A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight
- Conditions
- ObesityOverweight and Obesity
- Registration Number
- NCT06230523
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria:<br><br>W8M-MC-LAA1<br><br> - Are males and females who agree to abide by the reproductive and contraceptive<br> requirements<br><br>W8M-MC-CWMM:<br><br> - BMI =30 kilograms per square meter (kg/m²) or<br><br> - Have a BMI =27 kg/m² and <30 kg/m² with at least one of the following weight-related<br> comorbidities:<br><br> - hypertension: on blood pressure (BP)-lowering medication<br><br> - dyslipidemia: on lipid-lowering medication<br><br> - cardiovascular (CV) disease: for example, ischemic CV disease, New York Heart<br> Association (NYHA) Functional Classification Class 1 or II Heart Failure<br><br> - obstructive sleep apnea<br><br> - Have had a stable body weight for the 3 months prior to randomization (<5% body<br> weight gain and/or loss)<br><br>Exclusion Criteria:<br><br>W8M-MC-LAA1<br><br> - Have any prior diagnosis of diabetes mellitus except gestational diabetes.<br><br> - Have any of the following cardiovascular conditions within 6 months prior to<br> screening:<br><br> - acute myocardial infarction<br><br> - cerebrovascular accident (stroke)<br><br> - unstable angina, or<br><br> - hospitalization due to congestive heart failure (CHF).<br><br> - Have a history of acute or chronic pancreatitis.<br><br> - Have an on-going or history of bradyarrhythmia and/or sinus bradycardia at screening<br> and baseline.<br><br>W8M-MC-CWMM<br><br> - Have a prior or planned surgical treatment for obesity, except prior liposuction or<br> abdominoplasty, if performed >1 year prior to screening.<br><br> - Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of<br> ketoacidosis or hyperosmolar coma.<br><br> - Have poorly controlled hypertension.<br><br> - Have a history of symptomatic gallbladder disease within the past 2 years<br><br> - Have signs and symptoms of any liver disease other than nonalcoholic fatty liver<br> disease.<br><br> - Have a lifetime history of suicide attempts.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight
- Secondary Outcome Measures
Name Time Method Change from Baseline in Body Weight;Percentage of Participants Who Achieve =5% Body Weight Reduction;Percentage of Participants Who Achieve =10% Body Weight Reduction;Change from Baseline in Body Mass Index (BMI);Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3841136;PK: Maximum Concentration (Cmax) of LY3841136