A Study of LY3549492 in Adults With Obesity or Overweight With Type 2 Diabetes

NCT ID: NCT07030868

Last Updated: 2025-08-29

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-19

Study Completion Date

2025-07-29

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 treatment with LY3549492 compared to placebo in adult participants with obesity or who are overweight with type 2 diabetes.

Participation in the study will last about 11 months.

Detailed Description

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Conditions

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Obesity Overweight Type 2 Diabetes

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

LY6249492

Intervention Type DRUG

Administered orally

LY3549492 Dose 2 Fast Titration

Participants will receive LY3549492 orally

Group Type EXPERIMENTAL

LY6249492

Intervention Type DRUG

Administered orally

LY3549492 Dose 2 Slow Titration

Participants will receive LY3549492 orally

Group Type EXPERIMENTAL

LY6249492

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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LY6249492

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

W8M-MC-GN02:

* Assigned male at birth
* Assigned female at birth, who are of non-childbearing potential
* Have type 2 diabetes

W8M-MC-CWMM:

* Have a BMI ≥27 kilograms per square meter (kg/m²)
* Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss

Exclusion Criteria

W8M-MC-GN02:

* Individuals who are of childbearing potential
* Have a history of acute or chronic pancreatitis
* 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.

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 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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HOPE Research Institute

Phoenix, Arizona, United States

Site Status

Headlands Research - Scottsdale

Scottsdale, 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 - Ravenswood

Chicago, 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

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

Clinvest Headlands Llc

Springfield, Missouri, United States

Site Status

Las Vegas Medical Research

Las Vegas, Nevada, United States

Site Status

Velocity Clinical Research, Syracuse

East Syracuse, New York, United States

Site Status

Rochester Clinical Research, LLC

Rochester, New York, 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

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

Centro Médico Viamonte

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Consultorio de Investigación Clínica EMO SRL

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, , Argentina

Site Status

Countries

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United States Argentina

Related Links

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https://trials.lilly.com/en-US/trial/619929

A Study of LY3549492 in Adults With Obesity or Overweight With Type 2 Diabetes

Other Identifiers

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W8M-MC-GN02

Identifier Type: OTHER

Identifier Source: secondary_id

W8M-MC-CWMM

Identifier Type: OTHER

Identifier Source: secondary_id

27321

Identifier Type: -

Identifier Source: org_study_id

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