A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double--Blind, 12-Week Study With a 40-Week, Active-Controlled, Open-Label Extension to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Mild or Moderate Renal Impairment
A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double--Blind, 12-Week Study With a 40-Week, Active-Controlled, Open-Label Extension to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Mild or Moderate Renal Impairment
The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients With Fasting High Triglyceride Levels ≥500 mg/dL and <2000 mg/dL and Mild or Moderate Renal Impairment.
Inclusion Criteria:
Able to understand and willing to comply with all study requirements and procedures throughout the duration of the study and give written informed consent;
Aged ≥18 years;
Patients receiving moderate- or high-intensity statin therapy must meet one of the following criteria¹ unless they have any exceptional conditions (see inclusion criterion 4):
Patients currently on a low-intensity statin or not on a statin, must meet one of the following criteria;
Fasting TG levels ≥500 mg/dL (5.65 mmol/L) and <2000 mg/dL (22.60 mmol/L) based on the mean of Visit 2 (Week -2) and Visit 3 (Week -1).
Exclusion Criteria:
Dallas, Texas 75216, United States
San Antonio, Texas 78228, United States
Minsk, 220045, Belarus
Pleven, 5800, Bulgaria
Pleven, 5800, Bulgaria
Plovdiv, 4002, Bulgaria
Sofia, 1233, Bulgaria
Sofia, 1233, Bulgaria
Hradec Králové, 500 05, Czechia
Uherské Hradište, 68601, Czechia
Gdynia, 81-157, Poland
Lodz, 94-048, Poland
Arkhangelsk, 163000, Russia
Barnaul, 656055, Russia
Kemerovo, 650002, Russia
Moscow, 121552, Russia
Moscow, 125315, Russia
Moscow, 129090, Russia
Saint Petersburg, 194291, Russia
Saint Petersburg, 197341, Russia
Saint Petersburg, 199106, Russia
Voronezh, 394018, Russia
Yaroslavl, 150047, Russia
Yekaterinburg, 620028, Russia
Ivano-Frankivsk, 76018, Ukraine
Kharkiv, 61002, Ukraine
Kharkiv, 61103, Ukraine
Kharkiv, 61103, Ukraine
Kharkiv, 61103, Ukraine
Kharkiv, 61172, Ukraine
Kyiv, 2002, Ukraine
Kyiv, 4114, Ukraine
Kyiv, 4114, Ukraine
Odesa, 65014, Ukraine