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Completed

NCT Number: NCT04716595

A Phase III Long Term Study of K-877 Extended Release Tablet

To investigate the safety and efficacy of K-877 Extended Release (ER) once daily for 52 weeks in the morning or evening in dyslipidema.The starting dose of the ER tablet will be 0.2 mg/day. If the efficacy is insufficient, it will investigate the safety and efficacy of 0.4 mg/day.

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Key information

Conditions

Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Saiseikai Futsukaichi Hospital, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with dyslipidemia had to be age 20 years or older at written informed consent
  • Patients who have received dietary or exercise guidance from 12 weeks or more prior to Screening
  • Patients with the fasting serum TG >= 150 mg/dL twice consecutively at Screening

Exclusion criteria

  • Patients with a fasting serum TG > 1000 mg/dL at Screening
  • Patients who require administration of prohibited drugs during the clinical trial period after written informed consent
  • Patients with uncontrolled thyroid disease
  • Patients with type 1 diabetes and uncontrolled diabetes [HbA1c(NGSP) >= 10.0 % at Screening]
  • Patients with uncontrolled hypertension (SBP >= 160 mmHg or DBP >= 100 mmHg)
  • Patients with an AST or ALT three times the upper limit at Screening
  • Patients with an CK five times the upper limit at Screening
  • Patients with cirrhosis or those with biliary obstruction
  • Patients with acute myocardial infarction within 3 months before obtaining informed consent
  • Patients with heart failure class III or higher according to NYHA cardiac function classification
  • Patients with malignant tumor or those who are judged to have a high risk of recurrence
  • Patients with a history of serious drug allergies (anaphylactic shock, etc.)
  • Pregnant women, lactating women, women planning to become pregnant or lactating during the study period, or pregnant women who do not use specific contraceptive methods
  • Patients who have collected 400 mL or more of whole blood within 16 weeks, or 200 mL or more of whole blood within 4 weeks, or blood samples (plasma and platelet components) within 2 weeks before Screening
  • Patients who have received K-877 (pemafibrate)
  • Patients who participate in other clinical trials at the time of written informed consent and who received medication or who have received clinical trials other than placebo for less than 16 weeks
  • Patients who have been determined inappropriate by the investigator, etc

Treatment and study plan

K-877 ER 0.2 mg/day morning administration (once daily)

Drug

K-877 ER 0.2 mg tablet

Other names: Pemafibrate ER 0.2 mg/day morning administration (once daily)

K-877 ER 0.2 mg/day evening administration (once daily)

Drug

K-877 ER 0.2 mg tablet

Other names: Pemafibrate ER 0.2 mg/day evening administration (once daily)

Primary outcomes

  1. Efficacy : Mean of percent change from baseline in fasting serum TG (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation

    Time frame: Final evaluation (Week 52 or at discontinuation) and immediately before it

Secondary outcomes

  1. Efficacy : Mean of percent change from baseline in fasting serum Total Cholesterol (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation

    Time frame: Final evaluation (Week 52 or at discontinuation) and immediately before it

  2. Efficacy : Mean of percent change from baseline in fasting serum LDL-C (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation

    Time frame: Final evaluation (Week 52 or at discontinuation) and immediately before it

  3. Efficacy : Mean of percent change from baseline in fasting serum HDL-C (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation

    Time frame: Final evaluation (Week 52 or at discontinuation) and immediately before it

  4. Efficacy : Mean of percent change from baseline in fasting serum non-HDL-C (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation

    Time frame: Final evaluation (Week 52 or at discontinuation) and immediately before it

Sponsors and collaborators

Lead sponsor

Kowa Company, Ltd.

Industry

Registry information

Official study title

A Phase III Long Term Study of K-877 Extended Release Tablet-A Multicenter, Randomized, Open Label, Parallel Group Trial in Patients With Dyslipidemia With High TG-

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2021
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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