A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12-Week Study With a 40-Week, Active-Controlled, Double-Blind 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 Normal Renal Function
A Phase 3, Multi-Center, Placebo-Controlled, Randomized, Double-Blind, 12-Week Study With a 40-Week, Active-Controlled, Double-Blind 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 Normal Renal Function
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 normal renal function.
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:
Exclusion Criteria:
Dallas, Texas 75216, United States
San Antonio, Texas 78228, United States
Pleven, Bulgaria
Pleven, Bulgaria
Sofia, Bulgaria
Sofia, Bulgaria
Uherské Hradište, Czechia
Gdynia, Poland
Arkhangelsk, Russia
Barnaul, Russia
Kemerovo, Russia
Moscow, Russia
Moscow, Russia
Saint Petersburg, Russia
Saint Petersburg, Russia
Saint Petersburg, Russia
Voronezh, Russia
Yaroslavl, Russia
Yekaterinburg, Russia
Ivano-Frankivsk, Ukraine
Kharkiv, Ukraine
Kharkiv, Ukraine
Kharkiv, Ukraine
Kharkiv, Ukraine
Kharkiv, Ukraine
Kyiv, Ukraine
Kyiv, Ukraine
Kyiv, Ukraine
Odesa, Ukraine