A Study to Investigate Weight Management With LY3549492 Compared With Placebo in Adult Participants With Obesity or Overweight
- 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
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)
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3549492 Dose 1 LY3549492 Participants will receive LY3549492 orally LY3549492 Dose 2 LY3549492 Participants will receive LY3549492 orally LY3549492 Dose 3 LY3549492 Participants will receive LY3549492 orally LY3549492 Dose 4 LY3549492 Participants will receive LY3549492 orally Placebo Placebo Participants will receive Placebo orally LY3549492 Dose 5 LY3549492 Participants will receive LY3549492 orally
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Baseline, Week 36
- Secondary Outcome Measures
Name Time Method Change from Baseline in Body Weight (kilograms) Baseline, Week 36 Percentage of Participants who Achieve ≥5% Body Weight Reduction Baseline, Week 36 Percentage of Participants who Achieve ≥10% Body Weight Reduction Baseline, Week 36 Change from Baseline in Body Mass Index (BMI) Baseline, Week 36 Pharmacokinetics (PK): Average Concentration of LY3549492 Week 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