A Study of Eltrekibart (LY3041658) in Healthy Participants

September 17, 2026 updated by: Eli Lilly and Company

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 138623
        • Lilly Centre for Clinical Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eltrekibart Cohort 1
Eltrekibart administered subcutaneously (SC)
Drug: LY3041658
Administered SC
Other Names:
  • Eltrekibart
Drug: LY3041658
Administered IV
Other Names:
  • Eltrekibart
Experimental: Eltrekibart Cohort 2
Eltrekibart administered SC
Drug: LY3041658
Administered SC
Other Names:
  • Eltrekibart
Drug: LY3041658
Administered IV
Other Names:
  • Eltrekibart
Experimental: Eltrekibart Cohort 3
Eltrekibart administered intravenously (IV)
Drug: LY3041658
Administered SC
Other Names:
  • Eltrekibart
Drug: LY3041658
Administered IV
Other Names:
  • Eltrekibart
Experimental: Eltrekibart Cohort 4
Eltrekibart administered SC
Drug: LY3041658
Administered SC
Other Names:
  • Eltrekibart
Drug: LY3041658
Administered IV
Other Names:
  • Eltrekibart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658
Time Frame: Predose on Day 1 up to Day 85
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
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
Predose on Day 1 up to Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 17, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 27485
  • I7P-MC-DSAI (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe