A Study of LY5625575 in Healthy Participants and in Participants With Inflammation (Elevated C-Reactive Protein)

Part of paid clinical trials in Miami, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT07801300
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • C-Reactive Protein
  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • LY5625575 — DRUG
    Administered orally.
  • Placebo — DRUG
    Administered orally.

Study Details

The main purpose of this study is to evaluate the safety and tolerability of LY5625575 in healthy participants (including Japanese and Chinese) and in participants with high levels of a marker for inflammation (C-reactive protein). The study will also measure how much LY5625575 gets into the bloodstream and how long it takes the body to get rid of it. The study will last seven to nine weeks.

Key Dates

First listed
Sep 3, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
204 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: LY5625575 (Part A) - Single Dose Healthy
    Single escalating doses of LY5625575 administered orally in healthy participants.
  • Placebo Comparator: Placebo (Part A) - Single Dose Healthy
    Single dose of placebo administered orally in healthy participants.
  • Experimental: LY5625575 (Part B) - Multiple Dose Healthy
    Two or more doses of LY5625575 administered orally in healthy participants.
  • Placebo Comparator: Placebo (Part B) - Multiple Dose Healthy
    Two or more doses of placebo administered orally in healthy participants.
  • Experimental: LY5625575 (Part C) - Multiple Dose Elevated hsCRP
    Two or more doses of LY5625575 administered orally in participants with elevated high-sensitivity C-reactive protein (hsCRP).
  • Placebo Comparator: Placebo (Part C) - Multiple Dose Elevated hsCRP
    Two or more doses of placebo administered orally in participants with elevated hsCRP.
  • Experimental: LY5625575 (Part D) - Multiple Dose Healthy Japanese
    Two or more doses of LY5625575 administered orally in healthy Japanese participants.
  • Placebo Comparator: Placebo (Part D) - Multiple Dose Healthy Japanese
    Two or more doses of placebo administered orally in healthy Japanese participants
  • Experimental: LY5625575 (Part E) - Multiple Dose Healthy Chinese
    Two or more doses of LY5625575 administered orally in healthy Chinese participants.
  • Placebo Comparator: Placebo (Part E) - Multiple Dose Healthy Chinese
    Two or more doses of placebo administered orally in healthy Chinese participants.

Primary Outcome Measure

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline up to Day 24 ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (2)

FacilityCityStateZIPSite coordinators
Syneos HealthMiamiFlorida33136
305-547-5800
Monica Mauri (PRINCIPAL_INVESTIGATOR)
Fortrea Clinical Research UnitDallasTexas75247
214-647-9375
Archie Bowie (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
Syneos Health· Miami, FLFortrea Clinical Research Unit· Dallas, TX

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