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

NCT06603571 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: 18809W8M-MC-LAA2W8M-MC-CWMM Master Protocol
• Study Type: interventional
• Target: 350
• Locations: 2 countries
• Sites: 52

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.

Conditions

Obesity; Overweight

Keywords

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Percent Change from Baseline in Body Weight

  Baseline, Week 48

Secondary Outcomes (6)

• 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

Study Arms (10)

LY3841136 Dose 1

EXPERIMENTAL

Participants will receive LY3841136 subcutaneously (SC)

Drug: LY3841136

LY3841136 Dose 2

EXPERIMENTAL

Participants will receive LY3841136 SC

Drug: LY3841136

LY3841136 Dose 3

EXPERIMENTAL

Participants will receive LY3841136 SC

Drug: LY3841136

LY3841136 Dose 1 + Tirzepatide Dose 1

EXPERIMENTAL

Participants will receive LY3841136 SC and Tirzepatide SC

Drug: LY3841136; Drug: Tirzepatide

LY3841136 Dose 2 + Tirzepatide Dose 1

EXPERIMENTAL

Participants will receive LY3841136 SC and Tirzepatide SC

Drug: LY3841136; Drug: Tirzepatide

LY3841136 Dose 2 + Tirzepatide Dose 2

EXPERIMENTAL

Participants will receive LY3841136 SC and Tirzepatide SC

Drug: LY3841136; Drug: Tirzepatide

LY3841136 Dose 3 + Tirzepatide Dose 3

EXPERIMENTAL

Participants will receive LY3841136 SC and Tirzepatide SC

Drug: LY3841136; Drug: Tirzepatide

Tirzepatide Dose 3

ACTIVE COMPARATOR

Participants will receive Tirzepatide SC

Drug: Tirzepatide

LY3841136 Dose 2 + Tirzepatide Dose 3

EXPERIMENTAL

Participants will receive LY3841136 SC and Tirzepatide SC

Drug: LY3841136; Drug: Tirzepatide

Placebo

PLACEBO COMPARATOR

Participants will receive placebo administered SC.

Drug: Placebo

Interventions

LY3841136 DRUG

Administered SC

LY3841136 Dose 1; LY3841136 Dose 1 + Tirzepatide Dose 1; LY3841136 Dose 2; LY3841136 Dose 2 + Tirzepatide Dose 1; LY3841136 Dose 2 + Tirzepatide Dose 2; LY3841136 Dose 2 + Tirzepatide Dose 3; LY3841136 Dose 3; LY3841136 Dose 3 + Tirzepatide Dose 3

Tirzepatide DRUG

Administered SC

LY3841136 Dose 1 + Tirzepatide Dose 1; LY3841136 Dose 2 + Tirzepatide Dose 1; LY3841136 Dose 2 + Tirzepatide Dose 2; LY3841136 Dose 2 + Tirzepatide Dose 3; LY3841136 Dose 3 + Tirzepatide Dose 3; Tirzepatide Dose 3

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (52)

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

Chandler, Arizona, 85225, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85032, United States

Location

Headlands Research - Scottsdale

Scottsdale, Arizona, 85260, United States

Location

The Institute for Liver Health II dba Arizona Liver Health-Tucson

Tucson, Arizona, 85712, United States

Location

NorCal Medical Research, Inc

Greenbrae, California, 94904, United States

Location

Velocity Clinical Research, Huntington Park

Huntington Park, California, 90255, United States

Location

Peninsula Research Associates

Rolling Hills Estates, California, 90274, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States

Location

Northeast Research Institute (NERI)

Fleming Island, Florida, 32003, United States

Location

Indago Research & Health Center, Inc

Hialeah, Florida, 33012, United States

Location

New Horizon Research Center

Miami, Florida, 33165, United States

Location

Suncoast Clinical Research, Inc.

New Port Richey, Florida, 34652, United States

Location

Charter Research - Winter Park

Orlando, Florida, 32803, United States

Location

Charter Research - Lady Lake

The Villages, Florida, 32162, United States

Location

Medical Research Partners

Ammon, Idaho, 83406, United States

Location

Great Lakes Clinical Trials - Andersonville

Chicago, Illinois, 60640, United States

Location

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, 60640, United States

Location

NorthShore University Health System

Skokie, Illinois, 60077, United States

Location

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, 50266, United States

Location

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, 66606, United States

Location

Knownwell

Needham, Massachusetts, 02492, United States

Location

Lucida Clinical Trials

New Bedford, Massachusetts, 02740, United States

Location

Headlands Research - Detroit

Southfield, Michigan, 48034, United States

Location

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, 48098, United States

Location

StudyMetrix Research

City of Saint Peters, Missouri, 63303, United States

Location

Clinvest Headlands Llc

Springfield, Missouri, 65807, United States

Location

Las Vegas Medical Research

Las Vegas, Nevada, 89128, United States

Location

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

Velocity Clinical Research, Syracuse

East Syracuse, New York, 13057, United States

Location

North Suffolk Neurology

Port Jefferson Station, New York, 11776, United States

Location

Rochester Clinical Research, LLC

Rochester, New York, 14609, United States

Location

Medication Management

Greensboro, North Carolina, 27405, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

Lucas Research, Inc

Morehead City, North Carolina, 28557, United States

Location

Lucas Research, Inc.

New Bern, North Carolina, 28562, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Tribe Clinical Research, LLC

Greenville, South Carolina, 29607, United States

Location

Quality Medical Research

Nashville, Tennessee, 37211, United States

Location

IMA Clinical Research Austin

Austin, Texas, 78745, United States

Location

Velocity Clinical Research, Dallas

Dallas, Texas, 75230, United States

Location

FutureSearch Trials of Dallas

Dallas, Texas, 75251, United States

Location

PlanIt Research, PLLC

Houston, Texas, 77079, United States

Location

Tekton Research - Fredericksburg Road

San Antonio, Texas, 78229, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78240, United States

Location

Texas Valley Clinical Research

Weslaco, Texas, 78596, United States

Location

Spectrum Medical, Inc.

Danville, Virginia, 24541, United States

Location

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

Wenatchee, Washington, 98801, United States

Location

Centro de Investigaciones Metabólicas (CINME)

Buenos Aires, C1056ABI, Argentina

Location

Centro Médico Viamonte

Buenos Aires, C1120AAC, Argentina

Location

Consultorio de Investigación Clínica EMO SRL

Buenos Aires, C1405BUB, Argentina

Location

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, C1425AGC, Argentina

Location

Related Links

• 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

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus, Type 2

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

US (48); AR (4)