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

Phase 2
Recruiting
Conditions
Interventions
Registration Number
NCT06683508
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 evaluate the effects of LY3549492 in adults with obesity or overweight. Participation in the study will last about one year.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
275
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 ≥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)
Read More
Exclusion Criteria

W8M-MC-GN01:

  • Have Type 2 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.

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
LY3549492 Dose 1LY3549492Participants will receive LY3549492 orally
LY3549492 Dose 2LY3549492Participants will receive LY3549492 orally
LY3549492 Dose 3LY3549492Participants will receive LY3549492 orally
LY3549492 Dose 4LY3549492Participants will receive LY3549492 orally
PlaceboPlaceboParticipants will receive Placebo orally
LY3549492 Dose 5LY3549492Participants will receive LY3549492 orally
Primary Outcome Measures
NameTimeMethod
Percent Change from Baseline in Body WeightBaseline, Week 36
Secondary Outcome Measures
NameTimeMethod
Change from Baseline in Body Weight (kilograms)Baseline, Week 36
Percentage of Participants who Achieve ≥5% Body Weight ReductionBaseline, Week 36
Percentage of Participants who Achieve ≥10% Body Weight ReductionBaseline, Week 36
Change from Baseline in Body Mass Index (BMI)Baseline, Week 36
Pharmacokinetics (PK): Average Concentration of LY3549492Week 36

Trial Locations

Locations (52)

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

🇺🇸

Chandler, Arizona, United States

Stamford Therapeutics Consortium

🇺🇸

Stamford, Connecticut, United States

Northeast Research Institute (NERI)

🇺🇸

Fleming Island, Florida, United States

Indago Research & Health Center, Inc

🇺🇸

Hialeah, Florida, United States

New Horizon Research Center

🇺🇸

Miami, 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

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

HOPE Research Institute

🇺🇸

Phoenix, 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

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

🇺🇸

Troy, Michigan, United States

StudyMetrix Research

🇺🇸

Saint Peters, Missouri, United States

Clinvest Headlands Llc

🇺🇸

Springfield, Missouri, United States

Las Vegas Medical Research

🇺🇸

Las Vegas, Nevada, United States

Dent Neurologic Institute

🇺🇸

Amherst, New York, United States

Velocity Clinical Research, Syracuse

🇺🇸

East Syracuse, New York, United States

North Suffolk Neurology

🇺🇸

Port Jefferson Station, New York, United States

Rochester Clinical Research, LLC

🇺🇸

Rochester, New York, United States

Medication Management

🇺🇸

Greensboro, North Carolina, United States

Monroe Biomedical Research

🇺🇸

Monroe, North Carolina, United States

Lucas Research, Inc

🇺🇸

Morehead City, North Carolina, United States

Lucas Research, Inc.

🇺🇸

New Bern, North Carolina, United States

CTI Clinical Research Center

🇺🇸

Cincinnati, Ohio, United States

Tribe Clinical Research, LLC

🇺🇸

Greenville, South Carolina, United States

Quality Medical Research

🇺🇸

Nashville, Tennessee, United States

IMA Clinical Research Austin

🇺🇸

Austin, Texas, United States

Velocity Clinical Research, Dallas

🇺🇸

Dallas, Texas, United States

FutureSearch Trials of Dallas

🇺🇸

Dallas, Texas, United States

PlanIt Research, PLLC

🇺🇸

Houston, Texas, United States

Tekton Research - Fredericksburg Road

🇺🇸

San Antonio, Texas, United States

Endeavor Clinical Trials

🇺🇸

San Antonio, Texas, United States

Texas Valley Clinical Research

🇺🇸

Weslaco, Texas, United States

Spectrum Medical, Inc.

🇺🇸

Danville, Virginia, United States

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

🇺🇸

Wenatchee, Washington, United States

Centro Médico Viamonte

🇦🇷

Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

🇦🇷

Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)

🇦🇷

Ciudad Autónoma de Buenos Aires, Argentina

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