A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight
- Conditions
- ObesityOverweight and Obesity
- Interventions
- Drug: Placebo
- Registration Number
- NCT06230523
- 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 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 13 visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 250
W8M-MC-LAA1
- Are males and females who agree to abide by the reproductive and contraceptive requirements
W8M-MC-CWMM:
-
BMI ≥30 kilograms per square meter (kg/m²) or
-
Have a BMI ≥27 kg/m² and <30 kg/m² with at least one of the following weight-related comorbidities:
- hypertension: on blood pressure (BP)-lowering medication
- dyslipidemia: on lipid-lowering medication
- cardiovascular (CV) disease: for example, ischemic CV disease, New York Heart Association (NYHA) Functional Classification Class 1 or II Heart Failure
- obstructive sleep apnea
-
Have had a stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss)
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3841136 Dose 1 LY3841136 Participants will receive LY3841136 subcutaneously (SC) LY3841136 Dose 3 LY3841136 Participants will receive LY3841136 SC LY3841136 Dose 4 LY3841136 Participants will receive LY3841136 SC. LY3841136 Dose 5 LY3841136 Participants will receive LY3841136 SC Placebo Placebo Participants will receive LY3841136 matching placebo LY3841136 Dose 2 LY3841136 Participants will receive LY3841136 SC LY3841136 Dose 6 LY3841136 Participants will receive LY3841136 SC
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Baseline, Week 48
- Secondary Outcome Measures
Name Time Method Change from Baseline in Body Weight Baseline, Week 48 Change from Baseline in Body Mass Index (BMI) Baseline, Week 48 PK: Maximum Concentration (Cmax) of LY3841136 Baseline to Week 48 Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3841136 Baseline to Week 48 Percentage of Participants Who Achieve ≥5% Body Weight Reduction Baseline to Week 48 Percentage of Participants Who Achieve ≥10% Body Weight Reduction Baseline to Week 48
Trial Locations
- Locations (46)
Headlands Research - Detroit
🇺🇸Southfield, Michigan, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
🇺🇸Troy, Michigan, United States
StudyMetrix Research
🇺🇸Saint Peters, 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
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
Spectrum Medical, Inc.
🇺🇸Danville, Virginia, United States
Central Washington Health Services Association d/b/a Confluence Health
🇺🇸Wenatchee, Washington, United States
Headlands Research - Scottsdale
🇺🇸Scottsdale, Arizona, 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
Velocity Clinical Research, Dallas
🇺🇸Dallas, Texas, United States
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
🇺🇸Chandler, 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
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.
🇺🇸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
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