Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY3841136 Dose 1
Participants will receive LY3841136 subcutaneously (SC)
  • Drug: LY3841136
    Administered SC
Experimental
LY3841136 Dose 2
Participants will receive LY3841136 SC
  • Drug: LY3841136
    Administered SC
Experimental
LY3841136 Dose 3
Participants will receive LY3841136 SC
  • Drug: LY3841136
    Administered SC
Experimental
LY3841136 Dose 1 + Tirzepatide Dose 1
Participants will receive LY3841136 SC and Tirzepatide SC
  • Drug: LY3841136
    Administered SC
  • Drug: Tirzepatide
    Administered SC
Experimental
LY3841136 Dose 2 + Tirzepatide Dose 1
Participants will receive LY3841136 SC and Tirzepatide SC
  • Drug: LY3841136
    Administered SC
  • Drug: Tirzepatide
    Administered SC
Experimental
LY3841136 Dose 2 + Tirzepatide Dose 2
Participants will receive LY3841136 SC and Tirzepatide SC
  • Drug: LY3841136
    Administered SC
  • Drug: Tirzepatide
    Administered SC
Experimental
LY3841136 Dose 3 + Tirzepatide Dose 3
Participants will receive LY3841136 SC and Tirzepatide SC
  • Drug: LY3841136
    Administered SC
  • Drug: Tirzepatide
    Administered SC
Active Comparator
Tirzepatide Dose 3
Participants will receive Tirzepatide SC
  • Drug: Tirzepatide
    Administered SC
Experimental
LY3841136 Dose 2 + Tirzepatide Dose 3
Participants will receive LY3841136 SC and Tirzepatide SC
  • Drug: LY3841136
    Administered SC
  • Drug: Tirzepatide
    Administered SC
Placebo Comparator
Placebo
Participants will receive placebo administered SC.
  • Drug: Placebo
    Administered SC

Recruiting Locations

The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona 85225

HOPE Research Institute
Phoenix, Arizona 85032

Headlands Research - Scottsdale
Scottsdale, Arizona 85260

The Institute for Liver Health II dba Arizona Liver Health-Tucson
Tucson, Arizona 85712

NorCal Medical Research, Inc
Greenbrae, California 94904

Velocity Clinical Research, Huntington Park
Huntington Park, California 90255

Peninsula Research Associates
Rolling Hills Estates, California 90274

Diablo Clinical Research, Inc.
Walnut Creek, California 94598

Stamford Therapeutics Consortium
Stamford, Connecticut 06905

Northeast Research Institute (NERI)
Fleming Island, Florida 32003

Indago Research & Health Center, Inc
Hialeah, Florida 33012

New Horizon Research Center
Miami, Florida 33165

Suncoast Clinical Research, Inc.
New Port Richey, Florida 34652

Charter Research - Winter Park
Orlando, Florida 32803

Charter Research - Lady Lake
The Villages, Florida 32162

Medical Research Partners
Ammon, Idaho 83406

Great Lakes Clinical Trials - Andersonville
Chicago, Illinois 60640

Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois 60640

NorthShore University Health System
Skokie, Illinois 60077

Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa 50266

Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas 66606

Knownwell
Needham, Massachusetts 02492

Lucida Clinical Trials
New Bedford, Massachusetts 02740

Headlands Research - Detroit
Southfield, Michigan 48034

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan 48098

StudyMetrix Research
Saint Peters, Missouri 63303

Clinvest Headlands Llc
Springfield, Missouri 65807

Las Vegas Medical Research
Las Vegas, Nevada 89128

Dent Neurologic Institute
Amherst, New York 14226

Velocity Clinical Research, Syracuse
East Syracuse, New York 13057

North Suffolk Neurology
Port Jefferson Station, New York 11776

Rochester Clinical Research, LLC
Rochester, New York 14609

Medication Management
Greensboro, North Carolina 27405

Monroe Biomedical Research
Monroe, North Carolina 28112

Lucas Research, Inc
Morehead City, North Carolina 28557

Lucas Research, Inc.
New Bern, North Carolina 28562

CTI Clinical Research Center
Cincinnati, Ohio 45212

Tribe Clinical Research, LLC
Greenville, South Carolina 29607

Quality Medical Research
Nashville, Tennessee 37211

IMA Clinical Research Austin
Austin, Texas 78745

Velocity Clinical Research, Dallas
Dallas, Texas 75230

FutureSearch Trials of Dallas
Dallas, Texas 75251

PlanIt Research, PLLC
Houston, Texas 77079

Tekton Research - Fredericksburg Road
San Antonio, Texas 78229

Endeavor Clinical Trials
San Antonio, Texas 78240

Texas Valley Clinical Research
Weslaco, Texas 78596

Spectrum Medical, Inc.
Danville, Virginia 24541

Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington 98801

More Details

NCT ID
NCT06603571
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
clinical_inquiry_hub@lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.