NCT06143956RecruitingPhase 2
A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 1481 (estimated)
- First submitted
- 6 Nov 2023
- Start date
- 17 Nov 2023
- Primary completion date
- Sept 2027
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Obesity
- NCT number
- NCT06143956
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 1481
- From 17 Nov 2023 to the primary completion date, Sept 2027
- 56 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening.
- 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.
Other illness
- 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 a history of symptomatic gallbladder disease within the past 2 years.
- Have a lifetime history of suicide attempts.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (56)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cicemo Srl Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Centro de Investigaciones Metabólicas (CINME) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| CARDIAMET Investigaciones Médicas Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Not yet recruiting |
| Centro Médico Viamonte Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Mautalen Salud e Investigación Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Not yet recruiting |
| Instituto Médico Catamarca IMEC Coordinator of this site? Confirm its status | Rosario | Argentina | Not yet recruiting |
| Dent Neurologic Institute Coordinator of this site? Confirm its status | Amherst | United States | Recruiting |
| Medical Research Partners Coordinator of this site? Confirm its status | Ammon | United States | Recruiting |
| IMA Clinical Research Austin Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| The Institute for Liver Health II dba Arizona Clinical Trials - Mesa Coordinator of this site? Confirm its status | Chandler | United States | Recruiting |
| Great Lakes Clinical Trials - Ravenswood Coordinator of this site? Confirm its status | Chicago | United States | Active, not recruiting |
| CTI Clinical Research Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| StudyMetrix Research Coordinator of this site? Confirm its status | City of Saint Peters | United States | Recruiting |
| FutureSearch Trials of Dallas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Velocity Clinical Research, Dallas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Sovah Clinical Research-River District Coordinator of this site? Confirm its status | Danville | United States | Recruiting |
| Velocity Clinical Research, Syracuse Coordinator of this site? Confirm its status | East Syracuse | United States | Recruiting |
| Northeast Research Institute (NERI) Coordinator of this site? Confirm its status | Fleming Island | United States | Completed |
| NorCal Medical Research, Inc Coordinator of this site? Confirm its status | Greenbrae | United States | Recruiting |
| Medication Management Coordinator of this site? Confirm its status | Greensboro | United States | Recruiting |
| Tribe Clinical Research LLC Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| Pacific Diabetes & Endocrine Center Coordinator of this site? Confirm its status | Honolulu | United States | Completed |
| PlanIt Research, PLLC Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Velocity Clinical Research-Huntington Park Coordinator of this site? Confirm its status | Huntington Park | United States | Recruiting |
| Las Vegas Medical Research Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Monroe Biomedical Research - Louisville Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| New Horizon Research Center Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Indago Research & Health Center, Inc Coordinator of this site? Confirm its status | Miami Lakes | United States | Recruiting |
| Monroe Biomedical Research Coordinator of this site? Confirm its status | Monroe | United States | Recruiting |
| Lucas Research, Inc. Coordinator of this site? Confirm its status | Morehead City | United States | Recruiting |
| Quality Medical Research Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Knownwell Coordinator of this site? Confirm its status | Needham | United States | Recruiting |
| Lucida Clinical Trials Coordinator of this site? Confirm its status | New Bedford | United States | Recruiting |
| Lucas Research, Inc. Coordinator of this site? Confirm its status | New Bern | United States | Recruiting |
| Suncoast Clinical Research, Inc. Coordinator of this site? Confirm its status | New Port Richey | United States | Recruiting |
| Charter Research - Winter Park Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Hope Research Institute Coordinator of this site? Confirm its status | Phoenix | United States | Completed |
| North Suffolk Neurology Coordinator of this site? Confirm its status | Port Jefferson Station | United States | Completed |
| Rochester Clinical Research, LLC Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Peninsula Research Associates Coordinator of this site? Confirm its status | Rolling Hills Estates | United States | Recruiting |
| Endeavor Clinical Trials Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Tekton Research - Fredericksburg Road Coordinator of this site? Confirm its status | San Antonio | United States | Completed |
| Headlands Research - Scottsdale Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| NorthShore University Health System Coordinator of this site? Confirm its status | Skokie | United States | Completed |
| Headlands Research - Detroit Coordinator of this site? Confirm its status | Southfield | United States | Recruiting |
| Clinvest Headlands LLC Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Stamford Therapeutics Consortium Coordinator of this site? Confirm its status | Stamford | United States | Recruiting |
| Charter Research - Lady Lake Coordinator of this site? Confirm its status | The Villages | United States | Recruiting |
| Cotton O'Neil Diabetes & Endocrinology Coordinator of this site? Confirm its status | Topeka | United States | Recruiting |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Coordinator of this site? Confirm its status | Troy | United States | Recruiting |
| The Institute for Liver Health II dba Arizona Liver Health-Tucson Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
| Diablo Clinical Research, Inc. Coordinator of this site? Confirm its status | Walnut Creek | United States | Recruiting |
| Central Washington Health Services Association d/b/a Confluence Health Coordinator of this site? Confirm its status | Wenatchee | United States | Recruiting |
| Texas Valley Clinical Research Coordinator of this site? Confirm its status | Weslaco | United States | Recruiting |
| Iowa Diabetes and Endocrinology Research Center Coordinator of this site? Confirm its status | West Des Moines | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.