A Chronic Weight Management Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight

Study Overview
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Brief Summary
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The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and efficacy of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.

Detailed Description
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The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The results for the CWMM screening record will be reported when all the ISA's complete.

Official Title
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A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Drug: LY3305677
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a Body Mass Index (BMI) ≥30 kilograms per square meter (kg/m²) Have a BMI ≥27 kg/m²and <30 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 I 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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: The CWMM protocol includes screening assessments plus a framework for the subsequent intervention, which is the primary purpose of the protocol.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3305677 Obesity ISA OXA1<br>Participants will receive LY3305677 or placebo subcutaneously (SC). Each ISA will detail the intervention specific analysis. | Drug: LY3305677<br>* Administered SC. ISA specific interventions will be listed in the ISA.<br>Drug: Placebo<br>* Administered SC. ISA specific interventions will be listed in the ISA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Allocated to Each ISA | Each ISA will detail the intervention specific analysis. | Baseline to Week 48 |