A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight
Purpose
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 17 visits.
Conditions
- Obesity
- Overweight and Obesity
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
W8M-MC-LAA1 - Are males and females who agree to abide by the reproductive and contraceptive requirements W8M-MC-CWMM: - Have a BMI ≥27 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-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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental LY3841136 Dose 1 |
Participants will receive LY3841136 subcutaneously (SC) |
|
Experimental LY3841136 Dose 2 |
Participants will receive LY3841136 SC |
|
Experimental LY3841136 Dose 3 |
Participants will receive LY3841136 SC |
|
Experimental LY3841136 Dose 4 |
Participants will receive LY3841136 SC. |
|
Experimental LY3841136 Dose 5 |
Participants will receive LY3841136 SC |
|
Experimental LY3841136 Dose 6 |
Participants will receive LY3841136 SC |
|
Placebo Comparator Placebo |
Participants will receive LY3841136 matching placebo |
|
Recruiting Locations
More Details
- NCT ID
- NCT06230523
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company