Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ZMG-3003936
LY5625575 · 1 trial · 2 indications
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Adverse Events module
| Arm | Type | Description |
|---|---|---|
| LY5625575 (Part A) - Single Dose Healthy | EXPERIMENTAL | Single escalating doses of LY5625575 administered orally in healthy participants. |
| Placebo (Part A) - Single Dose Healthy | PLACEBO_COMPARATOR | Single dose of placebo administered orally in healthy participants. |
| LY5625575 (Part B) - Multiple Dose Healthy | EXPERIMENTAL | Two or more doses of LY5625575 administered orally in healthy participants. |
| Placebo (Part B) - Multiple Dose Healthy | PLACEBO_COMPARATOR | Two or more doses of placebo administered orally in healthy participants. |
| 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). |
| Placebo (Part C) - Multiple Dose Elevated hsCRP | PLACEBO_COMPARATOR | Two or more doses of placebo administered orally in participants with elevated hsCRP. |
| LY5625575 (Part D) - Multiple Dose Healthy Japanese | EXPERIMENTAL | Two or more doses of LY5625575 administered orally in healthy Japanese participants. |
| Placebo (Part D) - Multiple Dose Healthy Japanese | PLACEBO_COMPARATOR | Two or more doses of placebo administered orally in healthy Japanese participants |
| LY5625575 (Part E) - Multiple Dose Healthy Chinese | EXPERIMENTAL | Two or more doses of LY5625575 administered orally in healthy Chinese participants. |
| Placebo (Part E) - Multiple Dose Healthy Chinese | PLACEBO_COMPARATOR | Two or more doses of placebo administered orally in healthy Chinese participants. |
| Name | Type | Description |
|---|---|---|
| LY5625575 | DRUG | Administered orally. |
| Placebo | DRUG | Administered orally. |
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 fir...
LY5625575 is an investigational small molecule developed by Eli Lilly and Company. It is being studied in healthy participants and in people with inflammation marked by elevated C-reactive protein. The drug is in Phase 1 clinical development and has not been approved for any use.
LY5625575 is being evaluated for inflammation associated with elevated C-reactive protein. The Phase 1 study enrolls both healthy volunteers and participants with elevated C-reactive protein. Because the drug remains investigational, no approved use has been established for LY5625575.
Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY, is developing LY5625575. Lilly is the sponsor of the Phase 1 study of the drug in healthy participants and participants with elevated C-reactive protein.
LY5625575 is in Phase 1 clinical development. One Phase 1 trial is currently recruiting, and no Phase 2 or later studies have been completed. The drug is investigational and has not received FDA approval.
LY5625575 is being studied in NCT07801300, titled A Study of LY5625575 in Healthy Participants and in Participants With Inflammation (Elevated C-Reactive Protein). The Phase 1 trial is recruiting in the United States, plans to enroll 204 participants, and is randomized, double blind, and placebo controlled.