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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Obesity, Overweight

In brief

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.

Key facts

Study ID

NCT06643728

Run by

Eli Lilly and Company

People needed

252

Starts

2024-10-21

Expected to finish

2027-01-01

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Pinnacle Research Group, LLC — Anniston, Alabama, United States
• Central Research Associates — Birmingham, Alabama, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Clinical Neuroscience Solutions, Inc. dba CNS Healthcare — Jacksonville, Florida, United States
• Altus Research — Lake Worth, Florida, United States
• Suncoast Research Group — Miami, Florida, United States
• East-West Medical Research Institute — Honolulu, Hawaii, United States
• Great Lakes Clinical Trials - Ravenswood — Chicago, Illinois, United States
• SKY Integrative Medical Center/SKYCRNG — Ridgeland, Mississippi, United States
• Keystone Clinical Studies — Plymouth Meeting, Pennsylvania, United States
• Eastside Research Associates — Redmond, Washington, United States
• Rainier Clinical Research Center — Renton, Washington, United States

Full record on ClinicalTrials.gov

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