At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 551 enrolled
Drug / intervention
K-877 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating K-877, Fenofibrate, and 2 other interventions for Severe Hypertriglyceridemia. Completed, enrolled 551 participants across 220 sites in 9 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Hypertriglyceridemia
CountriesBelarus, Bulgaria, Czechia, Georgia, Hungary, Poland, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartNov 2016
First PostedDec 2016
Primary CompletionJun 2019
TodayJul 2026
First PostedDec 23, 2016
Enrollment StartNov 28, 2016
Primary CompletionJun 24, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.5 years ago
Interventions
K-877drug
Fenofibratedrug
Placebo (for K-877)drug
Placebo (for Fenofibrate)drug