A Phase 1 interventional study of LY5625573 and Midazolam in C-Reactive Protein, sponsored by Eli Lilly and Company. Not yet recruiting at 3 sites in 2 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
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.
Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.
Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.
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Parts A, B, D, and E
Part C
Part D
Part E
Exclusion Criteria:
Parts A, C, D, and E
Part B
Parts B, C, D, and E
Single dose of LY5625573 administered orally in healthy participants
Drug: LY5625573
Single dose of Placebo administered orally in healthy participants
Drug: Placebo
Multiple-ascending dose (MAD) of LY5625573 and midazolam co-administered orally in healthy participants
Drug: LY5625573 · Drug: Midazolam
Multiple doses of Placebo and midazolam co-administered orally in healthy participants
Drug: Midazolam · Drug: Placebo
MAD of LY5625573 administered orally in participants with elevated high-sensitivity C-reactive protein (hsCRP)
Drug: LY5625573
Multiple doses of Placebo administered orally in participants with elevated hsCRP
Drug: Placebo
MAD of LY5625573 administered orally in healthy Japanese participants
Drug: LY5625573
Multiple doses of Placebo administered orally in healthy Japanese participants
Drug: Placebo
MAD of LY5625573 administered orally in healthy Chinese participants
Drug: LY5625573
Multiple doses of Placebo administered orally in healthy Chinese participants
Drug: Placebo
Administered orally as tablet
Also known as: VTX3232
Administered orally
Administered orally as tablet
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)
Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline up to Follow up (Days 12 and 24)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY5625573
Time frame: Baseline up to End of Treatment (Day 17)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Midazolam