Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3202328 · 1 trial · 1 indication
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...
LY3202328 is an investigational small molecule being developed for dyslipidemias, a group of disorders characterized by abnormal levels of lipids in the blood. It is being studied in the cardiovascular therapeutic area. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
LY3202328 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of dyslipidemias.
LY3202328 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies such as the FDA. The drug is being studied for its potential use in treating dyslipidemias, and its safety and tolerability are being evaluated in early-stage clinical trials.
LY3202328 has been studied in one clinical trial, identified as NCT02714569, titled 'A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia'. This Phase 1 trial was completed and enrolled 60 participants in the United States. The study was randomized, double-blind, and placebo-controlled, and it included healthy volunteers.
LY3202328 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of dyslipidemias. The drug has been evaluated in a completed clinical trial, but it has not yet received regulatory approval for marketing or use in patients.