Clinical trial NCT06890611: A Study of Bimagrumab Alone (LY3985863) and Bimagrumab With Tirzepatide (LY900042) in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-03-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Bimagrumab Test Material
timeFrame: Predose through Week 13
measure: PK: Cmax of Bimagrumab Reference Material
timeFrame: Predose through Week 13
measure: PK: Cmax of Bimagrumab Coadministered with Tirzepatide
timeFrame: Predose through Week 13
measure: PK: Cmax of Tirzepatide Coadministered with Bimagrumab
timeFrame: Predose through Week 16
measure: PK: Cmax of Bimagrumab Coformulated with Tirzepatide
timeFrame: Predose through Week 16
measure: PK: Cmax of Tirzepatide Coformulated with Bimagrumab
timeFrame: Predose through Week 16
measure: PK: Area Under the Curve from Zero to Infinity AUC (AUC(0-∞)) of Bimagrumab Test Material
timeFrame: Predose through Week 13
measure: PK: AUC(0-∞) of Bimagrumab Reference Material
timeFrame: Predose through Week 13
measure: PK: AUC(0-∞) of Bimagrumab Coadministered with Tirzepatide
timeFrame: Predose through Week 13
measure: PK: AUC(0-∞) of Tirzepatide Coadministered with Bimagrumab
timeFrame: Predose through Week 16
measure: PK: AUC(0-∞) of Bimagrumab Coformulated with Tirzepatide
timeFrame: Predose through Week 16
measure: PK: AUC(0-∞) of Tirzepatide Coformulated with Bimagrumab
timeFrame: Predose through Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Fortrea Clinical Research Unit
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: