Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3478045 · 1 trial · 1 indication
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is reported in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| LY3478045 (Part A) | EXPERIMENTAL | Participants received single ascending oral dose of 20 milligram (mg), 60mg, 180 mg, 500 mg, 700 mg LY3478045 on Day 1. |
| Placebo (Part A) | PLACEBO_COMPARATOR | Participants received single oral dose of placebo on Day 1. |
| LY3478045 (Part B) | EXPERIMENTAL | Participants received multiple ascending oral dose of 60mg and 300 mg LY3478045 once-daily (QD)for 14 days. |
| Placebo (Part B) | PLACEBO_COMPARATOR | Participants received oral dose of placebo QD for 14 days. |
| LY3478045 + Atorvastatin (Part B) | EXPERIMENTAL | Participants received multiple ascending oral doses of 160 mg, 360 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7. |
| Placebo + Atorvastatin (Part B) | PLACEBO_COMPARATOR | Participants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7. |
| Name | Type | Description |
|---|---|---|
| LY3478045 | DRUG | Administered orally. |
| Placebo | DRUG | Administered orally. |
| Atorvastatin | DRUG | Administered orally. |
Inclusion Criteria: * Are overtly healthy participants as determined through medical history and physical examination * Have a body mass index greater than or equal to (≥)18.5 and less than or equal to (≤)40 kilograms per square meter (kg/m²) * Have had a stable weight for 3 months prior to screeni...
LY3478045 is an investigational small molecule developed by Eli Lilly and Company. It has been studied in a Phase 1 clinical trial in healthy adult participants. The specific disease or condition it is intended to treat has not been disclosed, and it remains in early clinical development.
LY3478045 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the Phase 1 study of the compound conducted in the United States.
LY3478045 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound is investigational and has not been approved by the FDA for any indication.
LY3478045 has been evaluated in one Phase 1 trial, NCT04270370, titled A Study of LY3478045 in Healthy Participants. The trial enrolled 72 healthy adult volunteers in the United States, was randomized, double-blind, and placebo-controlled, and has been completed.
Yes. The completed Phase 1 trial of LY3478045, NCT04270370, enrolled 72 healthy adult participants aged 18 years and older of all sexes. The study was conducted in the United States and used a randomized, double-blind, placebo-controlled design.