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

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

ArmDescriptionAssigned Intervention
Experimental
LY3841136 Dose 1
Participants will receive LY3841136 subcutaneously (SC)
  • Drug: LY3841136
    Administered SC.
Experimental
LY3841136 Dose 2
Participants will receive LY3841136 SC
  • Drug: LY3841136
    Administered SC.
Experimental
LY3841136 Dose 3
Participants will receive LY3841136 SC
  • Drug: LY3841136
    Administered SC.
Experimental
LY3841136 Dose 4
Participants will receive LY3841136 SC.
  • Drug: LY3841136
    Administered SC.
Experimental
LY3841136 Dose 5
Participants will receive LY3841136 SC
  • Drug: LY3841136
    Administered SC.
Experimental
LY3841136 Dose 6
Participants will receive LY3841136 SC
  • Drug: LY3841136
    Administered SC.
Placebo Comparator
Placebo
Participants will receive LY3841136 matching placebo
  • Drug: Placebo
    Administered SC.

Recruiting Locations

More Details

NCT ID
NCT06230523
Status
Active, not recruiting
Sponsor
Eli Lilly and Company

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.