A Study of LY5625575 in Healthy Participants and in Participants With Inflammation (Elevated C-Reactive Protein)

NCT07801300 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27948J8A-MC-EQBA
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 2

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of LY5625575 in healthy participants (including Japanese and Chinese) and in participants with high levels of a marker for inflammation (C-reactive protein). The study will also measure how much LY5625575 gets into the bloodstream and how long it takes the body to get rid of it. The study will last seven to nine weeks.

Conditions

Healthy Volunteers; C-Reactive Protein

Outcome Measures

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

  A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Adverse Events module

  Baseline up to Day 24

Secondary Outcomes (1)

• Pharmacokinetics (PK): Area under the Concentration Versus Time Curve (AUC) of LY5625575

  Day 1 Predose up to Day 17

Study Arms (10)

LY5625575 (Part A) - Single Dose Healthy

EXPERIMENTAL

Single escalating doses of LY5625575 administered orally in healthy participants.

Drug: LY5625575

Placebo (Part A) - Single Dose Healthy

PLACEBO COMPARATOR

Single dose of placebo administered orally in healthy participants.

Drug: Placebo

LY5625575 (Part B) - Multiple Dose Healthy

EXPERIMENTAL

Two or more doses of LY5625575 administered orally in healthy participants.

Drug: LY5625575

Placebo (Part B) - Multiple Dose Healthy

PLACEBO COMPARATOR

Two or more doses of placebo administered orally in healthy participants.

Drug: Placebo

LY5625575 (Part C) - Multiple Dose Elevated hsCRP

EXPERIMENTAL

Two or more doses of LY5625575 administered orally in participants with elevated high-sensitivity C-reactive protein (hsCRP).

Drug: LY5625575

Placebo (Part C) - Multiple Dose Elevated hsCRP

PLACEBO COMPARATOR

Two or more doses of placebo administered orally in participants with elevated hsCRP.

Drug: Placebo

LY5625575 (Part D) - Multiple Dose Healthy Japanese

EXPERIMENTAL

Two or more doses of LY5625575 administered orally in healthy Japanese participants.

Drug: LY5625575

Placebo (Part D) - Multiple Dose Healthy Japanese

PLACEBO COMPARATOR

Two or more doses of placebo administered orally in healthy Japanese participants

Drug: Placebo

LY5625575 (Part E) - Multiple Dose Healthy Chinese

EXPERIMENTAL

Two or more doses of LY5625575 administered orally in healthy Chinese participants.

Drug: LY5625575

Placebo (Part E) - Multiple Dose Healthy Chinese

PLACEBO COMPARATOR

Two or more doses of placebo administered orally in healthy Chinese participants.

Drug: Placebo

Interventions

LY5625575 DRUG

Administered orally.

Also known as: ZMG-3003936

LY5625575 (Part A) - Single Dose Healthy; LY5625575 (Part B) - Multiple Dose Healthy; LY5625575 (Part C) - Multiple Dose Elevated hsCRP; LY5625575 (Part D) - Multiple Dose Healthy Japanese; LY5625575 (Part E) - Multiple Dose Healthy Chinese

Placebo DRUG

Administered orally.

Placebo (Part A) - Single Dose Healthy; Placebo (Part B) - Multiple Dose Healthy; Placebo (Part C) - Multiple Dose Elevated hsCRP; Placebo (Part D) - Multiple Dose Healthy Japanese; Placebo (Part E) - Multiple Dose 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:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Syneos Health

Miami, Florida, 33136, United States

Location

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Location

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: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)