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

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: Healthy
• Intervention / Treatment: Drug: Tirzepatide; Drug: Bimagrumab; Drug: Bimagrumab + Tirzepatide Coformulation

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

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

Collaborators and Investigators

• 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

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: Amino Acids, Peptides, and Proteins; Proteins; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Tirzepatide; bimagrumab
• 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