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
7 other identifiers
interventional
1,217
2 countries
53
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started Nov 2023
Typical duration for phase_2 obesity
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2023
CompletedStudy Start
First participant enrolled
November 17, 2023
CompletedFirst Posted
Study publicly available on registry
November 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
April 20, 2026
April 1, 2026
2.5 years
November 6, 2023
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants Allocated to Each ISA
Each ISA will detail the intervention specific analysis.
Baseline to Week 6
Study Arms (5)
LY3305677 Obesity ISA OXA1
EXPERIMENTALParticipants will receive LY3305677 or placebo subcutaneously (SC). Each ISA will detail the intervention specific analysis.
LY3841136 Obesity ISA LAA1
EXPERIMENTALParticipants will receive LY3841136 or placebo SC. Each ISA will detail the intervention specific analysis.
LY3841136 Obesity ISA LAA2
EXPERIMENTALParticipants will receive LY3841136, tirzepatide and placebo SC. Each ISA will detail the intervention specific analysis.
LY3549492 Obesity ISA GN01
EXPERIMENTALParticipants will receive LY3549492 orally. Each ISA will detail the intervention specific analysis.
LY3549492 Obesity ISA GN02
EXPERIMENTALParticipants will receive LY3549492 or placebo orally. Each ISA will detail the intervention specific analysis.
Interventions
Administered SC. ISA specific interventions will be listed in the ISA.
Administered SC. ISA specific interventions will be listed in the ISA.
Administered SC. ISA specific interventions will be listed in the ISA.
Administered SC. ISA specific interventions will be listed in the ISA.
Administered orally. ISA specific interventions will be listed in the ISA.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona, 85225, United States
HOPE Research Institute
Phoenix, Arizona, 85032, United States
Headlands Research - Scottsdale
Scottsdale, Arizona, 85260, United States
The Institute for Liver Health II dba Arizona Liver Health-Tucson
Tucson, Arizona, 85712, United States
NorCal Medical Research, Inc
Greenbrae, California, 94904, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255, United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Northeast Research Institute (NERI)
Fleming Island, Florida, 32003, United States
Indago Research & Health Center, Inc
Hialeah, Florida, 33012, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Charter Research - Winter Park
Orlando, Florida, 32803, United States
Charter Research - Lady Lake
The Villages, Florida, 32162, United States
Pacific Diabetes & Endocrine Center
Honolulu, Hawaii, 96817, United States
Medical Research Partners
Ammon, Idaho, 83406, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640, United States
NorthShore University Health System
Skokie, Illinois, 60077, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50266, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Knownwell
Needham, Massachusetts, 02492, United States
Lucida Clinical Trials
New Bedford, Massachusetts, 02740, United States
Headlands Research - Detroit
Southfield, Michigan, 48034, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Clinvest Headlands Llc
Springfield, Missouri, 65807, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89128, United States
Dent Neurologic Institute
Amherst, New York, 14226, United States
Velocity Clinical Research, Syracuse
East Syracuse, New York, 13057, United States
North Suffolk Neurology
Port Jefferson Station, New York, 11776, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
Medication Management
Greensboro, North Carolina, 27405, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Lucas Research, Inc
Morehead City, North Carolina, 28557, United States
Lucas Research, Inc.
New Bern, North Carolina, 28562, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607, United States
Quality Medical Research
Nashville, Tennessee, 37211, United States
IMA Clinical Research Austin
Austin, Texas, 78745, United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230, United States
FutureSearch Trials of Dallas
Dallas, Texas, 75251, United States
PlanIt Research, PLLC
Houston, Texas, 77079, United States
Endeavor Clinical Trials
San Antonio, Texas, 78240, United States
Tekton Research - Fredericksburg Road
San Antonio, Texas, 78258, United States
Texas Valley Clinical Research
Weslaco, Texas, 78596, United States
Sovah Clinical Research-River District
Danville, Virginia, 24541, United States
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington, 98801, United States
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1056ABI, Argentina
Centro Médico Viamonte
Buenos Aires, C1120AAC, Argentina
Consultorio de Investigación Clínica EMO SRL
Buenos Aires, C1405BUB, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425AGC, Argentina
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2023
First Posted
November 22, 2023
Study Start
November 17, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.