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COMPLETED Phase 3

Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function

NCT03001817 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Fenofibrate
  • DRUG K-877
  • DRUG Placebo (for K-877)
  • DRUG Placebo (for Fenofibrate)

Study Locations (20)

Alabama

  • Central Research Associates, Inc. — Birmingham
  • Central Alabama Research — Birmingham
  • Cahaba Research, Inc. — Birmingham
  • Boyett Health Services Inc — Hamilton
  • Longwood Research - Saadat Ansari, MD, LLC — Huntsville
  • Terence T. Hart, MD — Tuscumbia

California

  • Advanced Research Center — Anaheim
  • Torrance Clinical Research Institute Inc. — Lomita
  • Downtown L.A. Research Center, Inc. — Los Angeles
  • Catalina Research Institute, LLC — Montclair
  • Lucita M. Cruz, MD., Inc. — Norwalk

Arizona

  • Arrowhead Health Centers — Glendale
  • Phoenix Medical Research Institute, LLC — Peoria
  • Elite Clinical Studies — Phoenix
  • Clinical Research Institute of Arizona, LLC — Surprise

Arkansas

  • iResearch - Little Rock — Little Rock
  • Lynn Institute of the Ozarks — Little Rock

Florida

  • Atlantic Clinical Research Collaborative — Boynton Beach
  • ALL Medical Research, LLC — Cooper City

Colorado

  • Creekside Endocrine Associates, PC — Denver

Trial Details

FieldValue
Enrollment Target 551 participants
Start Date 2016-11-28
Est. Completion 2019-06-24
Phase Phase 3

Sponsor

Kowa Research Institute

9 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03001817

The ClinicalTrials.gov registry entry for NCT03001817 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 551 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kowa Research Institute, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Severe Hypertriglyceridemia appearing as the primary indexed condition, and to 4 interventions — of which Fenofibrate is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03001817 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Alabama, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03001817 about?

NCT03001817 is a clinical study titled "Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels 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.

What is the current status of trial NCT03001817?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 551 participants. The study started on 2016-11-28. Estimated completion is 2019-06-24.

What conditions does trial NCT03001817 study?

This clinical trial studies the following conditions: Severe Hypertriglyceridemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03001817?

The interventions under investigation include: Fenofibrate (DRUG), K-877 (DRUG), Placebo (for K-877) (DRUG), Placebo (for Fenofibrate) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03001817?

This trial is sponsored by Kowa Research Institute, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03001817 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial