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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06890611
Enrollment
125
Registered
2025-03-24
Start date
2025-03-25
Completion date
2025-09-26
Last updated
2025-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGBimagrumab

Administered SC

DRUGTirzepatide

Administered SC

DRUGBimagrumab + Tirzepatide Coformulation

Administered SC

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Bimagrumab Test MaterialPredose through Week 13
PK: Cmax of Bimagrumab Reference MaterialPredose through Week 13
PK: Cmax of Bimagrumab Coadministered with TirzepatidePredose through Week 13
PK: Cmax of Tirzepatide Coadministered with BimagrumabPredose through Week 16
PK: Cmax of Bimagrumab Coformulated with TirzepatidePredose through Week 16
PK: Cmax of Tirzepatide Coformulated with BimagrumabPredose through Week 16
PK: Area Under the Curve from Zero to Infinity AUC (AUC(0-∞)) of Bimagrumab Test MaterialPredose through Week 13
PK: AUC(0-∞) of Bimagrumab Reference MaterialPredose through Week 13
PK: AUC(0-∞) of Bimagrumab Coadministered with TirzepatidePredose through Week 13
PK: AUC(0-∞) of Tirzepatide Coadministered with BimagrumabPredose through Week 16
PK: AUC(0-∞) of Bimagrumab Coformulated with TirzepatidePredose through Week 16
PK: AUC(0-∞) of Tirzepatide Coformulated with BimagrumabPredose through Week 16

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026