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A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight

NCT ID: NCT06143956

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

1217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-17

Study Completion Date

2026-09-30

Brief Summary

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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

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Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The CWMM protocol includes screening assessments plus a framework for the subsequent intervention, which is the primary purpose of the protocol.
Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3305677 Obesity ISA OXA1

Participants will receive LY3305677 or placebo subcutaneously (SC).

Each ISA will detail the intervention specific analysis.

Group Type EXPERIMENTAL

LY3305677

Intervention Type DRUG

Administered SC. ISA specific interventions will be listed in the ISA.

Placebo

Intervention Type DRUG

Administered SC. ISA specific interventions will be listed in the ISA.

LY3841136 Obesity ISA LAA1

Participants will receive LY3841136 or placebo SC.

Each ISA will detail the intervention specific analysis.

Group Type EXPERIMENTAL

LY3841136

Intervention Type DRUG

Administered SC. ISA specific interventions will be listed in the ISA.

Placebo

Intervention Type DRUG

Administered SC. ISA specific interventions will be listed in the ISA.

LY3841136 Obesity ISA LAA2

Participants will receive LY3841136, tirzepatide and placebo SC.

Each ISA will detail the intervention specific analysis.

Group Type EXPERIMENTAL

LY3841136

Intervention Type DRUG

Administered SC. ISA specific interventions will be listed in the ISA.

Tirzepatide

Intervention Type DRUG

Administered SC. ISA specific interventions will be listed in the ISA.

Placebo

Intervention Type DRUG

Administered SC. ISA specific interventions will be listed in the ISA.

LY3549492 Obesity ISA GN01

Participants will receive LY3549492 orally.

Each ISA will detail the intervention specific analysis.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Administered SC. ISA specific interventions will be listed in the ISA.

LY3549492

Intervention Type DRUG

Administered orally. ISA specific interventions will be listed in the ISA.

LY3549492 Obesity ISA GN02

Participants will receive LY3549492 or placebo orally.

Each ISA will detail the intervention specific analysis.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Administered SC. ISA specific interventions will be listed in the ISA.

LY3549492

Intervention Type DRUG

Administered orally. ISA specific interventions will be listed in the ISA.

Interventions

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LY3305677

Administered SC. ISA specific interventions will be listed in the ISA.

Intervention Type DRUG

LY3841136

Administered SC. ISA specific interventions will be listed in the ISA.

Intervention Type DRUG

Tirzepatide

Administered SC. ISA specific interventions will be listed in the ISA.

Intervention Type DRUG

Placebo

Administered SC. ISA specific interventions will be listed in the ISA.

Intervention Type DRUG

LY3549492

Administered orally. ISA specific interventions will be listed in the ISA.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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The Institute for Liver Health II dba Arizona Clinical Trials - Mesa

Chandler, Arizona, United States

Site Status RECRUITING

HOPE Research Institute

Phoenix, Arizona, United States

Site Status RECRUITING

Headlands Research - Scottsdale

Scottsdale, Arizona, United States

Site Status RECRUITING

The Institute for Liver Health II dba Arizona Liver Health-Tucson

Tucson, Arizona, United States

Site Status RECRUITING

NorCal Medical Research, Inc

Greenbrae, California, United States

Site Status RECRUITING

Velocity Clinical Research, Huntington Park

Huntington Park, California, United States

Site Status RECRUITING

Peninsula Research Associates

Rolling Hills Estates, California, United States

Site Status RECRUITING

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status RECRUITING

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Site Status RECRUITING

Northeast Research Institute (NERI)

Fleming Island, Florida, United States

Site Status RECRUITING

Indago Research & Health Center, Inc

Hialeah, Florida, United States

Site Status RECRUITING

New Horizon Research Center

Miami, Florida, United States

Site Status RECRUITING

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Site Status RECRUITING

Charter Research - Winter Park

Orlando, Florida, United States

Site Status RECRUITING

Charter Research - Lady Lake

The Villages, Florida, United States

Site Status RECRUITING

Pacific Diabetes & Endocrine Center

Honolulu, Hawaii, United States

Site Status RECRUITING

Medical Research Partners

Ammon, Idaho, United States

Site Status RECRUITING

Great Lakes Clinical Trials - Andersonville

Chicago, Illinois, United States

Site Status RECRUITING

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, United States

Site Status RECRUITING

NorthShore University Health System

Skokie, Illinois, United States

Site Status RECRUITING

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Site Status RECRUITING

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, United States

Site Status RECRUITING

L-MARC Research Center

Louisville, Kentucky, United States

Site Status RECRUITING

Knownwell

Needham, Massachusetts, United States

Site Status RECRUITING

Lucida Clinical Trials

New Bedford, Massachusetts, United States

Site Status RECRUITING

Headlands Research - Detroit

Southfield, Michigan, United States

Site Status RECRUITING

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, United States

Site Status RECRUITING

StudyMetrix Research

City of Saint Peters, Missouri, United States

Site Status RECRUITING

Clinvest Headlands Llc

Springfield, Missouri, United States

Site Status RECRUITING

Las Vegas Medical Research

Las Vegas, Nevada, United States

Site Status RECRUITING

Dent Neurologic Institute

Amherst, New York, United States

Site Status RECRUITING

Velocity Clinical Research, Syracuse

East Syracuse, New York, United States

Site Status RECRUITING

North Suffolk Neurology

Port Jefferson Station, New York, United States

Site Status RECRUITING

Rochester Clinical Research, LLC

Rochester, New York, United States

Site Status RECRUITING

Medication Management

Greensboro, North Carolina, United States

Site Status RECRUITING

Monroe Biomedical Research

Monroe, North Carolina, United States

Site Status RECRUITING

Lucas Research, Inc

Morehead City, North Carolina, United States

Site Status RECRUITING

Lucas Research, Inc.

New Bern, North Carolina, United States

Site Status RECRUITING

CTI Clinical Research Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Tribe Clinical Research, LLC

Greenville, South Carolina, United States

Site Status RECRUITING

Quality Medical Research

Nashville, Tennessee, United States

Site Status RECRUITING

IMA Clinical Research Austin

Austin, Texas, United States

Site Status RECRUITING

Velocity Clinical Research, Dallas

Dallas, Texas, United States

Site Status RECRUITING

FutureSearch Trials of Dallas

Dallas, Texas, United States

Site Status RECRUITING

PlanIt Research, PLLC

Houston, Texas, United States

Site Status RECRUITING

Tekton Research - Fredericksburg Road

San Antonio, Texas, United States

Site Status RECRUITING

Endeavor Clinical Trials

San Antonio, Texas, United States

Site Status RECRUITING

Texas Valley Clinical Research

Weslaco, Texas, United States

Site Status RECRUITING

Sovah Clinical Research-River District

Danville, Virginia, United States

Site Status RECRUITING

Central Washington Health Services Association d/b/a Confluence Health

Wenatchee, Washington, United States

Site Status RECRUITING

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, , Argentina

Site Status RECRUITING

Centro Médico Viamonte

Buenos Aires, , Argentina

Site Status RECRUITING

Consultorio de Investigación Clínica EMO SRL

Buenos Aires, , Argentina

Site Status RECRUITING

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, , Argentina

Site Status RECRUITING

Countries

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India United States Argentina

Central Contacts

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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Role: CONTACT

Phone: 1-317-615-4559

Email: [email protected]

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Email: [email protected]

Facility Contacts

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Other Identifiers

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W8M-MC-CWMM

Identifier Type: OTHER

Identifier Source: secondary_id

W8M-MC-OXA1

Identifier Type: OTHER

Identifier Source: secondary_id

W8M-MC-LAA1

Identifier Type: OTHER

Identifier Source: secondary_id

W8M-MC-LAA2

Identifier Type: OTHER

Identifier Source: secondary_id

W8M-MC-GN01

Identifier Type: OTHER

Identifier Source: secondary_id

W8M-MC-GN02

Identifier Type: OTHER

Identifier Source: secondary_id

18685

Identifier Type: -

Identifier Source: org_study_id