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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

Full criteria on ClinicalTrials.gov

Sites (56)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cicemo Srl
Coordinator of this site? Confirm its status
Buenos AiresArgentinaRecruiting
Centro de Investigaciones Metabólicas (CINME)
Coordinator of this site? Confirm its status
Buenos AiresArgentinaRecruiting
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Coordinator of this site? Confirm its status
Buenos AiresArgentinaRecruiting
CARDIAMET Investigaciones Médicas
Coordinator of this site? Confirm its status
Buenos AiresArgentinaNot yet recruiting
Centro Médico Viamonte
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Buenos AiresArgentinaRecruiting
Mautalen Salud e Investigación
Coordinator of this site? Confirm its status
Buenos AiresArgentinaNot yet recruiting
Instituto Médico Catamarca IMEC
Coordinator of this site? Confirm its status
RosarioArgentinaNot yet recruiting
Dent Neurologic Institute
Coordinator of this site? Confirm its status
AmherstUnited StatesRecruiting
Medical Research Partners
Coordinator of this site? Confirm its status
AmmonUnited StatesRecruiting
IMA Clinical Research Austin
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Coordinator of this site? Confirm its status
ChandlerUnited StatesRecruiting
Great Lakes Clinical Trials - Ravenswood
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ChicagoUnited StatesActive, not recruiting
CTI Clinical Research Center
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CincinnatiUnited StatesRecruiting
StudyMetrix Research
Coordinator of this site? Confirm its status
City of Saint PetersUnited StatesRecruiting
FutureSearch Trials of Dallas
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DallasUnited StatesRecruiting
Velocity Clinical Research, Dallas
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DallasUnited StatesRecruiting
Sovah Clinical Research-River District
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DanvilleUnited StatesRecruiting
Velocity Clinical Research, Syracuse
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East SyracuseUnited StatesRecruiting
Northeast Research Institute (NERI)
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Fleming IslandUnited StatesCompleted
NorCal Medical Research, Inc
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GreenbraeUnited StatesRecruiting
Medication Management
Coordinator of this site? Confirm its status
GreensboroUnited StatesRecruiting
Tribe Clinical Research LLC
Coordinator of this site? Confirm its status
GreenvilleUnited StatesRecruiting
Pacific Diabetes & Endocrine Center
Coordinator of this site? Confirm its status
HonoluluUnited StatesCompleted
PlanIt Research, PLLC
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HoustonUnited StatesRecruiting
Velocity Clinical Research-Huntington Park
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Huntington ParkUnited StatesRecruiting
Las Vegas Medical Research
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Las VegasUnited StatesRecruiting
Monroe Biomedical Research - Louisville
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LouisvilleUnited StatesRecruiting
New Horizon Research Center
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MiamiUnited StatesRecruiting
Indago Research & Health Center, Inc
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Miami LakesUnited StatesRecruiting
Monroe Biomedical Research
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MonroeUnited StatesRecruiting
Lucas Research, Inc.
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Morehead CityUnited StatesRecruiting
Quality Medical Research
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NashvilleUnited StatesRecruiting
Knownwell
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NeedhamUnited StatesRecruiting
Lucida Clinical Trials
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New BedfordUnited StatesRecruiting
Lucas Research, Inc.
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New BernUnited StatesRecruiting
Suncoast Clinical Research, Inc.
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New Port RicheyUnited StatesRecruiting
Charter Research - Winter Park
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OrlandoUnited StatesRecruiting
Hope Research Institute
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PhoenixUnited StatesCompleted
North Suffolk Neurology
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Port Jefferson StationUnited StatesCompleted
Rochester Clinical Research, LLC
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RochesterUnited StatesRecruiting
Peninsula Research Associates
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Rolling Hills EstatesUnited StatesRecruiting
Endeavor Clinical Trials
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San AntonioUnited StatesRecruiting
Tekton Research - Fredericksburg Road
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San AntonioUnited StatesCompleted
Headlands Research - Scottsdale
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ScottsdaleUnited StatesRecruiting
NorthShore University Health System
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SkokieUnited StatesCompleted
Headlands Research - Detroit
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SouthfieldUnited StatesRecruiting
Clinvest Headlands LLC
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SpringfieldUnited StatesRecruiting
Stamford Therapeutics Consortium
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StamfordUnited StatesRecruiting
Charter Research - Lady Lake
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The VillagesUnited StatesRecruiting
Cotton O'Neil Diabetes & Endocrinology
Coordinator of this site? Confirm its status
TopekaUnited StatesRecruiting
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Coordinator of this site? Confirm its status
TroyUnited StatesRecruiting
The Institute for Liver Health II dba Arizona Liver Health-Tucson
Coordinator of this site? Confirm its status
TucsonUnited StatesRecruiting
Diablo Clinical Research, Inc.
Coordinator of this site? Confirm its status
Walnut CreekUnited StatesRecruiting
Central Washington Health Services Association d/b/a Confluence Health
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WenatcheeUnited StatesRecruiting
Texas Valley Clinical Research
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WeslacoUnited StatesRecruiting
Iowa Diabetes and Endocrinology Research Center
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West Des MoinesUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.