A Study of Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Participants With Obesity or Overweight With Type 2 Diabetes

Lilly

Status and phase: Begins enrollment in 1 month; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: Bimagrumab Placebo; Drug: Tirzepatide Placebo; Drug: Bimagrumab; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06901349

J4Z-MC-GIDI (Other Identifier)

27328

Details and patient eligibility

About

The main purpose of this study is to see how well and how safely bimagrumab, tirzepatide, and the combination, work in lowering body weight in participants with obesity or overweight and type 2 diabetes. Participation in the study will last about 13 months.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have type 2 diabetes
• Have a BMI of ≥27 kilograms per square meter (kg/m2)
• Have had a stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss)

Exclusion criteria

• Have a prior or planned surgical treatment for obesity,

• Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar state or coma

• Have poorly controlled hypertension

• Have any of the following cardiovascular conditions within 3 months prior to screening:

  • acute myocardial infarction
  • cerebrovascular accident (stroke)
  • unstable angina, or
  • hospitalization due to congestive heart failure

• Have a history of New York Heart Association (NYHA) Functional Classification III or IV congestive heart failure

• Have ongoing or a history of frequent intermittent or chronic tachyarrhythmia syndromes

• Have ongoing or a history of bradyarrhythmias other than sinus bradycardia

• Have renal impairment

• Have a history of symptomatic gallbladder disease within the past 2 years

• Have signs and symptoms of any liver disease

• Have a disease or condition known to cause gastrointestinal malabsorption or a known clinically significant gastric emptying abnormality

• Have a history of acute or chronic pancreatitis

• Currently taking or have taken medications that may cause significant weight gain or promote weight loss within 3 months prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 9 patient groups, including a placebo group

Bimagrumab Dose 1 + Tirzepatide Placebo

Experimental group

Description:

Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC

Treatment:

Drug: Bimagrumab

Drug: Tirzepatide Placebo

Bimagrumab Dose 2 + Tirzepatide Placebo

Experimental group

Description:

Participants will receive bimagrumab SC and tirzepatide placebo SC

Treatment:

Drug: Bimagrumab

Drug: Tirzepatide Placebo

Tirzepatide Dose 1 + Bimagrumab Placebo

Experimental group

Description:

Participants will receive tirzepatide SC and bimagrumab placebo SC

Treatment:

Drug: Tirzepatide

Drug: Bimagrumab Placebo

Tirzepatide Dose 2 + Bimagrumab Placebo

Experimental group

Description:

Participants will receive tirzepatide SC and bimagrumab placebo SC

Treatment:

Drug: Tirzepatide

Drug: Bimagrumab Placebo

Bimagrumab Dose 2 + Tirzepatide Dose 1

Experimental group

Description:

Participants will receive bimagrumab SC and tirzepatide SC

Treatment:

Drug: Tirzepatide

Drug: Bimagrumab

Bimagrumab Dose 1 + Tirzepatide Dose 1

Experimental group

Description:

Participants will receive bimagrumab SC and tirzepatide SC

Treatment:

Drug: Tirzepatide

Drug: Bimagrumab

Bimagrumab Dose 2 + Tirzepatide Dose 2

Experimental group

Description:

Participants will receive bimagrumab SC and tirzepatide SC

Treatment:

Drug: Tirzepatide

Drug: Bimagrumab

Bimagrumab Dose 1 + Tirzepatide Dose 2

Experimental group

Description:

Participants will receive bimagrumab SC and tirzepatide SC

Treatment:

Drug: Tirzepatide

Drug: Bimagrumab

Bimagrumab Placebo + Tirzepatide Placebo

Placebo Comparator group

Description:

Participants will receive bimagrumab placebo SC and tirzepatide placebo SC

Treatment:

Drug: Tirzepatide Placebo

Drug: Bimagrumab Placebo