Study Stopped
Study terminated for strategic business reasons
A Study of Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Participants With Obesity or Overweight With Type 2 Diabetes
A Phase 2b Double-Blind, Randomized, Placebo-Controlled Study of Bimagrumab and Tirzepatide, Alone or in Combination, to Investigate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes
2 other identifiers
interventional
N/A
5 countries
50
Brief Summary
The main purpose of this study is to see how well and how safely bimagrumab, tirzepatide, and the combination, work in lowering body weight in participants with obesity or overweight and type 2 diabetes. Participation in the study will last about 13 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2025
Shorter than P25 for phase_2 obesity
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2025
CompletedFirst Posted
Study publicly available on registry
March 28, 2025
CompletedStudy Start
First participant enrolled
May 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2025
CompletedSeptember 24, 2025
September 1, 2025
18 days
March 24, 2025
September 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change from Baseline in Body Weight
Baseline, Week 36
Secondary Outcomes (15)
Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA)
Baseline, Week 36
Change from Baseline in Hemoglobin A1c (HbA1c)
Baseline, Week 36
Percentage of Participants Achieving ≥5% Body Weight Reduction
Baseline, Week 36
Percentage of Participants Achieving ≥10% Body Weight Reduction
Baseline, Week 36
Percentage of Participants Achieving ≥15% Body Weight Reduction
Baseline, Week 36
- +10 more secondary outcomes
Study Arms (9)
Bimagrumab Dose 1 + Tirzepatide Placebo
EXPERIMENTALParticipants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC
Bimagrumab Dose 2 + Tirzepatide Placebo
EXPERIMENTALParticipants will receive bimagrumab SC and tirzepatide placebo SC
Tirzepatide Dose 1 + Bimagrumab Placebo
EXPERIMENTALParticipants will receive tirzepatide SC and bimagrumab placebo SC
Tirzepatide Dose 2 + Bimagrumab Placebo
EXPERIMENTALParticipants will receive tirzepatide SC and bimagrumab placebo SC
Bimagrumab Dose 2 + Tirzepatide Dose 1
EXPERIMENTALParticipants will receive bimagrumab SC and tirzepatide SC
Bimagrumab Dose 1 + Tirzepatide Dose 1
EXPERIMENTALParticipants will receive bimagrumab SC and tirzepatide SC
Bimagrumab Dose 2 + Tirzepatide Dose 2
EXPERIMENTALParticipants will receive bimagrumab SC and tirzepatide SC
Bimagrumab Dose 1 + Tirzepatide Dose 2
EXPERIMENTALParticipants will receive bimagrumab SC and tirzepatide SC
Bimagrumab Placebo + Tirzepatide Placebo
PLACEBO COMPARATORParticipants will receive bimagrumab placebo SC and tirzepatide placebo SC
Interventions
Administered SC
Administered SC
Administered SC
Administered SC
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Yuma Clinical Trials
Yuma, Arizona, 85364, United States
Orange County Research Center
Lake Forest, California, 92630, United States
Healthy Brain Clinic
Long Beach, California, 90804, United States
Valley Clinical Trials, Inc.
Northridge, California, 91325, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, 32256, United States
L&C Professional Medical Research Institute
Miami, Florida, 33144, United States
Global Health Research Center, Inc.
Miami Lakes, Florida, 33016, United States
Charter Research - Winter Park
Orlando, Florida, 32803, United States
Charter Research - Lady Lake
The Villages, Florida, 32162, United States
Balanced Life Health Care Solutions/SKYCRNG
Lawrenceville, Georgia, 30046, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Bingham Memorial Hospital
Blackfoot, Idaho, 83221, United States
Family First Medical Center
Idaho Falls, Idaho, 83404, United States
Deaconess Clinic- Gateway
Newburgh, Indiana, 47630, United States
Kur Research - Columbia Medical
Columbia, Maryland, 21045, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514, United States
Remington-Davis, Inc
Columbus, Ohio, 43215, United States
Central States Research
Tulsa, Oklahoma, 74136, United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230, United States
PlanIt Research, PLLC
Houston, Texas, 77079, United States
Activian Clinical Research
Kingwood, Texas, 77339, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
CIPREC
Buenos Aires, Buenos Aires F.D., C1119ACN, Argentina
Centro Médico Viamonte
Buenos Aires, Buenos Aires F.D., C1120AAC, Argentina
Consultorio de Investigación Clínica EMO SRL
Buenos Aires, Buenos Aires F.D., C1405BUB, Argentina
CIPREC
Buenos Aires, C1061AAS, Argentina
Richmond Clinical Trials
Richmond, British Columbia, V6V 2L1, Canada
Centricity Research Brampton Endocrinology
Brampton, Ontario, L6S 0C6, Canada
Premier Clinical Trial Network
Hamilton, Ontario, L8L 5G4, Canada
Your Research Network
Niagara Falls, Ontario, L2H 1H5, Canada
Centricity Research Pointe-Claire Multispecialty
Pointe-Claire, Quebec, H9R 4S3, Canada
Diex Recherche Trois-Rivieres
Trois-Rivières, Quebec, G9A 4P3, Canada
Diex Recherche Quebec
Québec, G1V 4T3, Canada
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, Henan, 471003, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Tokuyama Clinic
Mihama-ku,Chiba City, Chiba, 261-0004, Japan
Hayashi Diabetes Internal Medicine Clinic
Chigasaki, Kanagawa, 253-0044, Japan
Shonan Takai Clinic
Kamakura, Kanagawa, 247-0055, Japan
Takai Internal Medicine Clinic
Kamakura-shi, Kanagawa, 247-0056, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, 565-0853, Japan
The Institute of Medical Science, Asahi Life Foundation
Chuo-ku, Tokyo, 103-0002, Japan
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, 103-0027, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2025
First Posted
March 28, 2025
Study Start
May 23, 2025
Primary Completion
June 10, 2025
Study Completion
June 10, 2025
Last Updated
September 24, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.