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Search / Trial NCT06901349

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

Launched by ELI LILLY AND COMPANY · Mar 24, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Type 2 Diabetes Muscle Lean Fat

ClinConnect Summary

This clinical trial is looking at two medications, bimagrumab and tirzepatide, to see how well they help people with obesity or being overweight and type 2 diabetes lose weight. The study will also explore whether using these medications together is more effective. If you participate, the study will last about 13 months, and you'll be closely monitored for safety and effectiveness.

To take part in this study, you need to be between 18 and 75 years old, have type 2 diabetes, and have a body mass index (BMI) of 27 or higher, which means you are considered overweight. You should also have maintained a stable weight for the last three months. However, this trial is not for everyone; for instance, if you have certain heart conditions, have had surgery for obesity, or have other specific health issues, you may not be eligible. If you qualify and choose to participate, you'll receive detailed information about what to expect during the study and how it may help you.

Gender

ALL

Eligibility criteria

  • 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

About Eli Lilly And Company

Eli Lilly and Company is a global healthcare leader dedicated to creating innovative medicines that improve patient outcomes across a range of therapeutic areas, including diabetes, oncology, immunology, and neurodegenerative diseases. With a rich history of scientific research and a commitment to advancing healthcare, Lilly invests significantly in clinical trials to develop new treatments and enhance existing therapies. The company prioritizes patient safety and ethical standards in its clinical research, fostering collaboration with healthcare professionals and stakeholders to ensure the delivery of high-quality, evidence-based solutions that address unmet medical needs worldwide.

Locations

Walnut Creek, California, United States

Buenos Aires, , Argentina

Bay City, Michigan, United States

Honolulu, Hawaii, United States

Harbin, Heilongjiang, China

Bellevue, Washington, United States

Blackfoot, Idaho, United States

Suzhou, Jiangsu, China

Shanghai, Shanghai, China

Northridge, California, United States

Chapel Hill, North Carolina, United States

Nanjing, Jiangsu, China

Tulsa, Oklahoma, United States

Chuo Ku, Tokyo, Japan

Columbus, Ohio, United States

Jinan, Shandong, China

Miami, Florida, United States

Boca Raton, Florida, United States

Yuma, Arizona, United States

Chuo Ku, Tokyo, Japan

Newburgh, Indiana, United States

Suita Shi, Osaka, Japan

Idaho Falls, Idaho, United States

Chuo Ku, Tokyo, Japan

Miami Lakes, Florida, United States

Luoyang Shi, Henan, China

Chigasaki, Kanagawa, Japan

Kamakura Shi, Kanagawa, Japan

Kamakura, Kanagawa, Japan

Jacksonville, Florida, United States

Mihama Ku,Chiba City, Chiba, Japan

Lawrenceville, Georgia, United States

Long Beach, California, United States

Dallas, Texas, United States

Trois Rivieres, Quebec, Canada

Shanghai, Shanghai, China

Brampton, Ontario, Canada

The Villages, Florida, United States

Quebec, , Canada

Niagara Falls, Ontario, Canada

Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Kingwood, Texas, United States

Houston, Texas, United States

Lake Forest, California, United States

Columbia, Maryland, United States

Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Orlando, Florida, United States

Richmond, British Columbia, Canada

Hamilton, Ontario, Canada

Ciudad Autonoma De Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina

Pointe Claire, Quebec, Canada

Buenos Aires, , Argentina

Ciudad Autonoma De Buenos Aires, , Argentina

Patients applied

0 patients applied

Trial Officials

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Study Director

Eli Lilly and Company

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported