HealthyPhase 1NCT06890611
A Study of Bimagrumab Alone (LY3985863) and Bimagrumab With Tirzepatide (LY900042) in Healthy Participants
A Phase 1 study testing Bimagrumab, Tirzepatide and Bimagrumab + Tirzepatide Coformulation in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Bimagrumab, Tirzepatide and Bimagrumab + Tirzepatide Coformulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2025to 26 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy
- Being tested
- Bimagrumab, Tirzepatide, Bimagrumab + Tirzepatide Coformulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimagrumabDrug
Also called LY3985863, BYM338, VER201
Administered SC
TirzepatideDrug
Also called LY3298176
Administered SC
Bimagrumab + Tirzepatide CoformulationDrug
Also called LY900042
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Bimagrumab Dose 1 Reference Material | Experimental | Participants will receive a single dose of bimagrumab subcutaneously (SC) Receives: Drug: Bimagrumab |
| Bimagrumab Dose 1 Test Material + Tirzepatide (Coadministration) | Experimental | Participants will receive a single dose of bimagrumab SC and a single dose of tirzepatide SC Receives: Drug: Bimagrumab; Drug: Tirzepatide |
| Bimagrumab Dose 1 Test Material + Tirzepatide (Coformulation) | Experimental | Participants will receive a single dose of bimagrumab with tirzepatide SC Receives: Drug: Bimagrumab + Tirzepatide Coformulation |
| Bimagrumab Dose 2 Test Material + Tirzepatide (Coadministration) | Experimental | Participants will receive bimagrumab SC and tirzepatide SC for 4 weeks Receives: Drug: Bimagrumab; Drug: Tirzepatide |
| Bimagrumab Dose 2 Test Material + Tirzepatide (Coformulation) | Experimental | Participants will receive bimagrumab with tirzepatide SC for 4 weeks Receives: Drug: Bimagrumab + Tirzepatide Coformulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Bimagrumab Test Material
Measured: Predose through Week 13
PK: Cmax of Bimagrumab Reference Material
Measured: Predose through Week 13
PK: Cmax of Bimagrumab Coadministered with Tirzepatide
Measured: Predose through Week 13
PK: Cmax of Tirzepatide Coadministered with Bimagrumab
Measured: Predose through Week 16
PK: Cmax of Bimagrumab Coformulated with Tirzepatide
Measured: Predose through Week 16
PK: Cmax of Tirzepatide Coformulated with Bimagrumab
Measured: Predose through Week 16
PK: Area Under the Curve from Zero to Infinity AUC (AUC(0-∞)) of Bimagrumab Test Material
Measured: Predose through Week 13
PK: AUC(0-∞) of Bimagrumab Reference Material
Measured: Predose through Week 13
PK: AUC(0-∞) of Bimagrumab Coadministered with Tirzepatide
Measured: Predose through Week 13
PK: AUC(0-∞) of Tirzepatide Coadministered with Bimagrumab
Measured: Predose through Week 16
PK: AUC(0-∞) of Bimagrumab Coformulated with Tirzepatide
Measured: Predose through Week 16
PK: AUC(0-∞) of Tirzepatide Coformulated with Bimagrumab
Measured: Predose through Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start25 Mar 2025
- Primary completion26 Sep 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890611
- Sponsor's protocol ID
- 27286
- Other IDs
- J4Z-MC-GIDG
- Status last verified
- Oct 2025
- First submitted
- 18 Mar 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06890611
- Acronym / sponsor ID
- 27286
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Bimagrumab Dose 1 Reference Material | Experimental | Drug: BimagrumabParticipants will receive a single dose of bimagrumab subcutaneously (SC) |
| Bimagrumab Dose 1 Test Material + Tirzepatide (Coadministration) | Experimental | Drug: Bimagrumab, Drug: TirzepatideParticipants will receive a single dose of bimagrumab SC and a single dose of tirzepatide SC |
| Bimagrumab Dose 1 Test Material + Tirzepatide (Coformulation) | Experimental | Drug: Bimagrumab + Tirzepatide CoformulationParticipants will receive a single dose of bimagrumab with tirzepatide SC |
| Bimagrumab Dose 2 Test Material + Tirzepatide (Coadministration) | Experimental | Drug: Bimagrumab, Drug: TirzepatideParticipants will receive bimagrumab SC and tirzepatide SC for 4 weeks |
| Bimagrumab Dose 2 Test Material + Tirzepatide (Coformulation) | Experimental | Drug: Bimagrumab + Tirzepatide CoformulationParticipants will receive bimagrumab with tirzepatide SC for 4 weeks |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BimagrumabAlso: LY3985863, BYM338, VER201Administered SC | Drug | Bimagrumab Dose 1 Reference Material, Bimagrumab Dose 1 Test Material + Tirzepatide (Coadministration), Bimagrumab Dose 2 Test Material + Tirzepatide (Coadministration) |
| TirzepatideAlso: LY3298176Administered SC | Drug | Bimagrumab Dose 1 Test Material + Tirzepatide (Coadministration), Bimagrumab Dose 2 Test Material + Tirzepatide (Coadministration) |
| Bimagrumab + Tirzepatide CoformulationAlso: LY900042Administered SC | Drug | Bimagrumab Dose 1 Test Material + Tirzepatide (Coformulation), Bimagrumab Dose 2 Test Material + Tirzepatide (Coformulation) |
Primary outcome
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Bimagrumab Test Material
Time frame: Predose through Week 13
PK: Cmax of Bimagrumab Reference Material
Time frame: Predose through Week 13
PK: Cmax of Bimagrumab Coadministered with Tirzepatide
Time frame: Predose through Week 13
PK: Cmax of Tirzepatide Coadministered with Bimagrumab
Time frame: Predose through Week 16
PK: Cmax of Bimagrumab Coformulated with Tirzepatide
Time frame: Predose through Week 16
PK: Cmax of Tirzepatide Coformulated with Bimagrumab
Time frame: Predose through Week 16
PK: Area Under the Curve from Zero to Infinity AUC (AUC(0-∞)) of Bimagrumab Test Material
Time frame: Predose through Week 13
PK: AUC(0-∞) of Bimagrumab Reference Material
Time frame: Predose through Week 13
PK: AUC(0-∞) of Bimagrumab Coadministered with Tirzepatide
Time frame: Predose through Week 13
PK: AUC(0-∞) of Tirzepatide Coadministered with Bimagrumab
Time frame: Predose through Week 16
PK: AUC(0-∞) of Bimagrumab Coformulated with Tirzepatide
Time frame: Predose through Week 16
PK: AUC(0-∞) of Tirzepatide Coformulated with Bimagrumab
Time frame: Predose through Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bimagrumab, Tirzepatide and Bimagrumab + Tirzepatide Coformulation in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Bimagrumab Test Material (time frame: Predose through Week 13). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.