CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 471 enrolled
Drug / intervention
K-877 +2 moredrug
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Age ≥18 years
  • ✓Fasting triglycerides 500-1999 mg/dL (mean of Week -2 and Week -1 visits)
  • ✓Mild to moderate renal impairment with eGFR ≥30 and <90 mL/min/1.73
  • ✓On statin therapy (moderate- or high-intensity) with documented cardiovascular or metabolic criteria, or on low-intensity/no statin with specific justifications
Key exclusion· 4
  • ✕Use of lipid-altering treatments other than K-877, fenofibrate, statins, ezetimibe, or PCSK9 inhibitors (including bile acid sequestrants, other fibrates, niacin >100 mg/day, omega-3 >1000 mg/day, red rice yeast, garlic, soy isoflavone supplements, sterol/stanol products, or policosanols)
  • ✕BMI >45 kg/m²
  • ✕Type 1 diabetes mellitus
  • ✕Type 2 diabetes newly diagnosed within 3 months or poorly controlled (HbA1c >9.5%)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03011450
NCT03011450Phase 3Completed
CompareCT.gov

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

Kowa Research Institute, Inc.·interventional·Posted Jan 5, 2017·Updated Oct 28, 2022

In Brief

A Phase 3 clinical trial evaluating K-877, Fenofibrate, and 1 other intervention for Severe Hypertriglyceridemia. Completed, enrolled 471 participants across 241 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 Mild or Moderate Renal Impairment.

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
First PostedJan 5, 2017
Enrollment StartNov 26, 2016
Primary CompletionJul 5, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.5 years ago

Interventions

K-877drug

Fenofibratedrug

Placebo (for K-877)drug