A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight

Phase
Recruitment status
Participants
Lead sponsor
Eli Lilly and Company
Start date
Number of sites

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
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Actual participants
Participants
Participant count basis
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Eli Lilly and Company
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design

  1. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

Sources for outcomes

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.
Sources for eligibility

  • 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.

Sources for sites

Other registry identifiers

  • W8M-MC-LAA1
Sources for references

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)