A Study of Eltrekibart (LY3041658) in Healthy Participants

NCT07545590 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27485I7P-MC-DSAI
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658

  Predose on Day 1 up to Day 85

• PK: Area Under the Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of LY3041658

  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

  Predose on Day 1 up to Day 85

Study Arms (4)

Eltrekibart Cohort 1

EXPERIMENTAL

Eltrekibart administered subcutaneously (SC)

Drug: LY3041658

Eltrekibart Cohort 2

EXPERIMENTAL

Eltrekibart administered SC

Drug: LY3041658

Eltrekibart Cohort 3

EXPERIMENTAL

Eltrekibart administered intravenously (IV)

Drug: LY3041658

Eltrekibart Cohort 4

EXPERIMENTAL

Eltrekibart administered SC

Drug: LY3041658

Interventions

LY3041658 DRUG

Administered SC

Also known as: Eltrekibart

Eltrekibart Cohort 1; Eltrekibart Cohort 2; Eltrekibart Cohort 4

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Study Officials

• 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 DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)