A Study of Bimagrumab Alone (LY3985863) and Bimagrumab With Tirzepatide (LY900042) in Healthy Participants

October 8, 2025 updated by: Eli Lilly and Company

A Phase 1, Relative Bioavailability Study of Bimagrumab (LY3985863) Test and Reference Materials, and Bimagrumab Test Material Coadministration and Coformulation With Tirzepatide (LY900042), in Healthy Participants

The main purpose of this study is to evaluate the body concentration of different forms of bimagrumab, administered alone or with tirzepatide. Participation in the study will last about 4.5 months, including screening and follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75247
        • Fortrea Clinical Research Unit

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Are considered healthy as determined by medical evaluation including medical history and physical examination
  • Have a body mass index (BMI) within the range of 22.0 to 30.0 kilograms per square meter (kg/m2), inclusive

Exclusion Criteria:

  • Have current or a history of pancreatitis or hepatitis
  • Have a self-reported increase or decrease in body weight, greater than 5 kilograms (kg), within 3 months prior to screening
  • Have uncontrolled high blood pressure
  • Have taken medications or alternative remedies to 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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bimagrumab Dose 1 Reference Material
Participants will receive a single dose of bimagrumab subcutaneously (SC)
Drug: Bimagrumab
Administered SC
Other Names:
  • BYM338
  • LY3985863
  • VER201
Experimental: Bimagrumab Dose 1 Test Material + Tirzepatide (Coadministration)
Participants will receive a single dose of bimagrumab SC and a single dose of tirzepatide SC
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Drug: Bimagrumab
Administered SC
Other Names:
  • BYM338
  • LY3985863
  • VER201
Experimental: Bimagrumab Dose 1 Test Material + Tirzepatide (Coformulation)
Participants will receive a single dose of bimagrumab with tirzepatide SC
Drug: Bimagrumab + Tirzepatide Coformulation
Administered SC
Other Names:
  • LY900042
Experimental: Bimagrumab Dose 2 Test Material + Tirzepatide (Coadministration)
Participants will receive bimagrumab SC and tirzepatide SC for 4 weeks
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Drug: Bimagrumab
Administered SC
Other Names:
  • BYM338
  • LY3985863
  • VER201
Experimental: Bimagrumab Dose 2 Test Material + Tirzepatide (Coformulation)
Participants will receive bimagrumab with tirzepatide SC for 4 weeks
Drug: Bimagrumab + Tirzepatide Coformulation
Administered SC
Other Names:
  • LY900042

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Bimagrumab Test Material
Time Frame: Predose through Week 13
Predose through Week 13
PK: Cmax of Bimagrumab Reference Material
Time Frame: Predose through Week 13
Predose through Week 13
PK: Cmax of Bimagrumab Coadministered with Tirzepatide
Time Frame: Predose through Week 13
Predose through Week 13
PK: Cmax of Tirzepatide Coadministered with Bimagrumab
Time Frame: Predose through Week 16
Predose through Week 16
PK: Cmax of Bimagrumab Coformulated with Tirzepatide
Time Frame: Predose through Week 16
Predose through Week 16
PK: Cmax of Tirzepatide Coformulated with Bimagrumab
Time Frame: Predose through Week 16
Predose through Week 16
PK: Area Under the Curve from Zero to Infinity AUC (AUC(0-∞)) of Bimagrumab Test Material
Time Frame: Predose through Week 13
Predose through Week 13
PK: AUC(0-∞) of Bimagrumab Reference Material
Time Frame: Predose through Week 13
Predose through Week 13
PK: AUC(0-∞) of Bimagrumab Coadministered with Tirzepatide
Time Frame: Predose through Week 13
Predose through Week 13
PK: AUC(0-∞) of Tirzepatide Coadministered with Bimagrumab
Time Frame: Predose through Week 16
Predose through Week 16
PK: AUC(0-∞) of Bimagrumab Coformulated with Tirzepatide
Time Frame: Predose through Week 16
Predose through Week 16
PK: AUC(0-∞) of Tirzepatide Coformulated with Bimagrumab
Time Frame: Predose through Week 16
Predose through Week 16

Collaborators and Investigators

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

Sponsor

Eli Lilly and Company

Investigators

  • 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 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)

March 25, 2025

Primary Completion (Actual)

September 26, 2025

Study Completion (Actual)

September 26, 2025

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 24, 2025

Study Record Updates

Last Update Posted (Estimated)

October 9, 2025

Last Update Submitted That Met QC Criteria

October 8, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27286
  • J4Z-MC-GIDG (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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