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

Recruiting

• Conditions: Obesity; Overweight
• Interventions: Drug: LY3841136; Drug: Tirzepatide; Drug: Placebo

• Registration Number: NCT06603571
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-09-17
• Study First Posted: 2024-09-19
• Study Start: 2024-09-20
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-26
• Last Update Posted: 2025-08-27
• Primary Completion: 2026-06
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

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) 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)

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3841136 Dose 2 + Tirzepatide Dose 2	LY3841136	Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136 Dose 2 + Tirzepatide Dose 3	LY3841136	Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136 Dose 3 + Tirzepatide Dose 3	LY3841136	Participants will receive LY3841136 SC and Tirzepatide SC
Tirzepatide Dose 3	Tirzepatide	Participants will receive Tirzepatide SC
LY3841136 Dose 2 + Tirzepatide Dose 3	Tirzepatide	Participants will receive LY3841136 SC and Tirzepatide SC
Placebo	Placebo	Participants will receive placebo administered SC.
LY3841136 Dose 1	LY3841136	Participants will receive LY3841136 subcutaneously (SC)
LY3841136 Dose 2	LY3841136	Participants will receive LY3841136 SC
LY3841136 Dose 3	LY3841136	Participants will receive LY3841136 SC
LY3841136 Dose 1 + Tirzepatide Dose 1	LY3841136	Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136 Dose 1 + Tirzepatide Dose 1	Tirzepatide	Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136 Dose 2 + Tirzepatide Dose 1	LY3841136	Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136 Dose 2 + Tirzepatide Dose 1	Tirzepatide	Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136 Dose 3 + Tirzepatide Dose 3	Tirzepatide	Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136 Dose 2 + Tirzepatide Dose 2	Tirzepatide	Participants will receive LY3841136 SC and Tirzepatide SC

Primary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Body Weight	Baseline, Week 48

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (52)

The Institute for Liver Health II dba Arizona Clinical Trials - Mesa; 🇺🇸 Chandler, Arizona, United States

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

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