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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 Phase 2 350 Master Protocol

Active, not recruiting
Clinical Trial NCT06603571 is designed to study Treatment for Obesity, Overweight. It is a Phase 2 interventional study that is active, not recruiting, having started on September 20, 2024, with plans to enroll 350 participants. Led by Eli Lilly and Company, it is expected to complete by August 1, 2026. The latest data from ClinicalTrials.gov was last updated on September 26, 2025.
Brief 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.
Official Title

A Phase 2, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Management With LY3841136 and Tirzepatide, Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes

Conditions
ObesityOverweight
Other Study IDs
  • 18809
  • W8M-MC-LAA2 (Other Identifier) (Eli Lilly and Company)
  • W8M-MC-CWMM Master Protocol (Other Identifier) (Eli Lilly and Company)
NCT ID Number
Start Date (Actual)
2024-09-20
Last Update Posted
2025-09-26
Completion Date (Estimated)
2026-08
Enrollment (Estimated)
350
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Keywords
Type 2 Diabetes
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalLY3841136 Dose 1
Participants will receive LY3841136 subcutaneously (SC)
LY3841136
Administered SC
ExperimentalLY3841136 Dose 2
Participants will receive LY3841136 SC
LY3841136
Administered SC
ExperimentalLY3841136 Dose 3
Participants will receive LY3841136 SC
LY3841136
Administered SC
ExperimentalLY3841136 Dose 1 + Tirzepatide Dose 1
Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136
Administered SC
Tirzepatide
Administered SC
ExperimentalLY3841136 Dose 2 + Tirzepatide Dose 1
Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136
Administered SC
Tirzepatide
Administered SC
ExperimentalLY3841136 Dose 2 + Tirzepatide Dose 2
Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136
Administered SC
Tirzepatide
Administered SC
ExperimentalLY3841136 Dose 3 + Tirzepatide Dose 3
Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136
Administered SC
Tirzepatide
Administered SC
Active ComparatorTirzepatide Dose 3
Participants will receive Tirzepatide SC
Tirzepatide
Administered SC
ExperimentalLY3841136 Dose 2 + Tirzepatide Dose 3
Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136
Administered SC
Tirzepatide
Administered SC
Placebo ComparatorPlacebo
Participants will receive placebo administered SC.
Placebo
Administered SC
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Percent Change from Baseline in Body Weight
Baseline, Week 48
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change from Baseline in Body Weight
Baseline, Week 48
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Week 48
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Week 48
Change from baseline in Hemoglobin A1c (HbA1c)
Baseline, Week 48
Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3841136
Baseline, Week 48
PK: Maximum Concentration (Cmax) of LY3841136
Baseline, Week 48
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

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) and treated with diet and exercise alone or with a stable dose of metformin (and not more 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% body weight gain and/or loss)

W8M-MC-LAA2

  • Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months 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 reduced resting pulse rate (mean <60 bpm) at screening

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

    • 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) <45 milliliters 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) at screening

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

W8M-MC-CWMM

  • 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 a history of symptomatic gallbladder disease within the past 2 years
  • Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
  • Have a lifetime history of suicide attempts.
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52 Study Locations in 2 Countries

Arizona

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

California

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

Connecticut

Stamford Therapeutics Consortium, Stamford, Connecticut, 06905, United States

Florida

Northeast Research Institute (NERI), Fleming Island, Florida, 32003, United States
Indago Research & Health Center, Inc, Hialeah, Florida, 33012, United States
New Horizon Research Center, Miami, Florida, 33165, 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

Idaho

Medical Research Partners, Ammon, Idaho, 83406, United States

Illinois

Great Lakes Clinical Trials - Andersonville, 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

Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50266, United States

Kansas

Cotton O'Neil Diabetes & Endocrinology, Topeka, Kansas, 66606, United States

Massachusetts

Knownwell, Needham, Massachusetts, 02492, United States
Lucida Clinical Trials, New Bedford, Massachusetts, 02740, United States

Michigan

Headlands Research - Detroit, Southfield, Michigan, 48034, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division, Troy, Michigan, 48098, United States

Missouri

StudyMetrix Research, City of Saint Peters, Missouri, 63303, United States
Clinvest Headlands Llc, Springfield, Missouri, 65807, United States

Nevada

Las Vegas Medical Research, Las Vegas, Nevada, 89128, United States

New York

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

North Carolina

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

Ohio

CTI Clinical Research Center, Cincinnati, Ohio, 45212, United States

South Carolina

Tribe Clinical Research, LLC, Greenville, South Carolina, 29607, United States

Tennessee

Quality Medical Research, Nashville, Tennessee, 37211, United States

Texas

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
Tekton Research - Fredericksburg Road, San Antonio, Texas, 78229, United States
Endeavor Clinical Trials, San Antonio, Texas, 78240, United States
Texas Valley Clinical Research, Weslaco, Texas, 78596, United States

Virginia

Spectrum Medical, Inc., Danville, Virginia, 24541, United States

Washington

Central Washington Health Services Association d/b/a Confluence Health, Wenatchee, Washington, 98801, United States
Centro de Investigaciones Metabólicas (CINME), Buenos Aires, C1056ABI, Argentina
Centro Médico Viamonte, Buenos Aires, C1120AAC, Argentina
Consultorio de Investigación Clínica EMO SRL, Buenos Aires, C1405BUB, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada, Buenos Aires, C1425AGC, Argentina