DyslipidemiasPhase 2NCT04079530
A Clinical Pharmacology Study of K-877 Controlled Release Tablet
A Phase 2 study testing K-877 IR 0.2 mg/day, K-877 CR 0.4 mg/day and K-877 CR 0.8 mg/day in people with Dyslipidemias, run by Kowa Company, Ltd. at 1 site in Japan.
Trial summary
A study to compare the efficacy, safety, and pharmacokinetics of K-877 controlled release tablets with a current normal K-877 tablet in dyslipidemia. 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 IR 0.2 mg/day, K-877 CR 0.4 mg/day and K-877 CR 0.8 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- 13 Sep 2019to 24 Dec 2019
- Phase
- Phase 2
- 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(ICF)
- Men and postmenopausal women.
- Patients who have received dietary or exercise guidance from 12 weeks prior to Screening.
- 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.
- Patients with a fasting serum TG ≥ 150 mg / dL at Screening.
Who cannot join
- Patients with a fasting serum TG ≥ 500 mg / dL at Screening
- Patients who require administration of prohibited drugs during the clinical trial period after written informed consent
- 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)
- Patients with uncontrolled thyroid disease
- Patients with uncontrolled diabetes as defined by a HbA1c(NGSP) ≥ 8.0％ at Screening
- Persons with uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg)
Show all 14Show fewer
- Patients with an AST or ALT three times the upper limit at Screening
- Patients with cirrhosis or those with biliary obstruction
- Patients with malignant tumor or those who are judged to have a high risk of recurrence
- 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 with a history of serious drug allergies (anaphylactic shock, etc.)
- Patients with a history of hypersensitivity to pemafibrate, patients who have stopped taking pemafibrate for reasons of insufficient efficacy or safety
- 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
- Patients who have been determined inappropriate by the investigator or subinvestigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Active-controlled, Single-blind, 2-Period, 12-Sequence Crossover Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Pemafibrate in Patients With Dyslipidemia
A study to compare the efficacy, safety, and pharmacokinetics of K-877 controlled release tablets with a current normal K-877 tablet in dyslipidemia.
- Conditions
- Dyslipidemias
- Being tested
- K-877 IR 0.2 mg/day, K-877 CR 0.4 mg/day, K-877 CR 0.8 mg/day
- 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 IR 0.2 mg/dayDrug
Also called Pemafibrate
K-877 IR 0.1 mg tablet
K-877 CR 0.4 mg/dayDrug
Also called Pemafibrate
K-877 CR 0.4 mg tablet
K-877 CR 0.8 mg/dayDrug
Also called Pemafibrate
Two K-877 CR 0.4 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal) Receives: Drug: K-877 IR 0.2 mg/day; Drug: K-877 CR 0.4 mg/day |
| Treatment B | Experimental | Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial) Receives: Drug: K-877 IR 0.2 mg/day; Drug: K-877 CR 0.4 mg/day |
| Treatment C | Experimental | Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal) Receives: Drug: K-877 IR 0.2 mg/day; Drug: K-877 CR 0.8 mg/day |
| Treatment D | Experimental | Period1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial) Receives: Drug: K-877 IR 0.2 mg/day; Drug: K-877 CR 0.8 mg/day |
| Treatment E | Experimental | Period1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal) Receives: Drug: K-877 IR 0.2 mg/day; Drug: K-877 CR 0.4 mg/day |
| Treatment F | Experimental | Period1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial) Receives: Drug: K-877 IR 0.2 mg/day; Drug: K-877 CR 0.4 mg/day |
| Treatment G | Experimental | Period1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal) Receives: Drug: K-877 CR 0.4 mg/day; Drug: K-877 CR 0.8 mg/day |
| Treatment H | Experimental | Period1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial) Receives: Drug: K-877 CR 0.4 mg/day; Drug: K-877 CR 0.8 mg/day |
| Treatment I | Experimental | Period1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal) Receives: Drug: K-877 IR 0.2 mg/day; Drug: K-877 CR 0.8 mg/day |
| Treatment J | Experimental | Period1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial) Receives: Drug: K-877 IR 0.2 mg/day; Drug: K-877 CR 0.8 mg/day |
| Treatment K | Experimental | Period1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal) Receives: Drug: K-877 CR 0.4 mg/day; Drug: K-877 CR 0.8 mg/day |
| Treatment L | Experimental | Period1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial) Receives: Drug: K-877 CR 0.4 mg/day; Drug: K-877 CR 0.8 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: % change from baseline in fasting serum TG(mg/dL)
Measured: 4 week after administration in each period
Secondary outcomes (4)
% change from baseline in fasting HDL-C levels(mg/dL)
Measured: 4 week after administration in each period
% change from baseline in fasting LDL-C levels(mg/dL)
Measured: 4 week after administration in each period
% change from baseline in fasting non-HDL-C levels(mg/dL)
Measured: 4 week after administration in each period
% change from baseline in fasting Total Cholesterol levels(mg/dL)
Measured: 4 week after administration in each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start13 Sep 2019
- Primary completion24 Dec 2019
- Study completion24 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kowa Company, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079530
- Sponsor's protocol ID
- K-877-CR-01
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2019
- Last updated
- 6 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yamashita S, Araki E, Arai H, Yokote K, Tanigawa R, Saito A, Suganami H, Minamikawa S, Ishibashi S. Clinical Pharmacology of Pemafibrate Extended-release Formulation in Patients with Hypertriglyceridemia-A Phase 2, Multicenter, Active-controlled, Randomized, Single-blind, Crossover study. J Atheroscler Thromb. 2025 Mar 1;32(3):367-384. doi: 10.5551/jat.65001. Epub 2024 Sep 26.
PubMed 39322570
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Active-controlled, Single-blind, 2-Period, 12-Sequence Crossover Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Pemafibrate in Patients With Dyslipidemia
- ClinicalTrials.gov ID
- NCT04079530
- Acronym / sponsor ID
- K-877-CR-01
- Conditions
- Dyslipidemias
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kowa Company, Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 24 Dec 2019 (actual)
- Study completion
- 24 Dec 2019 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to compare the efficacy, safety, and pharmacokinetics of K-877 controlled release tablets with a current normal K-877 tablet in dyslipidemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: K-877 IR 0.2 mg/day, Drug: K-877 CR 0.4 mg/dayPeriod1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal) |
| Treatment B | Experimental | Drug: K-877 IR 0.2 mg/day, Drug: K-877 CR 0.4 mg/dayPeriod1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial) |
| Treatment C | Experimental | Drug: K-877 IR 0.2 mg/day, Drug: K-877 CR 0.8 mg/dayPeriod1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal) |
| Treatment D | Experimental | Drug: K-877 IR 0.2 mg/day, Drug: K-877 CR 0.8 mg/dayPeriod1:K-877 IR 0.2 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial) |
| Treatment E | Experimental | Drug: K-877 IR 0.2 mg/day, Drug: K-877 CR 0.4 mg/dayPeriod1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal) |
| Treatment F | Experimental | Drug: K-877 IR 0.2 mg/day, Drug: K-877 CR 0.4 mg/dayPeriod1:K-877 CR 0.4 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial) |
| Treatment G | Experimental | Drug: K-877 CR 0.4 mg/day, Drug: K-877 CR 0.8 mg/dayPeriod1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (pre-meal) |
| Treatment H | Experimental | Drug: K-877 CR 0.4 mg/day, Drug: K-877 CR 0.8 mg/dayPeriod1:K-877 CR 0.4 mg/day, Period2:K-877 CR 0.8 mg/day (postprandial) |
| Treatment I | Experimental | Drug: K-877 IR 0.2 mg/day, Drug: K-877 CR 0.8 mg/dayPeriod1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (pre-meal) |
| Treatment J | Experimental | Drug: K-877 IR 0.2 mg/day, Drug: K-877 CR 0.8 mg/dayPeriod1:K-877 CR 0.8 mg/day, Period2:K-877 IR 0.2 mg/day (postprandial) |
| Treatment K | Experimental | Drug: K-877 CR 0.4 mg/day, Drug: K-877 CR 0.8 mg/dayPeriod1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (pre-meal) |
| Treatment L | Experimental | Drug: K-877 CR 0.4 mg/day, Drug: K-877 CR 0.8 mg/dayPeriod1:K-877 CR 0.8 mg/day, Period2:K-877 CR 0.4 mg/day (postprandial) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with dyslipidemia had to be age 20 years or older at written informed consent(ICF)
- Men and postmenopausal women.
- Patients who have received dietary or exercise guidance from 12 weeks prior to Screening.
- 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.
- Patients with a fasting serum TG ≥ 150 mg / dL at Screening.
Key exclusion criteria (14 listed)
- Patients with a fasting serum TG ≥ 500 mg / dL at Screening
- Patients who require administration of prohibited drugs during the clinical trial period after written informed consent
- 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)
- Patients with uncontrolled thyroid disease
- Patients with uncontrolled diabetes as defined by a HbA1c(NGSP) ≥ 8.0％ at Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| K-877 IR 0.2 mg/dayAlso: PemafibrateK-877 IR 0.1 mg tablet | Drug | Treatment A, Treatment B, Treatment C, Treatment D, Treatment E, Treatment F, Treatment I, Treatment J |
| K-877 CR 0.4 mg/dayAlso: PemafibrateK-877 CR 0.4 mg tablet | Drug | Treatment A, Treatment B, Treatment E, Treatment F, Treatment G, Treatment H, Treatment K, Treatment L |
| K-877 CR 0.8 mg/dayAlso: PemafibrateTwo K-877 CR 0.4 mg tablet | Drug | Treatment C, Treatment D, Treatment G, Treatment H, Treatment I, Treatment J, Treatment K, Treatment L |
Primary outcome
Efficacy: % change from baseline in fasting serum TG(mg/dL)
Time frame: 4 week after administration in each period
4 secondary outcomes
% change from baseline in fasting HDL-C levels(mg/dL)
Time frame: 4 week after administration in each period
% change from baseline in fasting LDL-C levels(mg/dL)
Time frame: 4 week after administration in each period
% change from baseline in fasting non-HDL-C levels(mg/dL)
Time frame: 4 week after administration in each period
% change from baseline in fasting Total Cholesterol levels(mg/dL)
Time frame: 4 week after administration in each period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Results publication: PubMed 39322570Yamashita S, Araki E, Arai H, Yokote K, Tanigawa R, Saito A, Suganami H, Minamikawa S, Ishibashi S. Clinical Pharmacology of Pemafibrate Extended-release Formulation in Patients with Hypertriglyceridemia-A Phase 2, Multicenter, Active-controlled, Randomized, Single-blind, Crossover study. J Atheroscler Thromb. 2025 Mar 1;32(3):367-384. doi: 10.5551/jat.65001. Epub 2024 Sep 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing K-877 IR 0.2 mg/day, K-877 CR 0.4 mg/day and K-877 CR 0.8 mg/day in people with Dyslipidemias, run by Kowa Company, Ltd. at 1 site 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 5 inclusion and 14 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 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: % change from baseline in fasting serum TG(mg/dL) (time frame: 4 week after administration in each period). 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 NCT04079530, which also lists 1 linked publication.
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 6 Oct 2025.