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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Bimagrumab + Tirzepatide Coformulation; Drug: Tirzepatide; Drug: Bimagrumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06890611

J4Z-MC-GIDG (Other Identifier)

27286

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 5 patient groups

Bimagrumab Dose 1 Reference Material

Experimental group

Description:

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

Treatment:

Drug: Bimagrumab

Bimagrumab Dose 1 Test Material + Tirzepatide (Coadministration)

Experimental group

Description:

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

Treatment:

Drug: Bimagrumab

Drug: Tirzepatide

Bimagrumab Dose 1 Test Material + Tirzepatide (Coformulation)

Experimental group

Description:

Participants will receive a single dose of bimagrumab with tirzepatide SC

Treatment:

Drug: Bimagrumab + Tirzepatide Coformulation

Bimagrumab Dose 2 Test Material + Tirzepatide (Coadministration)

Experimental group

Description:

Participants will receive bimagrumab SC and tirzepatide SC for 4 weeks

Treatment:

Drug: Bimagrumab

Drug: Tirzepatide

Bimagrumab Dose 2 Test Material + Tirzepatide (Coformulation)

Experimental group

Description:

Participants will receive bimagrumab with tirzepatide SC for 4 weeks

Treatment:

Drug: Bimagrumab + Tirzepatide Coformulation