Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT06603571 for Obesity, Overweight is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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 Phase 2 350 Master Protocol
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
- 18809
- W8M-MC-LAA2 (Other Identifier) (Eli Lilly and Company)
- W8M-MC-CWMM Master Protocol (Other Identifier) (Eli Lilly and Company)
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalLY3841136 Dose 1 Participants will receive LY3841136 subcutaneously (SC) | LY3841136 Administered SC |
ExperimentalLY3841136 Dose 2 Participants will receive LY3841136 SC | LY3841136 Administered SC |
ExperimentalLY3841136 Dose 3 Participants will receive LY3841136 SC | LY3841136 Administered SC |
ExperimentalLY3841136 Dose 1 + Tirzepatide Dose 1 Participants will receive LY3841136 SC and Tirzepatide SC | LY3841136 Administered SC Tirzepatide Administered SC |
ExperimentalLY3841136 Dose 2 + Tirzepatide Dose 1 Participants will receive LY3841136 SC and Tirzepatide SC | LY3841136 Administered SC Tirzepatide Administered SC |
ExperimentalLY3841136 Dose 2 + Tirzepatide Dose 2 Participants will receive LY3841136 SC and Tirzepatide SC | LY3841136 Administered SC Tirzepatide Administered SC |
ExperimentalLY3841136 Dose 3 + Tirzepatide Dose 3 Participants will receive LY3841136 SC and Tirzepatide SC | LY3841136 Administered SC Tirzepatide Administered SC |
Active ComparatorTirzepatide Dose 3 Participants will receive Tirzepatide SC | Tirzepatide Administered SC |
ExperimentalLY3841136 Dose 2 + Tirzepatide Dose 3 Participants will receive LY3841136 SC and Tirzepatide SC | LY3841136 Administered SC Tirzepatide Administered SC |
Placebo ComparatorPlacebo Participants will receive placebo administered SC. | Placebo Administered SC |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Percent Change from Baseline in Body Weight | Baseline, Week 48 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | |
PK: Maximum Concentration (Cmax) of LY3841136 | Baseline, Week 48 |
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)
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.
Arizona
California
Connecticut
Florida
Idaho
Illinois
Iowa
Kansas
Massachusetts
Michigan
Missouri
Nevada
New York
North Carolina
Ohio
South Carolina
Tennessee
Texas
Virginia
Washington