Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3522348 · 1 trial · 1 indication
An SAE is any untoward medical occurrence temporally associated with the use of study intervention that results in death is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation as determined by investigator. The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported here. A summary of SAEs and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| Part A: Placebo | PLACEBO_COMPARATOR | A single dose of Placebo administered orally on Day 1. |
| Part A: 5 milligrams (mg) LY3522348 | EXPERIMENTAL | A single dose of 5 mg LY3522348 administered orally on Day 1. |
| Part A: 15 mg LY3522348 | EXPERIMENTAL | A single dose of 15 mg LY3522348 administered orally on Day 1. |
| Part A: 50 mg LY3522348 | EXPERIMENTAL | A single dose of 50 mg LY3522348 administered orally on Day 1. |
| Part A: 150 mg LY3522348 | EXPERIMENTAL | A single dose of 150 mg LY3522348 administered orally on Day 1. |
| Part A: 380 mg LY3522348 | EXPERIMENTAL | A single dose of 380 mg LY3522348 administered orally on Day 1. |
| Part B: Placebo | PLACEBO_COMPARATOR | Placebo administered orally once daily on Days 1-14. |
| Part B: Placebo + Midazolam | EXPERIMENTAL | Placebo administered orally once daily on Days 1-15 and a single dose of 200 micrograms (μg) Midazolam administered orally on Days -1 and 15. |
| Part B: 50 mg LY3522348 | EXPERIMENTAL | 50 mg LY3522348 administered orally once daily on Days 1-14. |
| Part B: 120 mg LY3522348 | EXPERIMENTAL | 120 mg LY3522348 administered orally once daily on Days 1-14. |
| Part B: 290 mg LY3522348 + Midazolam | EXPERIMENTAL | 290 mg LY3522348 administered orally once daily on Days 1-15 and a single dose of 200 μg Midazolam administered orally on Days -1 and 15. |
| Name | Type | Description |
|---|---|---|
| LY3522348 | DRUG | Administered orally. |
| Placebo | DRUG | Administered orally. |
| Midazolam | DRUG | Administered orally. |
Inclusion Criteria: * Are overtly healthy as determined through medical evaluation including medical history and physical examination * Have a body mass index of 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 one mo...
LY3522348 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. It is not approved and remains in clinical trials.
LY3522348 is being studied for use in healthy participants. The Phase 1 trial, NCT04559568, enrolled healthy volunteers to evaluate the drug. The indication is listed as Healthy, meaning the study is not targeting a specific disease. The drug is still in early clinical development.
LY3522348 is developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker LLY. The company is conducting clinical trials to evaluate this investigational small molecule in healthy participants.
LY3522348 is in Phase 1 clinical development. The only trial, NCT04559568, is a Phase 1 study that has been completed. The drug is investigational and has not been approved by regulatory authorities. It is still in the early stages of clinical testing.
LY3522348 has one completed clinical trial, NCT04559568, titled "A Study of LY3522348 in Healthy Participants." This Phase 1 study enrolled 65 participants in the United States. The trial was randomized, double-blind, and placebo-controlled, and it included healthy volunteers aged 18 years and older.