HealthyPhase 1NCT07545590
A Study of Eltrekibart (LY3041658) in Healthy Participants
A Phase 1 study testing LY3041658 in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
The main purpose of this study is to evaluate how eltrekibart is absorbed by the body when it is given under the skin to healthy participants. The study will last about 17 weeks. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3041658
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- 21 Apr 2026to 22 Sep 2026
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are overtly healthy as determined by medical evaluation including medical history and physical examination
- Have a minimum body weight of 45 kilograms (kg).
- Have a body mass index (BMI) within the range of 18.5 to 28.5 kilograms per square meter (kg/m²), inclusive
Who cannot join
- Have multiple severe allergies to prescription or nonprescription drugs
- Are immunocompromised
- Have had any of the following types of infection within 3 months prior to the screening visit:
- Serious, that is, requiring hospitalization, or intravenous or equivalent oral antibiotic treatment
- Opportunistic infections Note: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over
- Chronic, that is, duration of symptoms, signs, or treatment of 6 weeks or longer, or
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- Recurring, including, but not limited to:
- herpes simplex,
- herpes zoster,
- recurring cellulitis, or
- chronic osteomyelitis.
- Are currently pregnant or are intending to become pregnant or to breastfeed at any time in the study or within 16 weeks after receiving the single dose of study intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Single Dose Study to Investigate the Relative Bioavailability, Safety, and Tolerability of Two Formulations of Eltrekibart in Healthy Participants
The main purpose of this study is to evaluate how eltrekibart is absorbed by the body when it is given under the skin to healthy participants.
The study will last about 17 weeks.
- Conditions
- Healthy
- Being tested
- LY3041658
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3041658Drug
Also called Eltrekibart
Administered SC
LY3041658Drug
Also called Eltrekibart
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Eltrekibart Cohort 1 | Experimental | Eltrekibart administered subcutaneously (SC) Receives: Drug: LY3041658 |
| Eltrekibart Cohort 2 | Experimental | Eltrekibart administered SC Receives: Drug: LY3041658 |
| Eltrekibart Cohort 3 | Experimental | Eltrekibart administered intravenously (IV) Receives: Drug: LY3041658 |
| Eltrekibart Cohort 4 | Experimental | Eltrekibart administered SC Receives: Drug: LY3041658 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658
Measured: Predose on Day 1 up to Day 85
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of LY3041658
Measured: Predose on Day 1 up to Day 85
PK: Area Under the Concentration Versus Time Curve From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration AUC(0-tlast) of LY3041658
Measured: Predose on Day 1 up to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start21 Apr 2026
- Primary completion22 Sep 2026
- Study completion22 Sep 2026
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545590
- Sponsor's protocol ID
- 27485
- Other IDs
- I7P-MC-DSAI
- Status last verified
- Oct 2026
- First submitted
- 16 Apr 2026
- Last updated
- 6 Oct 2026
- 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single Dose Study to Investigate the Relative Bioavailability, Safety, and Tolerability of Two Formulations of Eltrekibart in Healthy Participants
- ClinicalTrials.gov ID
- NCT07545590
- Acronym / sponsor ID
- 27485
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 22 Sep 2026 (actual)
- Study completion
- 22 Sep 2026 (actual)
- First posted
- 22 Apr 2026 (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 how eltrekibart is absorbed by the body when it is given under the skin to healthy participants.
The study will last about 17 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eltrekibart Cohort 1 | Experimental | Drug: LY3041658Eltrekibart administered subcutaneously (SC) |
| Eltrekibart Cohort 2 | Experimental | Drug: LY3041658Eltrekibart administered SC |
| Eltrekibart Cohort 3 | Experimental | Drug: LY3041658Eltrekibart administered intravenously (IV) |
| Eltrekibart Cohort 4 | Experimental | Drug: LY3041658Eltrekibart administered SC |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Are overtly healthy as determined by medical evaluation including medical history and physical examination
- Have a minimum body weight of 45 kilograms (kg).
- Have a body mass index (BMI) within the range of 18.5 to 28.5 kilograms per square meter (kg/m²), inclusive
Key exclusion criteria (12 listed)
- Have multiple severe allergies to prescription or nonprescription drugs
- Are immunocompromised
- Have had any of the following types of infection within 3 months prior to the screening visit:
- Are currently pregnant or are intending to become pregnant or to breastfeed at any time in the study or within 16 weeks after receiving the single dose of study intervention.
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 |
|---|---|---|
| LY3041658Also: EltrekibartAdministered SC | Drug | Eltrekibart Cohort 1, Eltrekibart Cohort 2, Eltrekibart Cohort 4 |
| LY3041658Also: EltrekibartAdministered IV | Drug | Eltrekibart Cohort 3 |
Primary outcome
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658
Time frame: Predose on Day 1 up to Day 85
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of LY3041658
Time frame: Predose on Day 1 up to Day 85
PK: Area Under the Concentration Versus Time Curve From Time Zero to Time t, Where t is the Last Time Point With a Measurable Concentration AUC(0-tlast) of LY3041658
Time frame: Predose on Day 1 up to Day 85
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 6 Oct 2026.
- 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 8 AM - 8 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 LY3041658 in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
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 3 inclusion and 12 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 6 Oct 2026. 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 Singapore. 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 Observed Drug Concentration (Cmax) of LY3041658 (time frame: Predose on Day 1 up to Day 85). The study lists 3 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 6 Oct 2026.