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Completed

NCT Number: NCT06230523

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Institute for Liver Health II dba Arizona Clinical Trials - Mesa, Chandler, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eloralintide

Drug

Administered SC.

Other names: LY3841136

Placebo

Drug

Administered SC.

Primary outcomes

  1. Percent Change From Baseline in Body Weight at Week 48

    Time frame: 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.

Secondary outcomes

  1. Change From Baseline in Body Weight at Week 48

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2024
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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