A Study to Investigate Weight Management With LY3841136 and Tirzepatide (LY3298176), Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes

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

Phase

2

Condition

Diabetes Prevention

Obesity

Hypertriglyceridemia

Treatment

Placebo

LY3841136

Tirzepatide

Clinical Study ID

NCT06603571
18809
W8M-MC-LAA2
W8M-MC-CWMM Master Protocol
  • Ages 18-75
  • All Genders

Study Summary

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate the safety and efficacy of LY3841136 for chronic weight management alone or in combination with Tirzepatide across a wide dose range in participants with Type 2 Diabetes. Participation in the study will last about 64 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

W8M-MC-LAA2

  • Have a Body Mass Index (BMI) of ≥27 kilograms per square meter (kg/m²)

  • Have Type 2 Diabetes

  • Have a HbA1c ≥7.0 % (53 millimoles/mole (mmol/mol)) to ≤10.5% (91 mmol/mol) andtreated with diet and exercise alone or with a stable dose of metformin (and notmore than the locally approved dose) with or without a sodium-glucose cotransporter 2 (SGLT2) inhibitor for at least 3 months prior to screening

W8M-MC-CWMM:

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

Exclusion

Exclusion Criteria:

W8M-MC-LAA2

  • Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6months prior to screening

  • Have an on-going or history of bradyarrhythmia and/or sinus bradycardia

  • Have an elevated resting pulse rate (mean >100 beats per minute (bpm)) or reducedresting pulse rate (mean <60 bpm) at screening

  • Have any of the following cardiovascular conditions within 6 months prior toscreening:

  • acute myocardial infarction

  • cerebrovascular accident (stroke)

  • unstable angina, or

  • hospitalization due to congestive heart failure

  • Have renal impairment measured as estimated glomerular filtration rate (eGFR) <45milliliters per minute (mL/min)/1.73 m2

  • Have a history of acute or chronic pancreatitis

  • Have fasting triglycerides >500 milligrams per deciliter (mg/dL) (5.7 mmol/L) atscreening

  • All concomitant medications should be at a stable dose for at least 3 months priorto screening

W8M-MC-CWMM

  • 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 a history of symptomatic gallbladder disease within the past 2 years

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

  • Have a lifetime history of suicide attempts.

Study Design

Total Participants: 350
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 2
Study Start date:
September 20, 2024
Estimated Completion Date:
August 31, 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
    United States

    Active - Recruiting

  • 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

  • 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

  • Diablo Clinical Research, Inc. Loc. 4

    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

  • 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 Diabetes & Endocrinology

    Topeka, Kansas 66606
    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

  • Las Vegas Medical Research

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

  • Dent Neurologic Institute

    Amherst, New York 14226
    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, Inc.

    New Bern, North Carolina 28562
    United States

    Active - Recruiting

  • CTI Clinical Research Center

    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

  • FutureSearch Trials of Dallas

    Dallas, Texas 75251
    United States

    Active - Recruiting

  • Velocity Clinical Research, Dallas

    Dallas, Texas 75230
    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

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