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Not yet recruitingNCT07867340Updated Oct 9, 2026

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)

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

Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • C-Reactive Protein
03

In context

Lead sponsor

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.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 21 to 65 years of age, inclusive, at the time of signing the informed consent if enrolled in Singapore
  • Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring
  • Have clinical laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
  • Have a hemoglobin level of at least 12.5 grams per deciliter (g/dL) for participants assigned male at birth (AMAB) and at least 11.4 g/dL for participants assigned female at birth (AFAB)
  • Individuals AFAB who are individual not of childbearing potential (INOCBPs) may participate in this trial

Parts A, B, D, and E

  • Have a body mass index (BMI) greater than or equal to (≥)18.5 and less than or equal to (≤) 32.0 kilograms per square meter (kg/m²)
  • Have an estimated glomerular filtration rate (eGFR), using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation 2021, of ≥90 milliliter per minute per 1.73 square meters (mL)/minute/1.73 m² at screening

Part C

  • Have a BMI ≥18.5 and \<40.0 kg/m²
  • high-sensitivity C-reactive protein (hsCRP) ≥2 milligrams per liter (mg/L) and ≤15 mg/L at screening and Day -2 (as confirmed by local laboratory).
  • Have an eGFR, using the CKD-EPI creatinine equation 2021, of ≥60 mL/minute/1.73 m² at screening

Part D

  • To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan

Part E

  • To qualify as Chinese for this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China

Exclusion criteria

Exclusion Criteria:

  • History of active tuberculosis or presence of active or latent tuberculosis
  • History or evidence of clinically significant opportunistic infection
  • History of serious local infection (for example, cellulitis or abscess) or systemic infection within 90 days prior to screening
  • Have any nonserious but active infections
  • History of more than one episode of herpes zoster infection or history of disseminated herpes zoster infection
  • Have a 12-lead electrocardiogram (ECG) abnormality
  • Clinically significant abnormal laboratory test results at screening, or positive serology test results for hepatitis B surface antigen, hepatitis B core total antibody, hepatitis C virus antibody, or human immunodeficiency virus antigen and antibody, or QuantiFERON®-TB test at screening

Parts A, C, D, and E

  • History of significant allergic reactions to any medication or known allergic reactions to drugs related to LY5625573 (VTX3232) or to any excipient in the formulation of LY5625573

Part B

  • History of significant allergic reactions to any medication or known allergic reactions to drugs related to LY5625573 (VTX3232), midazolam, or to any excipient in the formulation of LY5625573 or midazolam

Parts B, C, D, and E

  • Have answered "yes" to either Question 4 or Question 5 on the "Suicidal Ideation" portion of the Columbia Suicide Severity Rating Scale (C-SSRS) and the ideation occurred within the past 90 days (at screening and/or Day -1 [Day 2 for Part B])
  • Have a baseline Patient Health Questionnaire-9 (PHQ-9) score of 15 or greater, and/or a score of 2 or greater for either of the first 2 questions on the PHQ-9 questionnaire (at Day -1[Day 2 for Part B]
05

Study design

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

Study arms

  • Experimental
    LY5625573 Part A - Single Dose Healthy

    Single dose of LY5625573 administered orally in healthy participants

    Drug: LY5625573

  • Placebo comparator
    Placebo Part A - Single Dose Healthy

    Single dose of Placebo administered orally in healthy participants

    Drug: Placebo

  • Experimental
    LY5625573 + Midazolam Part B - Multiple Dose Healthy

    Multiple-ascending dose (MAD) of LY5625573 and midazolam co-administered orally in healthy participants

    Drug: LY5625573 · Drug: Midazolam

  • Placebo comparator
    Placebo + Midazolam Part B - Multiple Dose Healthy

    Multiple doses of Placebo and midazolam co-administered orally in healthy participants

    Drug: Midazolam · Drug: Placebo

  • Experimental
    LY5625573 Part C - Multiple Dose Elevated hsCRP

    MAD of LY5625573 administered orally in participants with elevated high-sensitivity C-reactive protein (hsCRP)

    Drug: LY5625573

  • Placebo comparator
    Placebo Part C - Multiple Dose Elevated hsCRP

    Multiple doses of Placebo administered orally in participants with elevated hsCRP

    Drug: Placebo

  • Experimental
    LY5625573 Part D - Healthy Japanese

    MAD of LY5625573 administered orally in healthy Japanese participants

    Drug: LY5625573

  • Placebo comparator
    Placebo Part D - Healthy Japanese

    Multiple doses of Placebo administered orally in healthy Japanese participants

    Drug: Placebo

  • Experimental
    LY5625573 Part E - Healthy Chinese

    MAD of LY5625573 administered orally in healthy Chinese participants

    Drug: LY5625573

  • Placebo comparator
    Placebo Part E - Healthy Chinese

    Multiple doses of Placebo administered orally in healthy Chinese participants

    Drug: Placebo

Interventions

  • DrugLY5625573

    Administered orally as tablet

    Also known as: VTX3232

  • Administered orally

  • DrugPlacebo

    Administered orally as tablet

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

    Time frame: Baseline up to Follow up (Days 12 and 24)

  2. 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)

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY5625573

    Time frame: Baseline up to End of Treatment (Day 17)

07

Study locations

3 sites
  • Collaborative Neuroscience Network - CNS
    Los Alamitos, California 90720, United States
    • Steven Reynolds · Principal investigator
  • Fortrea Clinical Research Unit
    Dallas, Texas 75247, United States
    • · Contact · 866-429-3700
    • Gene Voskuhl · Principal investigator
  • Lilly Centre for Clinical Pharmacology
    Singapore, 138623, Singapore
    • · Contact · 64139811
    • Jeffer Hann Wei Pang · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07867340
Responsible party
Sponsor
First posted
Oct 9, 2026
Start date
Sep 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Oct 9, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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)
study director · Eli Lilly and Company

Oversight

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

Not currently enrolling

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

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