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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Obesity, Overweight

In brief

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.

Key facts

Study ID

NCT06603571

Run by

Eli Lilly and Company

People needed

367

Starts

2024-09-20

Expected to finish

2026-08-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• HOPE Research Institute — Phoenix, Arizona, United States
• Headlands Research - Scottsdale — Scottsdale, Arizona, United States
• The Institute for Liver Health II dba Arizona Liver Health-Tucson — Tucson, Arizona, United States
• NorCal Medical Research, Inc — Greenbrae, California, United States
• Velocity Clinical Research, Huntington Park — Huntington Park, California, United States
• Peninsula Research Associates — Rolling Hills Estates, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Northeast Research Institute (NERI) — Fleming Island, Florida, United States
• Indago Research & Health Center, Inc — Hialeah, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• Suncoast Clinical Research, Inc. — New Port Richey, Florida, United States
• Charter Research - Winter Park — Orlando, Florida, United States
• Charter Research - Lady Lake — The Villages, Florida, United States
• Medical Research Partners — Ammon, Idaho, United States
• Great Lakes Clinical Trials - Andersonville — Chicago, Illinois, United States
• Great Lakes Clinical Trials - Ravenswood — Chicago, Illinois, United States
• NorthShore University Health System — Skokie, Illinois, United States
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
• Cotton O'Neil Diabetes & Endocrinology — Topeka, Kansas, United States
• Knownwell — Needham, Massachusetts, United States
• Lucida Clinical Trials — New Bedford, Massachusetts, United States
• Headlands Research - Detroit — Southfield, Michigan, United States
• Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy, Michigan, United States
• The Institute for Liver Health II dba Arizona Clinical Trials - Mesa — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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