A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
- Conditions
- ObesityOverweight
- Interventions
- Registration Number
- NCT06143956
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1040
- Have a body mass index (BMI) ≥27 kg/m²
- Have had a stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss.
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3305677 Obesity ISA OXA1 LY3305677 Participants will receive LY3305677 or placebo subcutaneously (SC). Each ISA will detail the intervention specific analysis. LY3305677 Obesity ISA OXA1 Placebo Participants will receive LY3305677 or placebo subcutaneously (SC). Each ISA will detail the intervention specific analysis. LY3841136 Obesity ISA LAA1 LY3841136 Participants will receive LY3841136 or placebo SC. Each ISA will detail the intervention specific analysis. LY3841136 Obesity ISA LAA1 Placebo Participants will receive LY3841136 or placebo SC. Each ISA will detail the intervention specific analysis. LY3841136 Obesity ISA LAA2 LY3841136 Participants will receive LY3841136, tirzepatide and placebo SC. Each ISA will detail the intervention specific analysis. LY3841136 Obesity ISA LAA2 Tirzepatide Participants will receive LY3841136, tirzepatide and placebo SC. Each ISA will detail the intervention specific analysis. LY3841136 Obesity ISA LAA2 Placebo Participants will receive LY3841136, tirzepatide and placebo SC. Each ISA will detail the intervention specific analysis. LY3549492 Obesity ISA GN01 Placebo Participants will receive LY3549492 orally. Each ISA will detail the intervention specific analysis. LY3549492 Obesity ISA GN01 LY3549492 Participants will receive LY3549492 orally. Each ISA will detail the intervention specific analysis.
- Primary Outcome Measures
Name Time Method Number of Participants Allocated to Each ISA Baseline to Week 48 Each ISA will detail the intervention specific analysis.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (53)
Pacific Diabetes & Endocrine Center
🇺🇸Honolulu, Hawaii, United States
Medical Research Partners
🇺🇸Ammon, Idaho, United States
Great Lakes Clinical Trials - Andersonville
🇺🇸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
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
Knownwell
🇺🇸Needham, Massachusetts, United States
Lucida Clinical Trials
🇺🇸New Bedford, Massachusetts, United States
Headlands Research - Detroit
🇺🇸Southfield, Michigan, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
🇺🇸Troy, Michigan, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
Clinvest Headlands Llc
🇺🇸Springfield, Missouri, United States
Las Vegas Medical Research
🇺🇸Las Vegas, Nevada, United States
Dent Neurologic Institute
🇺🇸Amherst, New York, United States
Velocity Clinical Research, Syracuse
🇺🇸East Syracuse, New York, United States
North Suffolk Neurology
🇺🇸Port Jefferson Station, New York, United States
Rochester Clinical Research, LLC
🇺🇸Rochester, New York, United States
Medication Management
🇺🇸Greensboro, North Carolina, United States
Monroe Biomedical Research
🇺🇸Monroe, North Carolina, United States
Lucas Research, Inc
🇺🇸Morehead City, North Carolina, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Tribe Clinical Research, LLC
🇺🇸Greenville, South Carolina, United States
Quality Medical Research
🇺🇸Nashville, Tennessee, United States
IMA Clinical Research Austin
🇺🇸Austin, Texas, United States
Velocity Clinical Research, Dallas
🇺🇸Dallas, Texas, United States
FutureSearch Trials of Dallas
🇺🇸Dallas, Texas, United States
PlanIt Research, PLLC
🇺🇸Houston, Texas, United States
Tekton Research - Fredericksburg Road
🇺🇸San Antonio, Texas, United States
Endeavor Clinical Trials
🇺🇸San Antonio, Texas, United States
Texas Valley Clinical Research
🇺🇸Weslaco, Texas, United States
Spectrum Medical, Inc.
🇺🇸Danville, Virginia, United States
Central Washington Health Services Association d/b/a Confluence Health
🇺🇸Wenatchee, Washington, United States
HOPE Research Institute
🇺🇸Phoenix, Arizona, United States
Lucas Research, Inc.
🇺🇸New Bern, North Carolina, United States
Centro Médico Viamonte
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
🇺🇸Chandler, 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
Charter Research - Lady Lake
🇺🇸The Villages, Florida, United States
Northeast Research Institute (NERI)
🇺🇸Fleming Island, Florida, United States
Indago Research & Health Center, Inc
🇺🇸Hialeah, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Charter Research - Winter Park
🇺🇸Orlando, Florida, United States