A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Overweight; Obesity

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06643728

27265

J4Z-MC-GIDF (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy and safety of Bimagrumab and Tirzepatide, alone or in combination, in adults with obesity or overweight, with at least one obesity related comorbidity, without Type 2 Diabetes. The study will last about 54 weeks.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a BMI of

  • ≥30 kilograms per square meter (kg/m2) or

  • ≥27 kg/m2 and <30 kg/m2, with at least one of the following weight-related comorbidities:

    • Hypertension
    • Dyslipidemia
    • Cardiovascular disease
    • Obstructive sleep apnea

• 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 at least one laboratory value suggestive of diabetes during screening

• Use of metformin, or any other glucose-lowering medications

• Have Type 1 Diabetes, latent autoimmune diabetes, been diagnosed with any form of diabetes mellitus except for a prior diagnosis of gestational diabetes mellitus, or history of ketoacidosis or hyperosmolar 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 ongoing or a history of frequent intermittent or chronic tachyarrhythmia syndromes

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

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

• 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

• Have renal impairment, measured as estimated glomerular filtration rate <30 mL/minute/1.73 m2

• 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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140 participants in 7 patient groups, including a placebo group

Tirzepatide Dose 1

Active Comparator group

Description:

Participants will receive Tirzepatide subcutaneously (SC)

Treatment:

Drug: Tirzepatide

Tirzepatide Dose 2

Active Comparator group

Description:

Participants will receive Tirzepatide SC

Treatment:

Drug: Tirzepatide

Bimagrumab Dose 1 + Tirzepatide Dose 1

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 Dose 2

Experimental group

Description:

Participants will receive Bimagrumab SC

Treatment:

Drug: Bimagrumab

Bimagrumab Dose 2 + Tirzepatide Dose 2

Experimental group

Description:

Participants will receive Bimagrumab SC and Tirzepatide SC

Treatment:

Drug: Tirzepatide

Drug: Bimagrumab

Placebo

Placebo Comparator group

Description:

Participants will receive Placebo SC

Treatment:

Drug: Placebo