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)

NCT07867340 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27937J7V-MC-EOBB
• Study Type: interventional
• Target: 96
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

C-Reactive Protein

Outcome Measures

Primary Outcomes (2)

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

  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

  Baseline up to Follow up (Days 12 and 24)

Secondary Outcomes (1)

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

  Baseline up to End of Treatment (Day 17)

Study Arms (10)

LY5625573 Part A - Single Dose Healthy

EXPERIMENTAL

Single dose of LY5625573 administered orally in healthy participants

Drug: LY5625573

Placebo Part A - Single Dose Healthy

PLACEBO COMPARATOR

Single dose of Placebo administered orally in healthy participants

Drug: Placebo

LY5625573 + Midazolam Part B - Multiple Dose Healthy

EXPERIMENTAL

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

Drug: LY5625573; Drug: Midazolam

Placebo + Midazolam Part B - Multiple Dose Healthy

PLACEBO COMPARATOR

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

Drug: Midazolam; Drug: Placebo

LY5625573 Part C - Multiple Dose Elevated hsCRP

EXPERIMENTAL

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

Drug: LY5625573

Placebo Part C - Multiple Dose Elevated hsCRP

PLACEBO COMPARATOR

Multiple doses of Placebo administered orally in participants with elevated hsCRP

Drug: Placebo

LY5625573 Part D - Healthy Japanese

EXPERIMENTAL

MAD of LY5625573 administered orally in healthy Japanese participants

Drug: LY5625573

Placebo Part D - Healthy Japanese

PLACEBO COMPARATOR

Multiple doses of Placebo administered orally in healthy Japanese participants

Drug: Placebo

LY5625573 Part E - Healthy Chinese

EXPERIMENTAL

MAD of LY5625573 administered orally in healthy Chinese participants

Drug: LY5625573

Placebo Part E - Healthy Chinese

PLACEBO COMPARATOR

Multiple doses of Placebo administered orally in healthy Chinese participants

Drug: Placebo

Interventions

LY5625573 DRUG

Administered orally as tablet

Also known as: VTX3232

LY5625573 + Midazolam Part B - Multiple Dose Healthy; LY5625573 Part A - Single Dose Healthy; LY5625573 Part C - Multiple Dose Elevated hsCRP; LY5625573 Part D - Healthy Japanese; LY5625573 Part E - Healthy Chinese

Midazolam DRUG

Administered orally

LY5625573 + Midazolam Part B - Multiple Dose Healthy; Placebo + Midazolam Part B - Multiple Dose Healthy

Placebo DRUG

Administered orally as tablet

Placebo + Midazolam Part B - Multiple Dose Healthy; Placebo Part A - Single Dose Healthy; Placebo Part C - Multiple Dose Elevated hsCRP; Placebo Part D - Healthy Japanese; Placebo Part E - Healthy Chinese

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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\[Day 2 for Part B\]

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Collaborative Neuroscience Network - CNS

Los Alamitos, California, 90720, United States

Location

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Location

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); SG (1)