A Study of Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Participants With Obesity or Overweight With Type 2 Diabetes
NCT ID: NCT06901349
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2025-05-23
2025-06-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Bimagrumab Dose 1 + Tirzepatide Placebo
Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC
Bimagrumab
Administered SC
Tirzepatide Placebo
Administered SC
Bimagrumab Dose 2 + Tirzepatide Placebo
Participants will receive bimagrumab SC and tirzepatide placebo SC
Bimagrumab
Administered SC
Tirzepatide Placebo
Administered SC
Tirzepatide Dose 1 + Bimagrumab Placebo
Participants will receive tirzepatide SC and bimagrumab placebo SC
Tirzepatide
Administered SC
Bimagrumab Placebo
Administered SC
Tirzepatide Dose 2 + Bimagrumab Placebo
Participants will receive tirzepatide SC and bimagrumab placebo SC
Tirzepatide
Administered SC
Bimagrumab Placebo
Administered SC
Bimagrumab Dose 2 + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
Bimagrumab
Administered SC
Tirzepatide
Administered SC
Bimagrumab Dose 1 + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
Bimagrumab
Administered SC
Tirzepatide
Administered SC
Bimagrumab Dose 2 + Tirzepatide Dose 2
Participants will receive bimagrumab SC and tirzepatide SC
Bimagrumab
Administered SC
Tirzepatide
Administered SC
Bimagrumab Dose 1 + Tirzepatide Dose 2
Participants will receive bimagrumab SC and tirzepatide SC
Bimagrumab
Administered SC
Tirzepatide
Administered SC
Bimagrumab Placebo + Tirzepatide Placebo
Participants will receive bimagrumab placebo SC and tirzepatide placebo SC
Bimagrumab Placebo
Administered SC
Tirzepatide Placebo
Administered SC
Interventions
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Bimagrumab
Administered SC
Tirzepatide
Administered SC
Bimagrumab Placebo
Administered SC
Tirzepatide Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Yuma Clinical Trials
Yuma, Arizona, United States
Orange County Research Center
Lake Forest, California, United States
Healthy Brain Clinic
Long Beach, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Excel Medical Clinical Trials
Boca Raton, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, United States
L&C Professional Medical Research Institute
Miami, Florida, United States
Global Health Research Center, Inc.
Miami Lakes, Florida, United States
Charter Research - Winter Park
Orlando, Florida, United States
Charter Research - Lady Lake
The Villages, Florida, United States
Balanced Life Health Care Solutions/SKYCRNG
Lawrenceville, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Bingham Memorial Hospital
Blackfoot, Idaho, United States
Family First Medical Center
Idaho Falls, Idaho, United States
Deaconess Clinic- Gateway
Newburgh, Indiana, United States
Kur Research - Columbia Medical
Columbia, Maryland, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, United States
Remington-Davis, Inc
Columbus, Ohio, United States
Central States Research
Tulsa, Oklahoma, United States
Velocity Clinical Research, Dallas
Dallas, Texas, United States
PlanIt Research, PLLC
Houston, Texas, United States
Activian Clinical Research
Kingwood, Texas, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
CIPREC
Buenos Aires, Buenos Aires F.D., Argentina
Centro Médico Viamonte
Buenos Aires, Buenos Aires F.D., Argentina
Consultorio de Investigación Clínica EMO SRL
Buenos Aires, Buenos Aires F.D., Argentina
CIPREC
Buenos Aires, , Argentina
Richmond Clinical Trials
Richmond, British Columbia, Canada
Centricity Research Brampton Endocrinology
Brampton, Ontario, Canada
Premier Clinical Trial Network
Hamilton, Ontario, Canada
Your Research Network
Niagara Falls, Ontario, Canada
Centricity Research Pointe-Claire Multispecialty
Pointe-Claire, Quebec, Canada
Diex Recherche Trois-Rivieres
Trois-Rivières, Quebec, Canada
Diex Recherche Quebec
Québec, , Canada
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, Henan, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Jinan Central Hospital
Jinan, Shandong, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Tokuyama Clinic
Mihama-ku,Chiba City, Chiba, Japan
Hayashi Diabetes Internal Medicine Clinic
Chigasaki, Kanagawa, Japan
Shonan Takai Clinic
Kamakura, Kanagawa, Japan
Takai Internal Medicine Clinic
Kamakura-shi, Kanagawa, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, Japan
The Institute of Medical Science, Asahi Life Foundation
Chuo-ku, Tokyo, Japan
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, Japan
Countries
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Related Links
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A Study of Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Participants with Obesity or Overweight with Type 2 Diabetes
Other Identifiers
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J4Z-MC-GIDI
Identifier Type: OTHER
Identifier Source: secondary_id
27328
Identifier Type: -
Identifier Source: org_study_id
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