Actively Recruiting
A Master Protocol for a Randomized, Controlled Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight
Led by Eli Lilly and Company · Updated on 2026-05-14
1481
Participants Needed
53
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 2 clinical trial to evaluate the safety and effectiveness of several investigational treatments for chronic weight management in adults with obesity or overweight. This master protocol study includes multiple intervention-specific appendices (ISAs) that allow for independent assessment of each treatment as they become available. The study aims to establish entry criteria and report results after all ISAs are completed. Participants will be randomly assigned to receive one of several treatments or a placebo. These treatments include LY3305677, LY3841136, tirzepatide, LY3549492, LY3532226, macupatide, and eloralintide, administered either by subcutaneous injection or orally, depending on the specific ISA. Each ISA provides detailed analysis of its respective intervention. During the study, participants will be monitored from baseline through week 6 to assess how many are allocated to each ISA. The trial uses a double-blind design to ensure unbiased results. Participants will be assessed regularly throughout their involvement, which lasts until the completion of all ISAs. Safety and efficacy data will be collected and analyzed throughout the trial.
CONDITIONS
Brief Title
A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Have a body mass index (BMI) of 30 kg/m² or higher
- Or have a BMI between 27 and less than 30 kg/m² with at least one weight-related health condition
- Have had a stable body weight (less than 5% change) for the past 3 months
You will not qualify if you...
- Prior or planned surgical treatment for obesity, except liposuction or abdominoplasty performed more than 1 year before screening
- Type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of diabetic ketoacidosis or hyperosmolar coma
- Poorly controlled high blood pressure
- Signs or symptoms of liver disease other than nonalcoholic fatty liver disease
- Recent cardiovascular events within 3 months before screening, including heart attack, stroke, unstable angina, or heart failure hospitalization
- History of symptomatic gallbladder disease within the past 2 years
- Lifetime history of suicide attempts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants are monitored as they are allocated to different intervention-specific appendices to evaluate eligibility and baseline characteristics.
Visits as scheduled per intervention-specific appendix
Trial Site Locations
Total: 53 locations
1
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona, United States, 85225
Actively Recruiting
2
HOPE Research Institute
Phoenix, Arizona, United States, 85032
Actively Recruiting
3
Headlands Research - Scottsdale
Scottsdale, Arizona, United States, 85260
Actively Recruiting
4
The Institute for Liver Health II dba Arizona Liver Health-Tucson
Tucson, Arizona, United States, 85712
Actively Recruiting
5
NorCal Medical Research, Inc
Greenbrae, California, United States, 94904
Actively Recruiting
6
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States, 90255
Actively Recruiting
7
Peninsula Research Associates
Rolling Hills Estates, California, United States, 90274
Actively Recruiting
8
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
Actively Recruiting
9
Stamford Therapeutics Consortium
Stamford, Connecticut, United States, 06905
Actively Recruiting
10
Northeast Research Institute (NERI)
Fleming Island, Florida, United States, 32003
Actively Recruiting
11
Indago Research & Health Center, Inc
Hialeah, Florida, United States, 33012
Actively Recruiting
12
New Horizon Research Center
Miami, Florida, United States, 33165
Actively Recruiting
13
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States, 34652
Actively Recruiting
14
Charter Research - Winter Park
Orlando, Florida, United States, 32803
Actively Recruiting
15
Charter Research - Lady Lake
The Villages, Florida, United States, 32162
Actively Recruiting
16
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, United States, 96817
Actively Recruiting
17
Medical Research Partners
Ammon, Idaho, United States, 83406
Actively Recruiting
18
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, United States, 60640
Actively Recruiting
19
NorthShore University Health System
Skokie, Illinois, United States, 60077
Actively Recruiting
20
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States, 50266
Actively Recruiting
21
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, United States, 66606
Actively Recruiting
22
Monroe Biomedical Research - Louisville
Louisville, Kentucky, United States, 40213
Actively Recruiting
23
Knownwell
Needham, Massachusetts, United States, 02492
Actively Recruiting
24
Lucida Clinical Trials
New Bedford, Massachusetts, United States, 02740
Actively Recruiting
25
Headlands Research - Detroit
Southfield, Michigan, United States, 48034
Actively Recruiting
26
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States, 48098
Actively Recruiting
27
StudyMetrix Research
City of Saint Peters, Missouri, United States, 63303
Actively Recruiting
28
Clinvest Headlands Llc
Springfield, Missouri, United States, 65807
Actively Recruiting
29
Las Vegas Medical Research
Las Vegas, Nevada, United States, 89128
Actively Recruiting
30
Dent Neurologic Institute
Amherst, New York, United States, 14226
Actively Recruiting
31
Velocity Clinical Research, Syracuse
East Syracuse, New York, United States, 13057
Actively Recruiting
32
North Suffolk Neurology
Port Jefferson Station, New York, United States, 11776
Actively Recruiting
33
Rochester Clinical Research, LLC
Rochester, New York, United States, 14609
Actively Recruiting
34
Medication Management
Greensboro, North Carolina, United States, 27405
Actively Recruiting
35
Monroe Biomedical Research
Monroe, North Carolina, United States, 28112
Actively Recruiting
36
Lucas Research, Inc
Morehead City, North Carolina, United States, 28557
Actively Recruiting
37
Lucas Research, Inc.
New Bern, North Carolina, United States, 28562
Actively Recruiting
38
CTI Clinical Research Center
Cincinnati, Ohio, United States, 45212
Actively Recruiting
39
Tribe Clinical Research, LLC
Greenville, South Carolina, United States, 29607
Actively Recruiting
40
Quality Medical Research
Nashville, Tennessee, United States, 37211
Actively Recruiting
41
IMA Clinical Research Austin
Austin, Texas, United States, 78745
Actively Recruiting
42
Velocity Clinical Research, Dallas
Dallas, Texas, United States, 75230
Actively Recruiting
43
FutureSearch Trials of Dallas
Dallas, Texas, United States, 75251
Actively Recruiting
44
PlanIt Research, PLLC
Houston, Texas, United States, 77079
Actively Recruiting
45
Endeavor Clinical Trials
San Antonio, Texas, United States, 78240
Actively Recruiting
46
Tekton Research - Fredericksburg Road
San Antonio, Texas, United States, 78258
Actively Recruiting
47
Texas Valley Clinical Research
Weslaco, Texas, United States, 78596
Actively Recruiting
48
Sovah Clinical Research-River District
Danville, Virginia, United States, 24541
Actively Recruiting
49
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington, United States, 98801
Actively Recruiting
50
Cicemo Srl
Buenos Aires, Argentina, 1424
Actively Recruiting
51
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, Argentina, C1056ABI
Actively Recruiting
52
Centro Médico Viamonte
Buenos Aires, Argentina, C1120AAC
Actively Recruiting
53
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Argentina, C1425AGC
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
6
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