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ACTIVE NOT RECRUITING

NCT06603571

PHASE2

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2024-09-20

Completion Date

2026-08

Last Updated

2025-09-26

Healthy Volunteers

Conditions

Obesity Overweight

Interventions

DRUG

LY3841136

Administered SC

DRUG

Tirzepatide

Administered SC

DRUG

Placebo

Administered SC

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.

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

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

StudyMetrix Research

City of 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

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, Argentina

Centro Médico Viamonte

Buenos Aires, Argentina

Consultorio de Investigación Clínica EMO SRL

Buenos Aires, Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, Argentina

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (52)