C-Reactive ProteinPhase 1NCT07867340

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 study testing LY5625573 and Midazolam in people with C-Reactive Protein, run by Eli Lilly and Company at 3 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: C-Reactive Protein
What is being tested?: LY5625573 and Midazolam
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 3 sitesin 2 countries
Study dates: Sep 2026to Jan 2027
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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]

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

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

Country

City, postcode or hospital

3 sites in 2 countries

United States2 sites

Fortrea Clinical Research Unit
Dallas, Texas, 75247
866-429-3700
Gene Voskuhl
Collaborative Neuroscience Network - CNS
Los Alamitos, California, 90720
Steven Reynolds

Other trials in United States

Singapore1 site

Lilly Centre for Clinical Pharmacology
Singapore, 138623
64139811
Jeffer Hann Wei Pang

Other trials in Singapore

About this study

Official title: A Phase 1, Randomized, Participant- and Investigator-Blinded, Placebo Controlled, Single-Dose and Multiple-Ascending Dose Study of Orally Administered LY5625573 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Participants, Including Japanese and Chinese Populations, and in Participants With Elevated C-Reactive Protein

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
Being tested: LY5625573, Midazolam, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY5625573Drug
Also called VTX3232
Administered orally as tablet
MidazolamDrug
Administered orally
PlaceboDrug
Administered orally as tablet

Study groups in NCT07867340
Study group	Role	What they receive
LY5625573 Part A - Single Dose Healthy	Experimental	Single dose of LY5625573 administered orally in healthy participants Receives: Drug: LY5625573
Placebo Part A - Single Dose Healthy	Placebo comparator	Single dose of Placebo administered orally in healthy participants Receives: Drug: Placebo
LY5625573 + Midazolam Part B - Multiple Dose Healthy	Experimental	Multiple-ascending dose (MAD) of LY5625573 and midazolam co-administered orally in healthy participants Receives: 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 Receives: 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) Receives: Drug: LY5625573
Placebo Part C - Multiple Dose Elevated hsCRP	Placebo comparator	Multiple doses of Placebo administered orally in participants with elevated hsCRP Receives: Drug: Placebo
LY5625573 Part D - Healthy Japanese	Experimental	MAD of LY5625573 administered orally in healthy Japanese participants Receives: Drug: LY5625573
Placebo Part D - Healthy Japanese	Placebo comparator	Multiple doses of Placebo administered orally in healthy Japanese participants Receives: Drug: Placebo
LY5625573 Part E - Healthy Chinese	Experimental	MAD of LY5625573 administered orally in healthy Chinese participants Receives: Drug: LY5625573
Placebo Part E - Healthy Chinese	Placebo comparator	Multiple doses of Placebo administered orally in healthy Chinese participants Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Measured: 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
Measured: Baseline up to Follow up (Days 12 and 24)

Secondary outcomes (1)

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY5625573
Measured: Baseline up to End of Treatment (Day 17)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2026Jan 2027

First posted9 Oct 2026
Study startSep 2026 (estimated)
Primary completionJan 2027 (estimated)
Study completionJan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for C-Reactive ProteinStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 96 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07867340
Sponsor's protocol ID: 27937
Other IDs: J7V-MC-EOBB
Status last verified: Oct 2026
First submitted: 5 Oct 2026
Last updated: 9 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

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

1-317-615-4559

LillyTrials@Lilly.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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