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

September 19, 2025 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 317-615-4559
  • Email: clinical_inquiry_hub@lilly.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1061AAS
        • CIPREC
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1120AAC
        • Centro Medico Viamonte
      • Buenos Aires, Buenos Aires F.D., Argentina, C1405BUB
        • Consultorio de Investigacion Clinica EMO SRL
      • Buenos Aires, Buenos Aires F.D., Argentina, C1119ACN
        • CIPREC
  • Canada
      • Québec, Canada, G1V 4T3
        • Diex Recherche Québec
    • British Columbia
      • Richmond, British Columbia, Canada, V6V 2L1
        • Richmond Clinical Trials
    • Ontario
      • Brampton, Ontario, Canada, L6S 0C6
        • Centricity Research Brampton Endocrinology
      • Hamilton, Ontario, Canada, L8L 5G4
        • Premier Clinical Trial Network
      • Niagara Falls, Ontario, Canada, L2H 1H5
        • Your Research Network
    • Quebec
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Centricity Research Pointe-Claire Multispecialty
      • Trois-Rivières, Quebec, Canada, G9A 4P3
        • Diex Recherche Trois-rivieres
  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • The Fourth Affiliated Hospital of Harbin Medical University
    • Henan
      • Luoyang Shi, Henan, China, 471003
        • The First Affiliated Hospital of Henan University of Science &Technology
    • Jiangsu
      • Nanjing, Jiangsu, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Shanghai Sixth People's Hospital
  • Japan
    • Chiba
      • Mihama-ku,Chiba City, Chiba, Japan, 261-0004
        • Tokuyama Clinic
    • Kanagawa
      • Chigasaki, Kanagawa, Japan, 253-0044
        • Hayashi Diabetes Internal Medicine Clinic
      • Kamakura, Kanagawa, Japan, 247-0055
        • Shonan Takai Clinic
      • Kamakura-shi, Kanagawa, Japan, 247-0056
        • Takai Internal Medicine Clinic
    • Osaka
      • Suita-shi, Osaka, Japan, 565-0853
        • Medical Corporation Heishinkai OCROM Clinic
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 103-0027
        • Tokyo-Eki Center-building Clinic
      • Chuo-ku, Tokyo, Japan, 104-0031
        • Fukuwa Clinic
      • Chuo-ku, Tokyo, Japan, 103-0002
        • The Institute of Medical Science, Asahi Life Foundation
  • United States
    • Arizona
      • Yuma, Arizona, United States, 85364
        • Yuma Clinical Trials
    • California
      • Lake Forest, California, United States, 92630
        • Orange County Research Center
      • Long Beach, California, United States, 90804
        • Healthy Brain Clinic
      • Northridge, California, United States, 91325
        • Valley Clinical Trials, Inc.
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Excel Medical Clinical Trials
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
      • Miami, Florida, United States, 33144
        • L&C Professional Medical Research Institute
      • Miami Lakes, Florida, United States, 33016
        • Global Health Research Center, Inc.
      • Orlando, Florida, United States, 32803
        • Charter Research - Winter Park
      • The Villages, Florida, United States, 32162
        • Charter Research - Lady Lake
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Balanced Life Health Care Solutions/SKYCRNG
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East-West Medical Research Institute
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Bingham Memorial Hospital
      • Idaho Falls, Idaho, United States, 83404
        • Family First Medical Center
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • Deaconess Clinic- Gateway
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Kur Research - Columbia Medical
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Great Lakes Research Group, Inc.
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Remington-Davis, Inc
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Central States Research
    • Texas
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Research, Dallas
      • Houston, Texas, United States, 77079
        • PlanIt Research, PLLC
      • Kingwood, Texas, United States, 77339
        • Activian Clinical Research
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bimagrumab Dose 1 + Tirzepatide Placebo
Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC
Drug: Bimagrumab
Administered SC
Other Names:
  • LY3985863
Drug: Tirzepatide Placebo
Administered SC
Experimental: Bimagrumab Dose 2 + Tirzepatide Placebo
Participants will receive bimagrumab SC and tirzepatide placebo SC
Drug: Bimagrumab
Administered SC
Other Names:
  • LY3985863
Drug: Tirzepatide Placebo
Administered SC
Experimental: Tirzepatide Dose 1 + Bimagrumab Placebo
Participants will receive tirzepatide SC and bimagrumab placebo SC
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Drug: Bimagrumab Placebo
Administered SC
Experimental: Tirzepatide Dose 2 + Bimagrumab Placebo
Participants will receive tirzepatide SC and bimagrumab placebo SC
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Drug: Bimagrumab Placebo
Administered SC
Experimental: Bimagrumab Dose 2 + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Drug: Bimagrumab
Administered SC
Other Names:
  • LY3985863
Experimental: Bimagrumab Dose 1 + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Drug: Bimagrumab
Administered SC
Other Names:
  • LY3985863
Experimental: Bimagrumab Dose 2 + Tirzepatide Dose 2
Participants will receive bimagrumab SC and tirzepatide SC
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Drug: Bimagrumab
Administered SC
Other Names:
  • LY3985863
Experimental: Bimagrumab Dose 1 + Tirzepatide Dose 2
Participants will receive bimagrumab SC and tirzepatide SC
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Drug: Bimagrumab
Administered SC
Other Names:
  • LY3985863
Placebo Comparator: Bimagrumab Placebo + Tirzepatide Placebo
Participants will receive bimagrumab placebo SC and tirzepatide placebo SC
Drug: Tirzepatide Placebo
Administered SC
Drug: Bimagrumab Placebo
Administered SC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 36
Baseline, Week 36

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline in Body Mass Index (BMI)
Time Frame: Baseline, Week 36
Baseline, Week 36
Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA)
Time Frame: Baseline, Week 36
Baseline, Week 36
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 36
Baseline, Week 36
Percentage of Participants Achieving ≥5% Body Weight Reduction
Time Frame: Baseline, Week 36
Baseline, Week 36
Percentage of Participants Achieving ≥10% Body Weight Reduction
Time Frame: Baseline, Week 36
Baseline, Week 36
Percentage of Participants Achieving ≥15% Body Weight Reduction
Time Frame: Baseline, Week 36
Baseline, Week 36
Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 36
Baseline, Week 36
Change from Baseline in Waist-to-Height Ratio (WHtR)
Time Frame: Baseline, Week 36
Baseline, Week 36
Percent Change from Baseline in Visceral Adipose Tissue (VAT) by Magnetic Resonance Imaging (MRI)
Time Frame: Baseline, Week 36
Baseline, Week 36
Change from Baseline in Liver Fat by MRI
Time Frame: Baseline, Week 36
Baseline, Week 36
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Time Frame: Baseline, Week 36
Baseline, Week 36
Percent Change from Baseline in Total Cholesterol
Time Frame: Baseline, Week 36
Baseline, Week 36
Percent Change from Baseline in Triglycerides (TG)
Time Frame: Baseline, Week 36
Baseline, Week 36
Change from Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline, Week 36
Baseline, Week 36
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Bimagrumab
Time Frame: Predose through Week 52
Predose through Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27328
  • J4Z-MC-GIDI (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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