Current partner codePEPTIDESDE
NCT06230523·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

263

Locations

43

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Eloralintide

Administered SC.

DRUG

Placebo

Administered SC.

Timeline

From registration to results.

  1. First posted

    Jan 30, 2024

  2. Study start

    Feb 5, 2024

  3. Primary completion

    May 30, 2025

  4. Study completion

    Aug 14, 2025

  5. Results posted

    Jun 24, 2026

  6. Registry updated

    Jun 24, 2026

Outcomes

What the study measures.

Primary outcomes

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

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.

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.

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.

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.

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).

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).

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

43 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

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

Charter Research - Lady Lake

The Villages, Florida, United States

Pacific Diabetes & Endocrine Center

Honolulu, Hawaii, United States

Medical Research Partners

Ammon, Idaho, United States

Great Lakes Clinical Trials - Andersonville

Chicago, Illinois, United States

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, United States

NorthShore University Health System

Skokie, Illinois, United States

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, United States

L-MARC Research Center

Louisville, Kentucky, United States

Knownwell

Needham, Massachusetts, United States

Lucida Clinical Trials

New Bedford, Massachusetts, United States

Headlands Research - Detroit

Southfield, Michigan, United States

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, United States

StudyMetrix Research

City of Saint Peters, Missouri, United States

Related trials

More studies on Eloralintide.

Related PeptideStat pages

Put the record in context.

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