CClinicalTrials.gg
CompletedNCT06007638Updated Sep 24, 2025

A Single and Multiple Ascending Dose Study of LY3876602 in Healthy Participants

A Phase 1 interventional study of LY3876602 and Placebo in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-24.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The aim of this study is to evaluate the safety, tolerability and PK of LY3876602 after administering it as single ascending doses and, following a data review, proceeding to multiple ascending doses in healthy participants. Blood tests will also be performed to check how much LY3876602 gets into the bloodstream and cerebrospinal fluid (CSF) and how long it takes the body to eliminate it.

Following the screening visit for Part A, the study will last up to approximately 20 weeks., and a subgroup of participants will consent to CSF collections The study will last up to approximately 28 weeks for Part B. All participants will consent to CSF collections.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male and female participants who are overtly healthy as determined by medical evaluation
  • Have a body mass index with the range of 18 and less than or equal to (≤) 32 kilograms per square meter (kg/m²)
  • Male or female participants of nonchildbearing potential

Exclusion criteria

Exclusion Criteria:

  • Have a family history, defined as a parent or first-degree relative, of genetic neurodegenerative disorders
  • Have allergies to diphenhydramine, epinephrine, or methylprednisolone
  • Have serious or unstable medical conditions,
  • History of skin wounding within 14 days of screening or current skin infection
  • Are unwilling to stop alcohol consumption 48 hours prior to each dosing
  • Have active or latent tuberculosis
  • Participants in the cohorts undergoing lumbar puncture have an allergy to local anesthetics
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    LY3876602

    Single ascending doses of LY3876602 administered intravenously (IV).

    Drug: LY3876602

  • Placebo comparator
    Placebo

    Placebo administered IV.

    Drug: Placebo

  • Experimental
    LY3876602 Part B (MAD)

    Multiple ascending doses of LY3876602 will be administered intravenously (IV).

    Drug: LY3876602

  • Placebo comparator
    Placebo: Part B (MAD)

    Placebo administered IV

    Drug: Placebo

Interventions

  • DrugLY3876602

    Administered IV.

  • DrugPlacebo

    Administered IV.

06

What researchers measure

Primary outcomes

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

    Time frame: Baseline up to 28 weeks

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3876602

    PK: AUC of LY3876602

    Time frame: Predose up to 28 weeks

  2. PK: Maximum Observed Drug Concentration (Cmax) of LY3876602

    PK: Cmax of LY3876602

    Time frame: Predose up to 28 weeks

  3. PK: Half-life (t1/2) of LY3876602

    PK: t1/2 of LY3876602

    Time frame: Predose up to 28 weeks

07

Study locations

1 site
  • ICON Early Phase Services, LLC
    Groningen, 9728 NZ, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06007638
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Aug 23, 2023
Start date
Aug 23, 2023
Primary completion
Sep 20, 2025
Completion
Sep 20, 2025
Last update
Sep 24, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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