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New pill for high cholesterol shows promise in early trial

NCT ID NCT04079530

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a new controlled-release version of the drug pemafibrate in 60 adults with dyslipidemia (abnormal levels of fats in the blood). The goal was to see if the new version works as well or better than the current immediate-release tablet, with fewer side effects. Participants received different doses of the drug over two periods, and researchers measured changes in triglycerides and cholesterol levels.

What this could mean

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

Active substance
Pemafibrate (a drug to lower blood fats)
What this could lead to
If successful, this could lead to a more convenient, once-daily pill for managing high triglycerides and cholesterol.
What could go wrong
This is an early Phase 2 study with only 60 participants, so results may not apply to everyone. The new controlled-release form might not work better or could have side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

60 people

The number who actually took part.

Started

Sep 2019

Finished

Dec 2019

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(ICF) 2. Men and postmenopausal women. 3. Patients who have received dietary or exercise guidance from 12 weeks prior to Screening. 4. Patients who have clinical laboratory records with fasting serum TG ≥ 150 mg / dL (or ≥ 200 mg / dL if not fasting) within 6 months before written informed consent. 5. Patients with a fasting serum TG ≥ 150 mg / dL at Screening. Exclusion Criteria: 1. Patients with a fasting serum TG ≥ 500 mg / dL at Screening 2. Patients who require administration of prohibited drugs during the clinical trial period after written informed consent 3. Patients who have malabsorption or those who have had the history, or who have undergone other surgical procedures that may affect absorption (excluding appendectomy or hernia treatment etc) 4. Patients with uncontrolled thyroid disease 5. Patients with uncontrolled diabetes as defined by a HbA1c(NGSP) ≥ 8.0% at Screening 6. Persons with uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) 7. Patients with an AST or ALT three times the upper limit at Screening 8. Patients with cirrhosis or those with biliary obstruction 9. Patients with malignant tumor or those who are judged to have a high risk of recurrence 10. 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 11. Patients with a history of serious drug allergies (anaphylactic shock, etc.) 12. Patients with a history of hypersensitivity to pemafibrate, patients who have stopped taking pemafibrate for reasons of insufficient efficacy or safety 13. Patients who participate in other clinical trials at the time of written informed consent or who have received clinical trials other than placebo for less than 16 weeks 14. Patients who have been determined inappropriate by the investigator or subinvestigator

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Medical Corporation Heishinkai OPHAC Hospital

    Osaka, 532-0003, Japan

More trials for these conditions

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