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 being developed by Eli Lilly and Company. It is currently in Phase 1 clinical development. The drug has been studied in healthy participants, and its therapeutic area is classified as Other. As of now, it remains investigational and has not been approved for any use.
LY3478045 is being studied for use in healthy participants. The completed Phase 1 trial, NCT04270370, enrolled 72 healthy volunteers in the United States. The drug's specific intended indication has not been established, as it is still in early-stage clinical development.
LY3478045 is developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational small molecule in healthy participants.
LY3478045 is in Phase 1 clinical development. A single Phase 1 trial, NCT04270370, has been completed. This trial was a randomized, double-blind, placebo-controlled study involving 72 healthy participants in the United States. The drug is investigational and has not received FDA approval.
LY3478045 has one completed clinical trial, NCT04270370, titled "A Study of LY3478045 in Healthy Participants." This Phase 1 study enrolled 72 healthy volunteers aged 18 years and older in the United States. The trial was randomized, double-blind, and placebo-controlled, and it has been completed.