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

NCT06890611
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Phase
Phase 1
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Recruitment status
Completed
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Participants
125
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Lead sponsor
Eli Lilly and Company
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Start date
2025-03-25
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Number of sites
1
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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.
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Short title
A Study of Bimagrumab Alone (LY3985863) and Bimagrumab With Tirzepatide (LY900042) in Healthy Participants
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2025-09-26
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First posted
2025-03-24
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Registry last updated
2025-10-09
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Primary completion date
2025-09-26
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Start date
2025-03-25
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Actual participants
125
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Participants
125
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06890611
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ClinicalTrials.gov ID
NCT06890611
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Basic science
Masking
No masking
Sources for study design
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  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Bimagrumab Test Material

    Timeframe: Predose through Week 13

  2. PK: Cmax of Bimagrumab Reference Material

    Timeframe: Predose through Week 13

  3. PK: Cmax of Bimagrumab Coadministered with Tirzepatide

    Timeframe: Predose through Week 13

  4. PK: Cmax of Tirzepatide Coadministered with Bimagrumab

    Timeframe: Predose through Week 16

  5. PK: Cmax of Bimagrumab Coformulated with Tirzepatide

    Timeframe: Predose through Week 16

  6. PK: Cmax of Tirzepatide Coformulated with Bimagrumab

    Timeframe: Predose through Week 16

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

    Timeframe: Predose through Week 13

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

    Timeframe: Predose through Week 13

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

    Timeframe: Predose through Week 13

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

    Timeframe: Predose through Week 16

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

    Timeframe: Predose through Week 16

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

    Timeframe: Predose through Week 16

Sources for outcomes
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Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
64 Years
Healthy volunteers
Yes

  • 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

  • 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
Sources for eligibility
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  • Fortrea Clinical Research UnitDallas, United States
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • J4Z-MC-GIDG
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Targets (4)