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New Once-Daily pill aims to lower high triglycerides

NCT ID NCT04716595

Disease control Sponsor: Kowa Company, Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new extended-release form of pemafibrate (K-877) in 121 adults with high triglycerides, a type of fat in the blood. Participants took the drug once daily for 52 weeks, either in the morning or evening, to see if it safely lowers triglyceride levels and improves cholesterol. The goal is to offer a convenient treatment option for managing dyslipidemia.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pemafibrate (K-877) extended-release tablet
What this could lead to
If successful, this could provide a once-daily treatment option to lower high triglycerides and improve cholesterol levels, helping manage heart disease risk.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may not work better than existing treatments, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

121 people

The number who actually took part.

Started

Feb 2021

Finished

Jun 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 \>= 150 mg/dL twice consecutively at Screening 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 \[HbA1c(NGSP) \>= 10.0 % at Screening\] 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

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Conditions

The condition(s) this trial relates to.

Dyslipidemias hyperlipidemia inherited lipid metabolism disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dyslipidemias

Contacts and locations

Locations

  • Akasaka Chuou Clinic

    Tokyo, Japan

  • Cosmos medical corporation Aozora total clinic

    Saitama, Japan

  • Hasegawa Medicine Clinic

    Hokkaido, Japan

  • Japan Community Health care Organization Hokkaido Hospital

    Hokkaido, Japan

  • Kinugawa Cardiology Clinic

    Osaka, Japan

  • Kyosokai AMC NISHI-UMEDA Clinic

    Osaka, Japan

  • Medical Corporation Chiseikai Tokyo Center Clinic

    Tokyo, Japan

  • Medical corporation Tani clinic

    Osaka, Japan

  • Minami Akatsuka Clinic

    Ibaraki, Japan

  • National Hospital Organization Takasaki General Medical Center

    Gunma, Japan

  • Saiseikai Futsukaichi Hospital

    Fukuoka, Japan

  • Saiseikai Yokohamashi Nanbu Hospital

    Kanagawa, Japan

  • Shimokitazawa Tomo Clinic

    Tokyo, Japan

  • Shiraiwa medical clinic

    Osaka, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.