PROMINENT

Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes

Objective

The primary scientific aim of the PROMINENT study is to assess whether treatment with the SPPARM-α, K-877 (pemafibrate), will prevent MI, ischemic stroke, unstable angina requiring unplanned revascularization, and CV death in participants with T2D who have elevated TGs and HDL-C levels and are at high risk for future CV events. Participants will be on moderate- to high-intensity statin therapy (atorvastatin ≥ 40 mg/day, rosuvastatin ≥ 20 mg/day, simvastatin ≥ 40 mg/day, or pitavastatin 4 mg/day) or meet LDL-C criteria (by chart review) within 12 months prior to enrollment.

Specifically, the primary objective of the study is to determine whether pemafibrate administered at a dose of 0.2 mg twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of:

• Nonfatal MI
• Nonfatal ischemic stroke
• Hospitalization for unstable angina requiring unplanned coronary revascularization, or
• CV death

Eligibility

1. Fasting TG ≥ 200 mg/dL (2.26 mmol/L) and < 500 mg/dL (5.65 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
2. HDL-C ≤ 40 mg/dL (1.03 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
3. Type 2 diabetes of longer than 12 weeks duration documented in medical records, for example: local laboratory evidence through medical record review of elevated HbA1c (≥ 6.5% [48 mmol/mol]), elevated plasma glucose (fasting ≥ 126 mg/dL [7.0 mmol/L], 2-hour ≥ 200 mg/dL [11.1 mmol/L] during oral glucose tolerance testing, or random value ≥ 200 mg/dL with classic symptoms, or currently taking medication for treatment of diabetes