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NCT06143956PHASE2Recruiting

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

Eli Lilly and Company

Start Date

11/17/2023

Completion Date

2/1/2028

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.

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

LY3305677

DRUG

LY3841136

DRUG

Tirzepatide

DRUG

LY3549492

DRUG

LY3532226

DRUG

Placebo

DRUG

Placebo

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Conditions

ObesityOverweight

Locations

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

New Horizon Research Center

Miami, Florida 33165

United States

Indago Research & Health Center, Inc

Miami Lakes, Florida 33016

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

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

Monroe Biomedical Research - Louisville

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

Cicemo Srl

Buenos Aires, 1424

Argentina

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, C1056ABI

Argentina

Centro Médico Viamonte

Buenos Aires, C1120AAC

Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, C1425AGC

Argentina