Ly5625575: safety and how the body handles the drug in healthy people and those with inflammation
Official title: A Phase 1, Randomized, Single-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of Orally Administered LY5625575 in Healthy Participants, Including Japanese and Chinese Populations, and in Participants With Elevated C-Reactive Protein
Run by Eli Lilly and Company · NCT07801300 · Data updated 2026-11-12
This study tests LY5625575 in healthy volunteers and in people with elevated C-reactive protein to see if it is safe, well-tolerated, and how it behaves in the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 204 (estimated) |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Status | Recruiting |
| Started | September 2, 2026 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07801300 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults (including Japanese and Chinese individuals) without significant illnesses, plus adults with elevated CRP and adequate kidney function, BMI between 18.5 and 32.
✕Probably not a fit
Participants with significant comorbidities or organ dysfunction that disqualify them from trial safety criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1 interventional trial evaluating LY5625575 in two cohorts: healthy participants and those with higher inflammation as indicated by C-reactive protein. The study aims to characterize safety, tolerability, and pharmacokinetics, including how much drug enters the bloodstream and how quickly it is cleared. Part ranges include Japanese and Chinese healthy volunteers, with several eligibility criteria focusing on kidney function and BMI. The trial lasts approximately seven to nine weeks and includes placebo control in addition to the active drug. Locations include Syneos Health in Miami and Fortrea Clinical Research Unit in Dallas, under Eli Lilly and Company as lead sponsor.
Why it matters
Potential benefit: If successful, participants could tolerate LY5625575 well and the data may support further development for inflammatory-related indications.
How similar studies have gone: Phase 1 trials of similar anti-inflammatory agents often show safety and PK data; this study builds on established Phase 1 approaches but LY5625575 is novel in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 in a clinical study involving a study intervention for which at least 5 half-lives or 30 days (whichever is longer) have not passed prior to screening.
* Participation in a clinical study involving an investigational medicinal product (IMP) with an unknown half-life within the 12 months prior to screening.
* 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
Where it's running
-
Syneos Health
Miami, Florida, United States Recruiting -
Fortrea Clinical Research Unit
Dallas, Texas, United States Not yet recruiting
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.