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

Last updated: March 10, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

Placebo

LY3549492

LY3841136

Clinical Study ID

NCT06143956
18685
W8M-MC-LAA2
W8M-MC-GN01
W8M-MC-GN02
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-related 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: 1217
Treatment Group(s): 5
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 17, 2023
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • 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

    Site Not Available

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Buenos Aires, C1425AGC
    Argentina

    Active - Recruiting

  • Centro Médico Viamonte

    Buenos Aires, C1120AAC
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI
    Argentina

    Active - Recruiting

  • Consultorio de Investigación Clínica EMO SRL

    Buenos Aires, C1405BUB
    Argentina

    Active - Recruiting

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Buenos Aires 3435910, C1425AGC
    Argentina

    Active - Recruiting

  • Centro Médico Viamonte

    Buenos Aires 3435910, C1120AAC
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires 3435910, C1056ABI
    Argentina

    Active - Recruiting

  • Consultorio de Investigación Clínica EMO SRL

    Buenos Aires 3435910, C1405BUB
    Argentina

    Site Not Available

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aires, C1056ABI
    Argentina

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

    Chandler, Arizona 85225
    India

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

    Chandler, Arizona 85225
    United States

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    Mesa, Arizona 85210
    United States

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    Phoenix, Arizona 85032
    United States

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  • Hope Research Institute

    Phoenix, Arizona 85018
    United States

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    Scottsdale, Arizona 85260
    United States

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

    Tucson, Arizona 85712
    United States

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

    Chandler 5289282, Arizona 5551752 85225
    United States

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    Phoenix 5308655, Arizona 5551752 85032
    United States

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    Scottsdale 5313457, Arizona 5551752 85260
    United States

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    Tucson 5318313, Arizona 5551752 85712
    United States

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    Greenbrae, California 94904
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    Rolling Hills Estates, California 90274
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    Walnut Creek, California 94598
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    Stamford, Connecticut 06905
    United States

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    Fleming Island, Florida 32003
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    Hialeah, Florida 33012
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    New Port Richey, Florida 34652
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    Fleming Island 4155594, Florida 4155751 32003
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    The Villages 4175179, Florida 4155751 32162
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    Honolulu, Hawaii 96817
    United States

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    Honolulu 5856195, Hawaii 5855797 96817
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    Ammon, Idaho 83406
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    Skokie, Illinois 60077
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    West Des Moines, Iowa 50266
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    Topeka, Kansas 66606
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    Louisville, Kentucky 40213
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    Troy, Michigan 48098
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    City of Saint Peters, Missouri 63303
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    Springfield, Missouri 65807
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    St. Peters, Missouri 63303
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    Las Vegas, Nevada 89128
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    East Syracuse, New York 13057
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  • North Suffolk Neurology

    Port Jefferson Station, New York 11776
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  • Rochester Clinical Research, LLC

    Rochester, New York 14609
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  • Dent Neurologic Institute

    Amherst 5107129, New York 5128638 14226
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  • Velocity Clinical Research, Syracuse

    East Syracuse 5116079, New York 5128638 13057
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    Port Jefferson Station 5132015, New York 5128638 11776
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    Rochester 5134086, New York 5128638 14609
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    Morehead City, North Carolina 28557
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    New Bern, North Carolina 28562
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    New Bern, North Carolina 28562
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    Greensboro 4469146, North Carolina 4482348 27405
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    New Bern 4481682, North Carolina 4482348 28562
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    Greenville, South Carolina 29607
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    Greenville 4580543, South Carolina 4597040 29607
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    Nashville, Tennessee 37211
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    Nashville 4644585, Tennessee 4662168 37211
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    Austin, Texas 78745
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  • Dallas Diabetes Research Center

    Dallas, Texas 75230
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  • FutureSearch Trials of Dallas

    Dallas, Texas 75251
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    Dallas, Texas 75230
    United States

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    Houston, Texas 77079
    United States

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  • PlanIt Research, PLLC

    Houston, Texas 77079
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  • Endeavor Clinical Trials

    San Antonio, Texas 78240
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  • Tekton Research - Fredericksburg Road

    San Antonio, Texas 78229
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  • Texas Valley Clinical Research

    Weslaco, Texas 78596
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    Austin 4671654, Texas 4736286 78745
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  • FutureSearch Trials of Dallas

    Dallas 4684888, Texas 4736286 75251
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  • Velocity Clinical Research, Dallas

    Dallas 4684888, Texas 4736286 75230
    United States

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  • PlanIt Research, PLLC

    Houston 4699066, Texas 4736286 77079
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  • Endeavor Clinical Trials

    San Antonio 4726206, Texas 4736286 78240
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  • Tekton Research - Fredericksburg Road

    San Antonio 4726206, Texas 4736286 78229
    United States

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    Weslaco 4740629, Texas 4736286 78596
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    Danville, Virginia 24541
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    Danville, Virginia 24541
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    Danville 4755280, Virginia 6254928 24541
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    Danville 4755280, Virginia 6254928 24541
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  • Central Washington Health Services Association d/b/a Confluence Health

    Wenatchee, Washington 98801
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  • Central Washington Health Services Association d/b/a Confluence Health

    Wenatchee 5815342, Washington 5815135 98801
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