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

Registration

Registration

NCT06890611

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

125

Start

2025-03-25

Primary completion

2025-09-26

Lead sponsor

Eli Lilly and Company

Conditions

Healthy

Interventions

DRUG:Bimagrumab; DRUG:Tirzepatide; DRUG:Bimagrumab + Tirzepatide Coformulation

Results posted

FALSE

Individual participant data sharing

NO

Secondary identifiers

OTHER:J4Z-MC-GIDG

Registered primary outcomes

• 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]