthShore University Health SystemSkokie, United States
- Iowa Diabetes and Endocrinology Research CenterWest Des Moines, United States
- Cotton O'Neil Diabetes & EndocrinologyTopeka, United States
- L-MARC Research CenterLouisville, United States
- KnownwellNeedham, United States
- Lucida Clinical TrialsNew Bedford, United States
- Headlands Research - DetroitSouthfield, United States
- Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroy, United States
- StudyMetrix ResearchCity of Saint Peters, United States
- Las Vegas Medical ResearchLas Vegas, United States
And 18 more, listed on the interactive page.
- PubMed 41207310Related publication
- Related resource (trials.lilly.com)
Other registry identifiers
- W8M-MC-LAA1
Related records
Drugs (1)
Lead sponsors (1)
Conditions (2)
- Obesity disorder Primary condition
- Overnutrition