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OpenTrials
Completed

NCT Number: NCT06890611

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

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.

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Key information

Conditions

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bimagrumab

Drug

Administered SC

Other names: LY3985863, BYM338, VER201

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Bimagrumab + Tirzepatide Coformulation

Drug

Administered SC

Other names: LY900042

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Bimagrumab Test Material

    Time frame: Predose through Week 13

  2. PK: Cmax of Bimagrumab Reference Material

    Time frame: Predose through Week 13

  3. PK: Cmax of Bimagrumab Coadministered with Tirzepatide

    Time frame: Predose through Week 13

  4. PK: Cmax of Tirzepatide Coadministered with Bimagrumab

    Time frame: Predose through Week 16

  5. PK: Cmax of Bimagrumab Coformulated with Tirzepatide

    Time frame: Predose through Week 16

  6. PK: Cmax of Tirzepatide Coformulated with Bimagrumab

    Time frame: Predose through Week 16

  7. PK: Area Under the Curve from Zero to Infinity AUC (AUC(0-∞)) of Bimagrumab Test Material

    Time frame: Predose through Week 13

  8. PK: AUC(0-∞) of Bimagrumab Reference Material

    Time frame: Predose through Week 13

  9. PK: AUC(0-∞) of Bimagrumab Coadministered with Tirzepatide

    Time frame: Predose through Week 13

  10. PK: AUC(0-∞) of Tirzepatide Coadministered with Bimagrumab

    Time frame: Predose through Week 16

  11. PK: AUC(0-∞) of Bimagrumab Coformulated with Tirzepatide

    Time frame: Predose through Week 16

  12. PK: AUC(0-∞) of Tirzepatide Coformulated with Bimagrumab

    Time frame: Predose through Week 16

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 24, 2025
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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