Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04559568 | A Study of LY3522348 in Healthy Participants | PHASE1 | COMPLETED | 65 | — | — | Oct 15, 2020 | Aug 17, 2021 | Nov 4, 2025 | 1 | United States |
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...