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

Phase 2

Completed

• Conditions: Obesity; Overweight and Obesity
• Interventions: Drug: LY3841136; Drug: Placebo

• Registration Number: NCT06230523
• Lead Sponsor: Eli Lilly and Company

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 13 visits.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-21
• Study First Submitted QC: 2024-01-21
• Study First Posted: 2024-01-30
• Study Start: 2024-02-05
• Primary Completion: 2025-05-30
• Status Verified: 2025-08
• Study Completion: 2025-08-14
• Last Update Submitted: 2025-08-27
• Last Update Posted: 2025-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

Inclusion Criteria

W8M-MC-LAA1

• Are males and females who agree to abide by the reproductive and contraceptive requirements

W8M-MC-CWMM:

• BMI ≥30 kilograms per square meter (kg/m²) or

• Have a BMI ≥27 kg/m² and <30 kg/m² with at least one of the following weight-related comorbidities:

  • hypertension: on blood pressure (BP)-lowering medication
  • dyslipidemia: on lipid-lowering medication
  • cardiovascular (CV) disease: for example, ischemic CV disease, New York Heart Association (NYHA) Functional Classification Class 1 or II Heart Failure
  • obstructive sleep apnea

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3841136 Dose 1	LY3841136	Participants will receive LY3841136 subcutaneously (SC)
LY3841136 Dose 3	LY3841136	Participants will receive LY3841136 SC
LY3841136 Dose 4	LY3841136	Participants will receive LY3841136 SC.
LY3841136 Dose 5	LY3841136	Participants will receive LY3841136 SC
Placebo	Placebo	Participants will receive LY3841136 matching placebo
LY3841136 Dose 2	LY3841136	Participants will receive LY3841136 SC
LY3841136 Dose 6	LY3841136	Participants will receive LY3841136 SC

Primary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Body Weight	Baseline, Week 48

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Body Weight	Baseline, Week 48
Change from Baseline in Body Mass Index (BMI)	Baseline, Week 48
PK: Maximum Concentration (Cmax) of LY3841136	Baseline to Week 48
Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3841136	Baseline to Week 48
Percentage of Participants Who Achieve ≥5% Body Weight Reduction	Baseline to Week 48
Percentage of Participants Who Achieve ≥10% Body Weight Reduction	Baseline to Week 48

Trial Locations

Locations (46)

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

Headlands Research - Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

The Institute for Liver Health II dba Arizona Liver Health-Tucson; 🇺🇸 Tucson, Arizona, United States

NorCal Medical Research, Inc; 🇺🇸 Greenbrae, California, United States

Velocity Clinical Research, Huntington Park; 🇺🇸 Huntington Park, California, United States

Peninsula Research Associates; 🇺🇸 Rolling Hills Estates, California, United States

Diablo Clinical Research, Inc.; 🇺🇸 Walnut Creek, California, United States

Northeast Research Institute (NERI); 🇺🇸 Fleming Island, Florida, United States

Suncoast Clinical Research, Inc.; 🇺🇸 New Port Richey, Florida, United States

Charter Research - Winter Park; 🇺🇸 Orlando, Florida, United States

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