A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight
About the study
Who can take part
INCLUSION CRITERIA
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) 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).
EXCLUSION CRITERIA
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.
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 signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
- Have any of the following cardiovascular conditions within 3 months prior to Screening:
- acute myocardial infarction
- cerebrovascular accident (stroke)
- unstable angina, or
- hospitalization due to congestive heart failure.
- Have a history of symptomatic gallbladder disease within the past 2 years.
- Have a lifetime history of suicide attempts.
Study Locations
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How to Apply
Study Details
Contition
Obesity,Overweight and Obesity
Age
18+
Phase
PHASE2
Participants Needed
165
Est. Completion Date
May 16, 2025
Treatment Type
INTERVENTIONAL
Sponsor
Eli Lilly and Company
ClinicalTrials.gov NCT Identifier
NCT06124807
Study Number
W8M-MC-OXA1
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