A Study of Single and Multiple Doses of LY5625573 in Healthy Participants, Including Japanese and Chinese Populations, and Participants With Inflammation (High C-Reactive Protein)

Conditions

• C-Reactive Protein

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• LY5625573 — DRUG
  Administered orally as tablet
• Midazolam — DRUG
  Administered orally
• Placebo — DRUG
  Administered orally as tablet

Study Details

The purpose of this study is to learn if LY5625573 is safe and how well it is tolerated in healthy participants, including Japanese and Chinese participants, and in participants with high levels of a marker for inflammation (C-reactive protein). The study will also look at how the body absorbs, breaks down, and clears the study drug (pharmacokinetics), how the study drug works in the body, and whether it interacts with certain other medications by affecting how the body processes them. Participation in the study will last up to approximately 7 weeks for Part A and 8.5 weeks for Parts B, C, D, and E. For each participant there will be one stay at the clinical research unit (CRU) lasting 5 nights for Part A, 18 nights for Parts B and C, and 17 nights for Parts D and E.

Key Dates

First listed

Oct 9, 2026

Start date

Sep 30, 2026

Status verified

Oct 2026

Primary completion

Jan 31, 2027

Completion

Jan 31, 2027

Study Design

Enrollment

96 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: LY5625573 Part A - Single Dose Healthy
  Single dose of LY5625573 administered orally in healthy participants
• Placebo Comparator: Placebo Part A - Single Dose Healthy
  Single dose of Placebo administered orally in healthy participants
• Experimental: LY5625573 + Midazolam Part B - Multiple Dose Healthy
  Multiple-ascending dose (MAD) of LY5625573 and midazolam co-administered orally in healthy participants
• Placebo Comparator: Placebo + Midazolam Part B - Multiple Dose Healthy
  Multiple doses of Placebo and midazolam co-administered orally in healthy participants
• Experimental: LY5625573 Part C - Multiple Dose Elevated hsCRP
  MAD of LY5625573 administered orally in participants with elevated high-sensitivity C-reactive protein (hsCRP)
• Placebo Comparator: Placebo Part C - Multiple Dose Elevated hsCRP
  Multiple doses of Placebo administered orally in participants with elevated hsCRP
• Experimental: LY5625573 Part D - Healthy Japanese
  MAD of LY5625573 administered orally in healthy Japanese participants
• Placebo Comparator: Placebo Part D - Healthy Japanese
  Multiple doses of Placebo administered orally in healthy Japanese participants
• Experimental: LY5625573 Part E - Healthy Chinese
  MAD of LY5625573 administered orally in healthy Chinese participants
• Placebo Comparator: Placebo Part E - Healthy Chinese
  Multiple 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 Follow up (Days 12 and 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)

Find similar trials in Los Alamitos, CA

Related Studies

• A Study of LY5625575 in Healthy Participants and in Participants With Inflammation (Elevated C-Reactive Protein)
  PHASE1 · Recruiting · Eli Lilly and Company · Miami, Florida
• What is the Effect of Increased Consumption of Fruit Juice on Exercise Capacity and Inflammatory Biomarkers?
  Recruiting · Northwell Health · New York, New York