MedPath

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

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)
Read More
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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
LY3841136 Dose 2 + Tirzepatide Dose 2LY3841136Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136 Dose 3 + Tirzepatide Dose 3LY3841136Participants will receive LY3841136 SC and Tirzepatide SC
Tirzepatide Dose 3TirzepatideParticipants will receive Tirzepatide SC
LY3841136 Dose 2 + Tirzepatide Dose 3LY3841136Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136 Dose 2 + Tirzepatide Dose 3TirzepatideParticipants will receive LY3841136 SC and Tirzepatide SC
PlaceboPlaceboParticipants will receive placebo administered SC.
LY3841136 Dose 1LY3841136Participants will receive LY3841136 subcutaneously (SC)
LY3841136 Dose 2LY3841136Participants will receive LY3841136 SC
LY3841136 Dose 3LY3841136Participants will receive LY3841136 SC
LY3841136 Dose 1 + Tirzepatide Dose 1LY3841136Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136 Dose 1 + Tirzepatide Dose 1TirzepatideParticipants will receive LY3841136 SC and Tirzepatide SC
LY3841136 Dose 2 + Tirzepatide Dose 1LY3841136Participants will receive LY3841136 SC and Tirzepatide SC
LY3841136 Dose 2 + Tirzepatide Dose 1TirzepatideParticipants will receive LY3841136 SC and Tirzepatide SC
LY3841136 Dose 3 + Tirzepatide Dose 3TirzepatideParticipants will receive LY3841136 SC and Tirzepatide SC
LY3841136 Dose 2 + Tirzepatide Dose 2TirzepatideParticipants will receive LY3841136 SC and Tirzepatide SC
Primary Outcome Measures
NameTimeMethod
Percent Change from Baseline in Body WeightBaseline, Week 48
Secondary Outcome Measures
NameTimeMethod
Change from Baseline in Body WeightBaseline, Week 48
Percentage of Participants Who Achieve ≥5% Body Weight ReductionWeek 48
Percentage of Participants Who Achieve ≥10% Body Weight ReductionWeek 48
Change from baseline in Hemoglobin A1c (HbA1c)Baseline, Week 48
Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3841136Baseline, Week 48
PK: Maximum Concentration (Cmax) of LY3841136Baseline, Week 48

Trial Locations

Locations (51)

Diablo Clinical Research, Inc.

🇺🇸

Walnut Creek, California, United States

Centro Médico Viamonte

🇦🇷

Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

🇦🇷

Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)

🇦🇷

Ciudad Autónoma de Buenos Aires, Argentina

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

🇺🇸

Chandler, 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

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

HOPE Research Institute

🇺🇸

Phoenix, Arizona, 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

StudyMetrix Research

🇺🇸

Saint Peters, Missouri, United States

Clinvest Headlands Llc

🇺🇸

Springfield, Missouri, United States

Las Vegas Medical Research

🇺🇸

Las Vegas, Nevada, United States

Dent Neurologic Institute

🇺🇸

Amherst, New York, United States

Velocity Clinical Research, Syracuse

🇺🇸

East Syracuse, New York, United States

North Suffolk Neurology

🇺🇸

Port Jefferson Station, New York, United States

Rochester Clinical Research, LLC

🇺🇸

Rochester, New York, United States

Medication Management

🇺🇸

Greensboro, North Carolina, United States

Monroe Biomedical Research

🇺🇸

Monroe, North Carolina, United States

Lucas Research, Inc

🇺🇸

Morehead City, North Carolina, United States

Lucas Research, Inc.

🇺🇸

New Bern, North Carolina, United States

CTI Clinical Research Center

🇺🇸

Cincinnati, Ohio, United States

Tribe Clinical Research, LLC

🇺🇸

Greenville, South Carolina, United States

Quality Medical Research

🇺🇸

Nashville, Tennessee, United States

IMA Clinical Research Austin

🇺🇸

Austin, Texas, United States

Velocity Clinical Research, Dallas

🇺🇸

Dallas, Texas, United States

FutureSearch Trials of Dallas

🇺🇸

Dallas, Texas, United States

PlanIt Research, PLLC

🇺🇸

Houston, Texas, United States

Tekton Research - Fredericksburg Road

🇺🇸

San Antonio, Texas, United States

Endeavor Clinical Trials

🇺🇸

San Antonio, Texas, United States

Texas Valley Clinical Research

🇺🇸

Weslaco, Texas, United States

Spectrum Medical, Inc.

🇺🇸

Danville, Virginia, United States

Central Washington Health Services Association d/b/a Confluence Health

🇺🇸

Wenatchee, Washington, United States

© Copyright 2025. All Rights Reserved by MedPath