DRUG
LY3305677
Administered SC. ISA specific interventions will be listed in the ISA.
A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
Status
Recruiting
Phase
Phase 2
Enrollment
1,481
Locations
54
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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 CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. The results for the CWMM screening record will be reported when all the ISA's complete.
Interventions
Treatment arms and agents.
DRUG
LY3841136
Administered SC. ISA specific interventions will be listed in the ISA.
DRUG
Tirzepatide
Administered SC. ISA specific interventions will be listed in the ISA.
DRUG
LY3549492
Administered orally. ISA specific interventions will be listed in the ISA.
DRUG
LY3532226
Administered SC. ISA specific interventions will be listed in the ISA.
DRUG
Placebo
Administered SC. ISA specific interventions will be listed in the ISA.
DRUG
Placebo
Administered orally. ISA specific interventions will be listed in the ISA.
Timeline
From registration to results.
First posted
Nov 22, 2023
Study start
Nov 17, 2023
Primary completion
Sep 2027
Study completion
Feb 2028
Results posted
Not reported
Registry updated
Jul 20, 2026
Outcomes
What the study measures.
Primary outcomes
Number of Participants Allocated to Each ISA
Time frame · Baseline to Week 6
Each ISA will detail the intervention specific analysis.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Have a body mass index (BMI) * ≥30 kilogram/square meter (kg/m²), or * ≥27 kg/m² and \<30 kg/m², or with at least 1 weight-related comorbidity * 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.
Study locations
54 registered sites.
Argentina · United States. Showing up to 24 locations stored in the fast local snapshot.
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona, United States
HOPE Research Institute
Phoenix, Arizona, United States
Headlands Research - Scottsdale
Scottsdale, Arizona, United States
The Institute for Liver Health II dba Arizona Liver Health-Tucson
Tucson, Arizona, United States
NorCal Medical Research, Inc
Greenbrae, California, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Northeast Research Institute (NERI)
Fleming Island, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Indago Research & Health Center, Inc
Miami Lakes, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Charter Research - Winter Park
Orlando, Florida, United States
Charter Research - Lady Lake
The Villages, Florida, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, United States
Medical Research Partners
Ammon, Idaho, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, United States
NorthShore University Health System
Skokie, Illinois, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, United States
Monroe Biomedical Research - Louisville
Louisville, Kentucky, United States
Knownwell
Needham, Massachusetts, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.