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
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
- Obesity
- Overweight
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
Arm | Description | Assigned Intervention |
---|---|---|
Experimental LY3841136 Dose 1 |
Participants will receive LY3841136 subcutaneously (SC) |
|
Experimental LY3841136 Dose 2 |
Participants will receive LY3841136 SC |
|
Experimental LY3841136 Dose 3 |
Participants will receive LY3841136 SC |
|
Experimental LY3841136 Dose 1 + Tirzepatide Dose 1 |
Participants will receive LY3841136 SC and Tirzepatide SC |
|
Experimental LY3841136 Dose 2 + Tirzepatide Dose 1 |
Participants will receive LY3841136 SC and Tirzepatide SC |
|
Experimental LY3841136 Dose 2 + Tirzepatide Dose 2 |
Participants will receive LY3841136 SC and Tirzepatide SC |
|
Experimental LY3841136 Dose 3 + Tirzepatide Dose 3 |
Participants will receive LY3841136 SC and Tirzepatide SC |
|
Active Comparator Tirzepatide Dose 3 |
Participants will receive Tirzepatide SC |
|
Experimental LY3841136 Dose 2 + Tirzepatide Dose 3 |
Participants will receive LY3841136 SC and Tirzepatide SC |
|
Placebo Comparator Placebo |
Participants will receive placebo administered SC. |
|
Recruiting Locations
Chandler, Arizona 85225
Phoenix, Arizona 85032
Scottsdale, Arizona 85260
Tucson, Arizona 85712
Greenbrae, California 94904
Huntington Park, California 90255
Rolling Hills Estates, California 90274
Walnut Creek, California 94598
Stamford, Connecticut 06905
Fleming Island, Florida 32003
Hialeah, Florida 33012
Miami, Florida 33165
New Port Richey, Florida 34652
Orlando, Florida 32803
The Villages, Florida 32162
Ammon, Idaho 83406
Chicago, Illinois 60640
Chicago, Illinois 60640
Skokie, Illinois 60077
West Des Moines, Iowa 50266
Topeka, Kansas 66606
Needham, Massachusetts 02492
New Bedford, Massachusetts 02740
Southfield, Michigan 48034
Troy, Michigan 48098
Saint Peters, Missouri 63303
Springfield, Missouri 65807
Las Vegas, Nevada 89128
Amherst, New York 14226
East Syracuse, New York 13057
Port Jefferson Station, New York 11776
Rochester, New York 14609
Greensboro, North Carolina 27405
Monroe, North Carolina 28112
Morehead City, North Carolina 28557
New Bern, North Carolina 28562
Cincinnati, Ohio 45212
Greenville, South Carolina 29607
Nashville, Tennessee 37211
Austin, Texas 78745
Dallas, Texas 75230
Dallas, Texas 75251
Houston, Texas 77079
San Antonio, Texas 78229
San Antonio, Texas 78240
Weslaco, Texas 78596
Danville, Virginia 24541
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) or1-317-615-4559
clinical_inquiry_hub@lilly.com