Purpose

The main purpose of this study, performed under a master protocol W8M-MC-CWMM (NCT06143956), is to investigate weight management efficacy and safety with LY3305677 compared with placebo and in adult participants with obesity or overweight. The study will last about 62 weeks.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

W8M-MC-OXA1: - Are males and females who agree to abide by the reproductive and contraceptive requirements W8M-MC-CWMM: - Have a BMI ≥27 kilograms per square meter (kg/m²)

Exclusion Criteria

W8M-MC-OXA1: - Have any prior diagnosis of diabetes mellitus, that is type 2 diabetes mellitus (T2DM), or rare forms 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 a history of New York Heart Association (NYHA) Functional Classification I-IV CHF. - Participants with hypertension who do not have well-controlled blood pressure (BP) (>140/90 mmHg), regardless of antihypertensive treatment. Participants receiving treatment for hypertension should be on a stable antihypertensive regimen for at least 3 months prior to screening. Note: If the investigator anticipates a need to add antihypertensive medication during the study, the participant should not be included in the ambulatory blood pressure monitoring (ABPM) procedures. 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 a history of symptomatic gallbladder disease within the past 2 years. - 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
LY3305677 Dose 1
Participants will receive LY3305677 subcutaneously (SC).
  • Drug: LY3305677
    Administered SC
Experimental
LY3305677 Dose 2
Participants will receive LY3305677 SC.
  • Drug: LY3305677
    Administered SC
Experimental
LY3305677 Dose 3
Participants will receive LY3305677 SC.
  • Drug: LY3305677
    Administered SC
Placebo Comparator
Placebo
Participants will receive LY3305677 matching placebo.
  • Drug: Placebo
    Administered SC

Recruiting Locations

More Details

NCT ID
NCT06124807
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.