Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels 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
Sponsor: Kowa Research Institute, Inc.
Listed as NCT03011450, this PHASE3 trial focuses on Severe Hypertriglyceridemia and remains completed. Sponsored by Kowa Research Institute, Inc., it has been updated 13 times since 2016, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
13 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
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Nov 2022 — Jul 2024 [monthly]
Completed PHASE3
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Apr 2022 — Nov 2022 [monthly]
Completed PHASE3
▶ Show 8 earlier versions
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Jan 2021 — Apr 2022 [monthly]
Completed PHASE3
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Jun 2020 — Jan 2021 [monthly]
Completed PHASE3
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Nov 2019 — Jun 2020 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
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Jan 2019 — Nov 2019 [monthly]
Active Not Recruiting PHASE3
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Aug 2018 — Jan 2019 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
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Jun 2018 — Aug 2018 [monthly]
Recruiting PHASE3
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Oct 2017 — Jun 2018 [monthly]
Recruiting PHASE3
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Feb 2017 — Oct 2017 [monthly]
Recruiting PHASE3
First recorded
Nov 2016
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Kowa Research Institute, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .