A Study to Investigate Weight Management With LY3549492 Compared With Placebo in Adult Participants With Obesity or Overweight

NCT ID: NCT06683508

Last Updated: 2025-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-13

Study Completion Date

2026-09-30

Brief Summary

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The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to evaluate the effects of LY3549492 in adults with obesity or overweight. Participation in the study will last about one year.

Detailed Description

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Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3549492 Dose 1

Participants will receive LY3549492 orally

Group Type EXPERIMENTAL

LY3549492

Intervention Type DRUG

Administered orally

LY3549492 Dose 2

Participants will receive LY3549492 orally

Group Type EXPERIMENTAL

LY3549492

Intervention Type DRUG

Administered orally

LY3549492 Dose 3

Participants will receive LY3549492 orally

Group Type EXPERIMENTAL

LY3549492

Intervention Type DRUG

Administered orally

LY3549492 Dose 4

Participants will receive LY3549492 orally

Group Type EXPERIMENTAL

LY3549492

Intervention Type DRUG

Administered orally

LY3549492 Dose 5

Participants will receive LY3549492 orally

Group Type EXPERIMENTAL

LY3549492

Intervention Type DRUG

Administered orally

Placebo

Participants will receive Placebo orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Interventions

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LY3549492

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

W8M-MC-GN01:

* Assigned male at birth
* Assigned female at birth, who are of non-childbearing potential

W8M-MC-CWMM:

* Have a BMI of

* ≥ 30 kilograms per square meter (kg/m²) or
* ≥ 27 kg/m² and \< 30 kg/m² with at least one 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-GN01:

* Have Type 2 Diabetes Mellitus or Type 1 Diabetes Mellitus
* Have a history of acute or chronic pancreatitis
* Have renal impairment
* Individuals who are of childbearing potential

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 signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
* Have any of the following cardiovascular conditions within 3 months prior to screening:

* acute myocardial infarction
* cerebrovascular accident (stroke)
* unstable angina, or
* hospitalization due to congestive heart failure.
* Have a history of symptomatic gallbladder disease within the past 2 years
* Have a lifetime history of suicide attempts.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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The Institute for Liver Health II dba Arizona Clinical Trials - Mesa

Chandler, Arizona, United States

Site Status

HOPE Research Institute

Phoenix, Arizona, United States

Site Status

Headlands Research - Scottsdale

Scottsdale, Arizona, United States

Site Status

The Institute for Liver Health II dba Arizona Liver Health-Tucson

Tucson, Arizona, United States

Site Status

NorCal Medical Research, Inc

Greenbrae, California, United States

Site Status

Velocity Clinical Research, Huntington Park

Huntington Park, California, United States

Site Status

Peninsula Research Associates

Rolling Hills Estates, California, United States

Site Status

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Site Status

Northeast Research Institute (NERI)

Fleming Island, Florida, United States

Site Status

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Site Status

New Horizon Research Center

Miami, Florida, United States

Site Status

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Site Status

Charter Research - Winter Park

Orlando, Florida, United States

Site Status

Charter Research - Lady Lake

The Villages, Florida, United States

Site Status

Medical Research Partners

Ammon, Idaho, United States

Site Status

Great Lakes Clinical Trials - Andersonville

Chicago, Illinois, United States

Site Status

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, United States

Site Status

NorthShore University Health System

Skokie, Illinois, United States

Site Status

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Site Status

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, United States

Site Status

L-MARC Research Center

Louisville, Kentucky, United States

Site Status

Knownwell

Needham, Massachusetts, United States

Site Status

Lucida Clinical Trials

New Bedford, Massachusetts, United States

Site Status

Headlands Research - Detroit

Southfield, Michigan, United States

Site Status

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, United States

Site Status

StudyMetrix Research

City of Saint Peters, Missouri, United States

Site Status

Clinvest Headlands Llc

Springfield, Missouri, United States

Site Status

Las Vegas Medical Research

Las Vegas, Nevada, United States

Site Status

Dent Neurologic Institute

Amherst, New York, United States

Site Status

Velocity Clinical Research, Syracuse

East Syracuse, New York, United States

Site Status

North Suffolk Neurology

Port Jefferson Station, New York, United States

Site Status

Rochester Clinical Research, LLC

Rochester, New York, United States

Site Status

Medication Management

Greensboro, North Carolina, United States

Site Status

Monroe Biomedical Research

Monroe, North Carolina, United States

Site Status

Lucas Research, Inc

Morehead City, North Carolina, United States

Site Status

Lucas Research, Inc.

New Bern, North Carolina, United States

Site Status

CTI Clinical Research Center

Cincinnati, Ohio, United States

Site Status

Tribe Clinical Research, LLC

Greenville, South Carolina, United States

Site Status

Quality Medical Research

Nashville, Tennessee, United States

Site Status

IMA Clinical Research Austin

Austin, Texas, United States

Site Status

Velocity Clinical Research, Dallas

Dallas, Texas, United States

Site Status

FutureSearch Trials of Dallas

Dallas, Texas, United States

Site Status

PlanIt Research, PLLC

Houston, Texas, United States

Site Status

Tekton Research - Fredericksburg Road

San Antonio, Texas, United States

Site Status

Endeavor Clinical Trials

San Antonio, Texas, United States

Site Status

Texas Valley Clinical Research

Weslaco, Texas, United States

Site Status

Spectrum Medical, Inc.

Danville, Virginia, United States

Site Status

Central Washington Health Services Association d/b/a Confluence Health

Wenatchee, Washington, United States

Site Status

Countries

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United States

Related Links

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https://trials.lilly.com/en-US/trial/554575

A Study to Investigate Weight Management with LY3549492 Compared with Placebo in Adult Participants With Obesity or Overweight

Other Identifiers

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W8M-MC-GN01

Identifier Type: OTHER

Identifier Source: secondary_id

W8M-MC-CWMM

Identifier Type: OTHER

Identifier Source: secondary_id

27240

Identifier Type: -

Identifier Source: org_study_id

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