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DyslipidemiasPhase 3NCT04716595

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

A Phase 3 study testing K-877 ER 0.2 mg/day morning administration (once daily) and K-877 ER 0.2 mg/day evening administration (once daily) in people with Dyslipidemias, run by Kowa Company, Ltd. at 14 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Dyslipidemias
What is being tested?
K-877 ER 0.2 mg/day morning administration (once daily) and K-877 ER 0.2 mg/day evening administration (once daily)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
14 sitesJapan
Study dates
1 Feb 2021to 13 Jun 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Japan14 sites

  • Saiseikai Futsukaichi Hospital

    Fukuoka

  • National Hospital Organization Takasaki General Medical Center

    Gunma

  • Hasegawa Medicine Clinic

    Hokkaido

  • Japan Community Health care Organization Hokkaido Hospital

    Hokkaido

  • Minami Akatsuka Clinic

    Ibaraki

  • Saiseikai Yokohamashi Nanbu Hospital

    Kanagawa

  • Kinugawa Cardiology Clinic

    Osaka

  • Kyosokai AMC NISHI-UMEDA Clinic

    Osaka

  • Medical corporation Tani clinic

    Osaka

  • Shiraiwa medical clinic

    Osaka

  • Cosmos medical corporation Aozora total clinic

    Saitama

  • Akasaka Chuou Clinic

    Tokyo

  • Medical Corporation Chiseikai Tokyo Center Clinic

    Tokyo

  • Shimokitazawa Tomo Clinic

    Tokyo

Other trials in Japan

About this study

Official 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-

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.

Conditions
Dyslipidemias
Being tested
K-877 ER 0.2 mg/day morning administration (once daily), K-877 ER 0.2 mg/day evening administration (once daily)
Medical subject headings
Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Pemafibrate ER 0.2 mg/day morning administration (once daily)

    K-877 ER 0.2 mg tablet

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

    Also called Pemafibrate ER 0.2 mg/day evening administration (once daily)

    K-877 ER 0.2 mg tablet

Study groups in NCT04716595
Study groupRoleWhat they receive
morning administrationExperimentalK-877 ER 0.2 mg/day morning administration (once daily)
Receives: Drug: K-877 ER 0.2 mg/day morning administration (once daily)
evening administrationExperimentalK-877 ER 0.2 mg/day evening administration (once daily)
Receives: Drug: K-877 ER 0.2 mg/day evening administration (once daily)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (4)

  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

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2021
  2. Study start1 Feb 2021
  3. Primary completion13 Jun 2022
  4. Study completion13 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04716595
Sponsor's protocol ID
K-877-ER-03
Status last verified
Nov 2025
First submitted
15 Jan 2021
Last updated
24 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Arai H, Yamashita S, Araki E, Yokote K, Tanigawa R, Saito A, Furukawa D, Suganami H, Ishibashi S. Long-Term Effects of Extended-Release Pemafibrate Tablets on Dyslipidemia and Safety in Triglyceridemic Patients: A Phase 3, Multicenter, Randomized, Open-Label, Parallel-Group Study. J Atheroscler Thromb. 2025 Aug 1;32(8):1006-1026. doi: 10.5551/jat.65350. Epub 2025 Feb 7.

    PubMed 39924184

  • Tanigawa R, Ueno Y, Takahashi H, Saito A, Suganami H, Tanaka A. Pemafibrate Improves Cholestatic Markers Regardless of the Presence of Primary Biliary Cholangitis. Hepatol Res. 2026 Jul 15. doi: 10.1111/hepr.70244. Online ahead of print.

    PubMed 42458967

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing K-877 ER 0.2 mg/day morning administration (once daily) and K-877 ER 0.2 mg/day evening administration (once daily) in people with Dyslipidemias, run by Kowa Company, Ltd. at 14 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04716595, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.

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