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

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: Placebo; Drug: LY3841136; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06603571

W8M-MC-LAA2 (Other Identifier)

W8M-MC-CWMM Master Protocol (Other Identifier)

18809

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 10 patient groups, including a placebo group

LY3841136 Dose 1

Experimental group

Description:

Participants will receive LY3841136 subcutaneously (SC)

Treatment:

Drug: LY3841136

LY3841136 Dose 2

Experimental group

Description:

Participants will receive LY3841136 SC

Treatment:

Drug: LY3841136

LY3841136 Dose 3

Experimental group

Description:

Participants will receive LY3841136 SC

Treatment:

Drug: LY3841136

LY3841136 Dose 1 + Tirzepatide Dose 1

Experimental group

Description:

Participants will receive LY3841136 SC and Tirzepatide SC

Treatment:

Drug: Tirzepatide

Drug: LY3841136

LY3841136 Dose 2 + Tirzepatide Dose 1

Experimental group

Description:

Participants will receive LY3841136 SC and Tirzepatide SC

Treatment:

Drug: Tirzepatide

Drug: LY3841136

LY3841136 Dose 2 + Tirzepatide Dose 2

Experimental group

Description:

Participants will receive LY3841136 SC and Tirzepatide SC

Treatment:

Drug: Tirzepatide

Drug: LY3841136

LY3841136 Dose 3 + Tirzepatide Dose 3

Experimental group

Description:

Participants will receive LY3841136 SC and Tirzepatide SC

Treatment:

Drug: Tirzepatide

Drug: LY3841136

Tirzepatide Dose 3

Active Comparator group

Description:

Participants will receive Tirzepatide SC

Treatment:

Drug: Tirzepatide

LY3841136 Dose 2 + Tirzepatide Dose 3

Experimental group

Description:

Participants will receive LY3841136 SC and Tirzepatide SC

Treatment:

Drug: Tirzepatide

Drug: LY3841136

Placebo

Placebo Comparator group

Description:

Participants will receive placebo administered SC.

Treatment:

Drug: Placebo