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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02714569 | A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia | PHASE1 | COMPLETED | 60 | — | — | Mar 1, 2016 | Feb 15, 2017 | May 25, 2021 | 4 | United States |
Number of participants with one or more SAEs in Part A and Part B. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
| Arm | Type | Description |
|---|---|---|
| Part A: LY3202328 (LY) | EXPERIMENTAL | Single ascending doses of 1 milligram (mg), 3 mg, 10 mg, 30 mg, 100 mg, 300mg, 600 mg LY3202328 orally while fasting, or 30 mg LY3202328 orally while fed in 4 periods. |
| Part A: Placebo | PLACEBO_COMPARATOR | A single ascending dose of placebo orally, in 1 period while fasting, and up to one period while fed. |
| Part B: LY3202328 (LY) | EXPERIMENTAL | A multiple ascending dose of 5 mg, 20 mg, 100 mg, and 300 mg LY3202328 at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (atorvastatin or simvastatin) one week prior to treatment and on Day 29. |
| Part B: Placebo | PLACEBO_COMPARATOR | A multiple ascending dose of placebo at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (atorvastatin or simvastatin) one week prior to treatment and on Day 29. |
| Name | Type | Description |
|---|---|---|
| LY3202328 | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| Atorvastatin | DRUG | Administered orally |
| Simvastatin | DRUG | Administered orally |
Inclusion Criteria: * Be healthy, as determined by medical history and physical examination * Male participants must be between 18 and 70 years of age and must agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product * Fema...