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

Last updated: March 21, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

2

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

Tirzepatide Placebo

Tirzepatide

Bimagrumab Placebo

Clinical Study ID

NCT06643728
27265
J4Z-MC-GIDF
  • Ages 18-75
  • All Genders

Study Summary

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 70 weeks.

Eligibility Criteria

Inclusion

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-relatedcomorbidities:

  • Hypertension

  • Dyslipidemia

  • Cardiovascular disease

  • Obstructive sleep apnea

  • Have had a stable body weight for the 3 months prior to randomization (<5% bodyweight gain and/or loss)

Exclusion

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 ofdiabetes mellitus except for a prior diagnosis of gestational diabetes mellitus, orhistory of ketoacidosis or hyperosmolar coma

  • Have poorly controlled hypertension

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

  • 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 tachyarrhythmiasyndromes

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

  • Have a history of New York Heart Association (NYHA) Functional Classification III orIV 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 knownclinically significant gastric emptying abnormality

  • Have a history of acute or chronic pancreatitis

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

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

Study Design

Total Participants: 240
Treatment Group(s): 5
Primary Treatment: Tirzepatide Placebo
Phase: 2
Study Start date:
October 21, 2024
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Pinnacle Research Group, LLC

    Anniston, Alabama 36207
    United States

    Active - Recruiting

  • Central Research Associates

    Birmingham, Alabama 35205
    United States

    Active - Recruiting

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Altus Research

    Lake Worth, Florida 33461
    United States

    Active - Recruiting

  • Altus Research Loc. 1

    Lake Worth, Florida 33461
    United States

    Site Not Available

  • Suncoast Research Group

    Miami, Florida 33135
    United States

    Active - Recruiting

  • East-West Medical Research Institute

    Honolulu, Hawaii 96814
    United States

    Active - Recruiting

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois 60640
    United States

    Active - Recruiting

  • Great Lakes Clinical Trials - Gurnee

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi 39157
    United States

    Site Not Available

  • Keystone Clinical Studies

    Plymouth Meeting, Pennsylvania 19462
    United States

    Active - Recruiting

  • Eastside Research Associates

    Redmond, Washington 98052
    United States

    Active - Recruiting

  • Rainier Clinical Research Center

    Renton, Washington 98057
    United States

    Active - Recruiting

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