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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

NCT06603571

Active Not RecruitingPhase 2

Sponsor: Eli Lilly and Company

Conditions: Obesity, Overweight

Interventions: LY3841136, Tirzepatide, Placebo

Countries: United States, Argentina

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (52)

Chandler, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Greenbrae, California, United States
Huntington Park, California, United States
Rolling Hills Estates, California, United States
Walnut Creek, California, United States
Stamford, Connecticut, United States
Fleming Island, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Orlando, Florida, United States
The Villages, Florida, United States
Ammon, Idaho, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Skokie, Illinois, United States
West Des Moines, Iowa, United States
Topeka, Kansas, United States
Needham, Massachusetts, United States
New Bedford, Massachusetts, United States
Southfield, Michigan, United States
Troy, Michigan, United States
City of Saint Peters, Missouri, United States
Springfield, Missouri, United States
Las Vegas, Nevada, United States
Amherst, New York, United States
East Syracuse, New York, United States
+ 22 more on CT.gov