A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight
NCT ID: NCT06643728
Last Updated: 2025-09-26
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2024-10-21
2027-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Participants With Obesity or Overweight With Type 2 Diabetes
NCT06901349
A Study of Bimagrumab Alone (LY3985863) and Bimagrumab With Tirzepatide (LY900042) in Healthy Participants
NCT06890611
Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese
NCT05616013
A Study to Investigate Weight Management With LY3841136 and Tirzepatide (LY3298176), Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes
NCT06603571
A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity
NCT06373146
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part A: Bimagrumab Dose 2 + Tirzepatide Placebo
Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC
Bimagrumab
Administered SC
Tirzepatide Placebo
Administered SC
Part A: Bimagrumab Placebo + Tirzepatide Dose 1
Participants will receive bimagrumab placebo SC and tirzepatide SC
Tirzepatide
Administered SC
Bimagrumab Placebo
Administered SC
Part A: Bimagrumab Placebo + Tirzepatide Dose 2
Participants will receive bimagrumab placebo SC and tirzepatide SC
Tirzepatide
Administered SC
Bimagrumab Placebo
Administered SC
Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
Bimagrumab
Administered SC
Tirzepatide
Administered SC
Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2
Participants will receive bimagrumab SC and tirzepatide SC
Bimagrumab
Administered SC
Tirzepatide
Administered SC
Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2
Participants will receive bimagrumab SC and tirzepatide SC
Bimagrumab
Administered SC
Tirzepatide
Administered SC
Part A: Bimagrumab Placebo + Tirzepatide Placebo
Participants will receive bimagrumab placebo SC and tirzepatide placebo SC
Bimagrumab Placebo
Administered SC
Tirzepatide Placebo
Administered SC
Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
Bimagrumab
Administered SC
Tirzepatide
Administered SC
Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
Bimagrumab
Administered SC
Tirzepatide
Administered SC
Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
Bimagrumab
Administered SC
Tirzepatide
Administered SC
Part B: Bimagrumab Dose 1 + Tirzepatide Placebo
Participants will receive bimagrumab SC and tirzepatide placebo SC
Bimagrumab
Administered SC
Tirzepatide Placebo
Administered SC
Part B: Bimagrumab Placebo + Tirzepatide Placebo
Participants will receive bimagrumab placebo SC and tirzepatide placebo SC
Bimagrumab Placebo
Administered SC
Tirzepatide Placebo
Administered SC
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bimagrumab
Administered SC
Tirzepatide
Administered SC
Bimagrumab Placebo
Administered SC
Tirzepatide Placebo
Administered SC
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ≥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)
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
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
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
J4Z-MC-GIDF
Identifier Type: OTHER
Identifier Source: secondary_id
27265
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.