New pill for high cholesterol shows promise in early trial
NCT ID NCT04079530
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 Hide 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
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