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 Sex
- 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
More Details
- NCT ID
- NCT06603571
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company