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

Last updated: April 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

LY3549492

LY3841136

Placebo

Clinical Study ID

NCT06143956
18685
W8M-MC-LAA2
W8M-MC-GN01
W8M-MC-OXA1
W8M-MC-LAA1
W8M-MC-CWMM
  • Ages 18-75
  • All Genders

Study 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

Inclusion

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-releated comorbidity

  • Have had a stable body weight for the 3 months prior to randomization (<5%) bodyweight gain and/or loss.

Exclusion

Exclusion Criteria:

  • Have a prior or planned surgical treatment for obesity, except prior liposuction orabdominoplasty, if performed >1 year prior to screening.

  • Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history ofketoacidosis or hyperosmolar coma.

  • Have poorly controlled hypertension.

  • Have signs and symptoms of any liver disease other than nonalcoholic fatty liverdisease.

  • Have any of the following cardiovascular conditions within 3 months prior toscreening:

  • 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.

Study Design

Total Participants: 1040
Treatment Group(s): 5
Primary Treatment: LY3549492
Phase: 2
Study Start date:
November 17, 2023
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Centro Médico Viamonte

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1120AAC
    Argentina

    Active - Recruiting

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires C1425AGC
    Argentina

    Active - Recruiting

  • Consultorio de Investigación Clínica EMO SRL

    Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires C1405BUB
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aires, C1056ABI
    Argentina

    Active - Recruiting

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

    Chandler, Arizona 85225
    India

    Active - Recruiting

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

    Chandler, Arizona 85225
    United States

    Active - Recruiting

  • The Institute for Liver Health dba Arizona Clinical Trials

    Mesa, Arizona 85210
    United States

    Site Not Available

  • HOPE Research Institute

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • Hope Research Institute

    Phoenix, Arizona 85018
    United States

    Active - Recruiting

  • Headlands Research - Scottsdale

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

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

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • NorCal Medical Research, Inc

    Greenbrae, California 94904
    United States

    Active - Recruiting

  • National Research Institute - Huntington Park

    Huntington Park, California 90255
    United States

    Active - Recruiting

  • Velocity Clinical Research, Huntington Park

    Huntington Park, California 90255
    United States

    Active - Recruiting

  • Peninsula Research Associates

    Rolling Hills Estates, California 90274
    United States

    Active - Recruiting

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Stamford Therapeutics Consortium

    Stamford, Connecticut 06905
    United States

    Active - Recruiting

  • Northeast Research Institute (NERI)

    Fleming Island, Florida 32003
    United States

    Active - Recruiting

  • Indago Research & Health Center, Inc

    Hialeah, Florida 33012
    United States

    Active - Recruiting

  • New Horizon Research Center

    Miami, Florida 33165
    United States

    Active - Recruiting

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida 34652
    United States

    Active - Recruiting

  • Charter Research - Winter Park

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Charter Research - Lady Lake

    The Villages, Florida 32162
    United States

    Active - Recruiting

  • Charter Research - Winter Park

    Winter Park, Florida 32803
    United States

    Site Not Available

  • Pacific Diabetes & Endocrine Center

    Honolulu, Hawaii 96817
    United States

    Active - Recruiting

  • Medical Research Partners

    Ammon, Idaho 83406
    United States

    Active - Recruiting

  • Great Lakes Clinical Trials - Andersonville

    Chicago, Illinois 60640
    United States

    Active - Recruiting

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois 60640
    United States

    Active - Recruiting

  • NorthShore University Health System

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa 50266
    United States

    Active - Recruiting

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • L-MARC Research Center

    Louisville, Kentucky 40213
    United States

    Active - Recruiting

  • Knownwell

    Needham, Massachusetts 02492
    United States

    Active - Recruiting

  • Lucida Clinical Trials

    New Bedford, Massachusetts 02740
    United States

    Active - Recruiting

  • Headlands Research - Detroit

    Southfield, Michigan 48034
    United States

    Active - Recruiting

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan 48098
    United States

    Active - Recruiting

  • StudyMetrix Research

    Saint Peters, Missouri 63303
    United States

    Active - Recruiting

  • Clinvest Headlands Llc

    Springfield, Missouri 65807
    United States

    Active - Recruiting

  • Clinvest Research LLC

    Springfield, Missouri 65807
    United States

    Active - Recruiting

  • Las Vegas Medical Research

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

  • Dent Neurologic Institute

    Amherst, New York 14226
    United States

    Active - Recruiting

  • Clarity Clinical Research

    East Syracuse, New York 13057
    United States

    Active - Recruiting

  • Velocity Clinical Research, Syracuse

    East Syracuse, New York 13057
    United States

    Active - Recruiting

  • North Suffolk Neurology

    Port Jefferson Station, New York 11776
    United States

    Active - Recruiting

  • Rochester Clinical Research, LLC

    Rochester, New York 14609
    United States

    Active - Recruiting

  • Medication Management

    Greensboro, North Carolina 27405
    United States

    Active - Recruiting

  • Monroe Biomedical Research

    Monroe, North Carolina 28112
    United States

    Active - Recruiting

  • Lucas Research, Inc

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • Lucas Research - New Bern

    New Bern, North Carolina 28562
    United States

    Active - Recruiting

  • Lucas Research, Inc.

    New Bern, North Carolina 28562
    United States

    Active - Recruiting

  • CTI Clinical Research Center

    Cincinnati, Ohio 45212
    United States

    Active - Recruiting

  • CTI-CRC

    Cincinnati, Ohio 45212
    United States

    Active - Recruiting

  • Tribe Clinical Research, LLC

    Greenville, South Carolina 29607
    United States

    Active - Recruiting

  • Quality Medical Research

    Nashville, Tennessee 37211
    United States

    Active - Recruiting

  • IMA Clinical Research Austin

    Austin, Texas 78745
    United States

    Active - Recruiting

  • Dallas Diabetes Research Center

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • FutureSearch Trials of Dallas

    Dallas, Texas 75251
    United States

    Active - Recruiting

  • Velocity Clinical Research, Dallas

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Endocrine Ips, Pllc

    Houston, Texas 77079
    United States

    Active - Recruiting

  • PlanIt Research, PLLC

    Houston, Texas 77079
    United States

    Active - Recruiting

  • Endeavor Clinical Trials

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Tekton Research - Fredericksburg Road

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Texas Valley Clinical Research

    Weslaco, Texas 78596
    United States

    Active - Recruiting

  • Spectrum Medical, Inc.

    Danville, Virginia 24541
    United States

    Active - Recruiting

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

    Wenatchee, Washington 98801
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.