ClinicalTrials.gg
Sign In
CompletedNCT04714151Updated Jun 20, 2024

A Phase III Confirmatory Study of K-877 Extended Release Tablet

A Phase 3 interventional study of K-877 ER 0.2 mg/day (once daily) and K-877 ER 0.4 mg/day (once daily) in Dyslipidemias, sponsored by Kowa Company, Ltd.. Completed at 11 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-06-20.

Sponsored by Kowa Company, Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
356
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

To investigate the efficacy and safety of K-877 Extended Release (ER) 0.2 mg/day or 0.4 mg/day (once daily) for 12 weeks in dyslipidemia, using K-877 Immediate Release (IR) 0.2 mg/day (twice daily) as a control.

02

Conditions studied

  • Dyslipidemias

Browse trials for

03

In context

Dyslipidemias

1,101 studies on the registry are indexed under Dyslipidemias; 161 are open to participants now.

This study's enrollment of 356 is above the median of 100 across 861 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Kowa Company, Ltd. is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Browse Kowa Company, Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients with dyslipidemia had to be age 20 years or older at written informed consent
  2. Patients who have received dietary or exercise guidance from 12 weeks or more prior to Screening
  3. Patients with the fasting serum TG >= 200 mg/dL twice consecutively at Screening

Exclusion criteria

Exclusion Criteria:

  1. Patients with a fasting serum TG > 1000 mg/dL at Screening
  2. Patients who require administration of prohibited drugs during the clinical trial period after written informed consent
  3. Patients with uncontrolled thyroid disease
  4. Patients with type 1 diabetes and uncontrolled diabetes [HbA1c(NGSP) >= 8.0 % at Screening]
  5. Patients with uncontrolled hypertension (SBP >= 160 mmHg or DBP >= 100 mmHg)
  6. Patients with an AST or ALT three times the upper limit at Screening
  7. Patients with an CK five times the upper limit at Screening
  8. Patients with cirrhosis or those with biliary obstruction
  9. Patients with acute myocardial infarction within 3 months before obtaining informed consent
  10. Patients with heart failure class III or higher according to NYHA cardiac function classification
  11. Patients with malignant tumor or those who are judged to have a high risk of recurrence
  12. Patients with a history of serious drug allergies (anaphylactic shock, etc.)
  13. 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
  14. 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
  15. Patients who have received K-877 (pemafibrate)
  16. 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
  17. Patients who have been determined inappropriate by the investigator, etc
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
356 participants (actual)

Study arms

  • Experimental
    Treatment A

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

    Drug: K-877 ER 0.2 mg/day (once daily)

  • Experimental
    Treatment B

    K-877 ER 0.4 mg/day (once daily)

    Drug: K-877 ER 0.4 mg/day (once daily)

  • Active comparator
    Control A

    K-877 IR 0.2 mg/day (twice daily)

    Drug: K-877 IR 0.2 mg/day (twice daily)

Interventions

  • DrugK-877 ER 0.2 mg/day (once daily)

    K-877 ER 0.2 mg tablet

    Also known as: Pemafibrate ER 0.2 mg/day (once daily)

  • DrugK-877 ER 0.4 mg/day (once daily)

    K-877 ER 0.4 mg tablet

    Also known as: Pemafibrate ER 0.4 mg/day (once daily)

  • DrugK-877 IR 0.2 mg/day (twice daily)

    K-877 IR 0.1 mg tablet

    Also known as: Pemafibrate IR 0.2 mg/day (twice daily)

06

What researchers measure

Primary outcomes

  1. Efficacy : % change from baseline in fasting serum TG (mg/dL)

    Time frame: 4, 8, and 12 week after administration

Secondary outcomes

  1. Efficacy : % change from baseline in fasting serum Total Cholesterol (mg/dL)

    Time frame: 4, 8, and 12 week after administration

  2. Efficacy : % change from baseline in fasting serum LDL-C (mg/dL)

    Time frame: 4, 8, and 12 week after administration

  3. Efficacy : % change from baseline in fasting serum HDL-C (mg/dL)

    Time frame: 4, 8, and 12 week after administration

  4. Efficacy : % change from baseline in fasting serum non-HDL-C (mg/dL)

    Time frame: 4, 8, and 12 week after administration

07

Study locations

11 sites
  • Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
    Kanagawa, Japan
  • Medical Corporation Heishinkai OCROM Clinic
    Osaka, Japan
  • Dojinkinenkai Meiwa Hospital
    Tokyo, Japan
  • Fukuwa Clinic
    Tokyo, Japan
  • Ikebukuro Metropolitan Clinic
    Tokyo, Japan
  • Medical Corp. Seikoukai New Medical Research System Clinic
    Tokyo, Japan
  • Medical Corporation Asbo Tokyo Asbo Clinic
    Tokyo, Japan
  • Medical Corporation Chiseikai Tokyo Center Clinic
    Tokyo, Japan
  • Medical Corporation Heishinkai ToCROM Clinic
    Tokyo, Japan
  • Medical Corporation Yuhokai Miho Clinic
    Tokyo, Japan
  • Tokyo-Eki Center-building Clinic
    Tokyo, Japan
08

References and documents

Publications

  • Arai H, Yamashita S, Araki E, Yokote K, Tanigawa R, Saito A, Yamasaki S, Suganami H, Ishibashi S. Efficacy and Safety of Pemafibrate Extended-Release Tablet: a Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group Comparison Trial. J Atheroscler Thromb. 2024 Nov 1;31(11):1517-1538. doi: 10.5551/jat.64677. Epub 2024 Apr 13. PubMed 38616112 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04714151
Lead sponsor
Kowa Company, Ltd.
Responsible party
Sponsor
First posted
Jan 19, 2021
Start date
Feb 1, 2021
Primary completion
Sep 25, 2021
Completion
Sep 25, 2021
Last update
Jun 20, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Dyslipidemias →

Other studies from this sponsor

Kowa Company, Ltd. →

Start the discussion