Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Eli Lilly and Company
Conditions:
Obesity
Overweight
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 combinat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06603571
Start Date
September 20 2024
End Date
August 1 2026
Last Update
September 26 2025
Active Locations (52)
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1
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona, United States, 85225
2
HOPE Research Institute
Phoenix, Arizona, United States, 85032
3
Headlands Research - Scottsdale
Scottsdale, Arizona, United States, 85260
4
The Institute for Liver Health II dba Arizona Liver Health-Tucson
Tucson, Arizona, United States, 85712