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

NCT06890611 | Completed Phase 1 FDA Drug

• 2 other identifiers: 27286J4Z-MC-GIDG
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (5)

Bimagrumab Dose 1 Reference Material

EXPERIMENTAL

Participants will receive a single dose of bimagrumab subcutaneously (SC)

Drug: Bimagrumab

Bimagrumab Dose 1 Test Material + Tirzepatide (Coadministration)

EXPERIMENTAL

Participants will receive a single dose of bimagrumab SC and a single dose of tirzepatide SC

Drug: Bimagrumab; Drug: Tirzepatide

Bimagrumab Dose 1 Test Material + Tirzepatide (Coformulation)

EXPERIMENTAL

Participants will receive a single dose of bimagrumab with tirzepatide SC

Drug: Bimagrumab + Tirzepatide Coformulation

Bimagrumab Dose 2 Test Material + Tirzepatide (Coadministration)

EXPERIMENTAL

Participants will receive bimagrumab SC and tirzepatide SC for 4 weeks

Drug: Bimagrumab; Drug: Tirzepatide

Bimagrumab Dose 2 Test Material + Tirzepatide (Coformulation)

EXPERIMENTAL

Participants will receive bimagrumab with tirzepatide SC for 4 weeks

Drug: Bimagrumab + Tirzepatide Coformulation

Interventions

Bimagrumab DRUG

Administered SC

Also known as: LY3985863, BYM338, VER201

Bimagrumab Dose 1 Reference Material; Bimagrumab Dose 1 Test Material + Tirzepatide (Coadministration); Bimagrumab Dose 2 Test Material + Tirzepatide (Coadministration)

Tirzepatide DRUG

Administered SC

Also known as: LY3298176

Bimagrumab Dose 1 Test Material + Tirzepatide (Coadministration); Bimagrumab Dose 2 Test Material + Tirzepatide (Coadministration)

Bimagrumab + Tirzepatide Coformulation DRUG

Administered SC

Also known as: LY900042

Bimagrumab Dose 1 Test Material + Tirzepatide (Coformulation); Bimagrumab Dose 2 Test Material + Tirzepatide (Coformulation)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

bimagrumab; Tirzepatide

Intervention Hierarchy (Ancestors)

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

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 24, 2025
• Study Start: March 25, 2025
• Primary Completion: September 26, 2025
• Study Completion: September 26, 2025
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)