Evaluating Bimagrumab Alone and With Tirzepatide 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
This study is testing how the drug bimagrumab works on its own and with tirzepatide in healthy people to see how they interact in the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Drugs / interventions | bimagrumab |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06890611 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the concentration levels of bimagrumab when administered alone and in combination with tirzepatide in healthy individuals. Participants will undergo a screening process and will be monitored over a period of approximately 4.5 months, which includes follow-up evaluations. The study focuses on understanding how these medications interact in the body and their pharmacokinetics. Healthy participants with a specific BMI range will be recruited for this trial.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals with a BMI between 22.0 and 30.0 kg/m2.
Not a fit: Patients with a history of pancreatitis, hepatitis, or significant weight fluctuations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the pharmacokinetics of bimagrumab and its combination with tirzepatide, potentially leading to improved treatment strategies for conditions related to metabolic health.
How similar studies have performed: While this specific combination has not been extensively tested, similar pharmacokinetic studies have shown promise in understanding drug interactions and effects.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- Fortrea Clinical Research Unit — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: This is a single site clinical trial 1-877-CTLILLY (1-877-285-4559) or
- Email: clinical_inquiry_hub@lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.