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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
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