Can a new pill quiet inflammation? a trial puts it to the test

NCT ID NCT07801300

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This phase 1 trial evaluates the safety and tolerability of an experimental oral drug called LY5625575 in healthy volunteers, including Japanese and Chinese participants, and in people with elevated C-reactive protein, a marker of inflammation. Researchers will also measure how much of the drug enters the bloodstream and how quickly the body clears it. Participants receive either the drug or a placebo, and the study lasts seven to nine weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY5625575, an experimental oral drug
What this could lead to
If safe and well-tolerated, LY5625575 could become a candidate for treating conditions driven by inflammation.
What could go wrong
This is an early phase 1 trial focused on safety, not effectiveness. The drug may cause side effects or fail to show promise in later studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 204 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * All Parts: * Individuals not of childbearing potential may participate in this trial. * Individuals assigned male at birth may participate in this trial. * Healthy as defined by * the absence of clinically significant illness and surgery within 35 days prior to first dosing, and * the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease. * Part A: \-- Have an estimated glomerular filtration rate (eGFR), using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation 2021, of greater than or equal to (≥)90 milliliters per minute per 1.73 square meters (mL/min/1.73 m²) at screening. * Parts B, C, D, and E: \-- Have an eGFR, using the CKD-EPI creatinine equation 2021, of ≥60 mL/minute/1.73 m² * Parts A, B, D, and E: \-- Have a body mass index ≥18.5 and less than (\<)32.0 kilograms per square meter (kg/m²) * Part C: * hsCRP ≥2 mg/L and ≤15 mg/L at screening and Day -1. * Have a body mass index ≥18.5 and \<40.0 m2. * Part D: \-- To qualify as a participant of the first-generation Japanese origin, the participant, the participant's biological parents, and all of the participants' biological grandparents must be of exclusive Japanese descent and born in Japan. * Part E: * To qualify as Chinese for the purpose of this study, all the participants' biological grandparents must be of exclusive Chinese descent and born in China. Exclusion Criteria: * All Parts: * Individuals of childbearing potential are excluded from the trial * Any clinically significant abnormal finding at physical examination at screening and/or Day -1. * Any clinically significant physical findings in the mouth or tongue (for example, difficulty swallowing) that would be likely to interfere with oral administration of study intervention. * History of significant allergic reactions (for example, anaphylactic reaction, hypersensitivity, or angioedema) to any medication or known allergic reactions to drugs related to LY5625575, or to any excipient in the formulation. * History of active tuberculosis or presence of active or latent tuberculosis. * History or evidence of clinically significant opportunistic infection (for example, invasive candidiasis or pneumocystis pneumonia). * History of serious local infection (for example, cellulitis or abscess) or systemic infection (for example, septicemia) within 90 days prior to screening. * History of nonserious but active infections * History of more than one episode of herpes zoster infection or history of disseminated herpes zoster infection. * Presence or history of any abnormality or illness, which in the opinion of the investigator may affect absorption, distribution, metabolism, or elimination of the study intervention. * Are currently enrolled in a clinical study involving an investigational medicinal product (IMP) or any other type of medical research judged not to be scientifically or medically compatible with this study. * Are currently enrolled in or past participation within the 30 days prior to screening, in a clinical study involving a study intervention for which at least 5 half-lives or 30 days (whichever is longer) have not passed. * Have a 12-lead echocardiogram (ECG) abnormality that, in the opinion of the investigator, * increases the risks associated with participating in the study * may confound ECG data analysis * Have blood pressure and/or pulse rate constituting a risk when taking the investigational medicinal product, as determined by the investigator. * 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 * Positive pregnancy test or lactating participants assigned female at birth at screening and/or Day -1. * Positive drug screen, cotinine test, or alcohol test at screening and/or Day -1. * Any screening laboratory evaluation outside the laboratory reference range that is judged by the investigator to be clinically significant, with the exception of aspartate aminotransferase (AST), alanine aminotransferase (ALT), and/or total bilirubin (TBL) greater than (\>)upper limit of normal (ULN) for these laboratory parameters. * Presence of fever (body temperature \>37.6°C) (for example, a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to first dosing. * Use of medications for the timeframes specified below, with the exception of medications exempted by the investigator on a case-by-case basis because they are judged unlikely to affect the pharmacokinetic (PK) profile of the study intervention or participant safety (for example, topical drug products without significant systemic exposure): * depot injection or implant for 90 days prior to dosing * biologics for 90 days (or 5 half-lives, whichever is longer) prior to first dosing * live attenuated vaccines for 30 days prior to dosing * prescription medications or over-the-counter (OTC) medications and natural health products (including herbal remedies such as St. John's wort, homeopathic and traditional medicines, probiotics, food supplements such as amino acids, essential fatty acids, and protein supplements used in sports, with the exception of vitamins and minerals) for 14 days (or 5 half-lives, whichever is longer) prior to dosing (acetaminophen ≤3 grams/day will be permitted), or * any vaccine, including coronavirus disease 2019 (COVID-19) vaccine, for 14 days prior to dosing. * History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine, crack, opioid derivatives including heroin, and amphetamine derivatives) within 90 days prior to screening. * Any use of tobacco and/or nicotine product within 90 days prior to screening. * Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator. * Have donated blood of more than 500 mL within the previous 90 days of screening or intend to donate blood during the course of the study. * Parts B, C, D, and E: * Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide. * 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) OR * Have answered "yes" to any of the suicide-related behaviors on the "Suicidal Behavior" portion of the C-SSRS and the behavior occurred within the past 90 days (at screening and/or Day -1). NOTE: Non-suicidal self-injurious behavior is not considered a suicide-related behavior. * Have a baseline Patient Health Questionnaire-9 (PHQ-9) score of 15 or greater, and/or a score of 2 or greater for either

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fortrea Clinical Research Unit

    Dallas, Texas, 75247, United States

  • Syneos Health

    Miami, Florida, 33136, United States

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