NCT03071692

Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10,544 (actual)
• Sponsor: Kowa Research Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to determine whether pemafibrate administered twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of: * nonfatal Myocardial Infarction (MI) * nonfatal ischemic stroke * coronary revascularization; or * Cardio Vascular (CV) death.

Detailed description

A multi-regional clinical trial with participating sites in the following countries. India is being conducted under a previous protocol version due to regulatory requirements. * Argentina * Brazil * Bulgaria * Canada * Colombia * Czech Republic * Denmark * France * Germany * Hungary * India * Israel * Japan * Mexico * Netherlands * Poland * Romania * Russian Federation * Slovakia * South Africa * Spain * Ukraine * United Kingdom * United States

Conditions

• Type2 Diabetes
• Dyslipidemia

Interventions

Type	Name	Description
DRUG	K-877	0.2mg tablet
DRUG	Placebo	K-877 matching placebo tablet

Timeline

• Start date: 2017-03-23
• Primary completion: 2022-07-27
• Completion: 2022-07-27
• First posted: 2017-03-07
• Last updated: 2025-09-25
• Results posted: 2025-09-25

Locations

888 sites across 25 countries: United States, Argentina, Brazil, Bulgaria, Canada, Colombia, Czechia, Denmark, France, Germany, Hungary, India, Israel, Japan, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russia, Slovakia, South Africa, Spain, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study