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DyslipidemiasPhase 3NCT04714151

A Phase III Confirmatory Study of K-877 Extended Release Tablet

A Phase 3 study testing K-877 ER 0.2 mg/day (once daily), K-877 ER 0.4 mg/day (once daily) and K-877 IR 0.2 mg/day (twice daily) in people with Dyslipidemias, run by Kowa Company, Ltd. at 11 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 efficacy and safety of K-877 Extended Release (ER) 0.2 mg/day or 0.4 mg/day (once daily) for 12 weeks in dyslipidemia, using K-877 Immediate Release (IR) 0.2 mg/day (twice daily) as a control. 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 (once daily), K-877 ER 0.4 mg/day (once daily) and K-877 IR 0.2 mg/day (twice daily)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
356 participants
Where
11 sitesJapan
Study dates
1 Feb 2021to 25 Sep 2021
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 >= 200 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) >= 8.0 % 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

11 sites in 1 country.

11 sites in 1 country

Japan11 sites

  • Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic

    Kanagawa

  • Medical Corporation Heishinkai OCROM Clinic

    Osaka

  • Dojinkinenkai Meiwa Hospital

    Tokyo

  • Fukuwa Clinic

    Tokyo

  • Ikebukuro Metropolitan Clinic

    Tokyo

  • Medical Corp. Seikoukai New Medical Research System Clinic

    Tokyo

  • Medical Corporation Asbo Tokyo Asbo Clinic

    Tokyo

  • Medical Corporation Chiseikai Tokyo Center Clinic

    Tokyo

  • Medical Corporation Heishinkai ToCROM Clinic

    Tokyo

  • Medical Corporation Yuhokai Miho Clinic

    Tokyo

  • Tokyo-Eki Center-building Clinic

    Tokyo

Other trials in Japan

About this study

Official title: A Phase III Confirmatory Study of K-877 Extended Release Tablet-A Multicenter, Active Controlled, Randomized, Double Blind, Parallel Group Controlled Trial in Patients With Dyslipidemia With High TG-

To investigate the efficacy and safety of K-877 Extended Release (ER) 0.2 mg/day or 0.4 mg/day (once daily) for 12 weeks in dyslipidemia, using K-877 Immediate Release (IR) 0.2 mg/day (twice daily) as a control.

Conditions
Dyslipidemias
Being tested
K-877 ER 0.2 mg/day (once daily), K-877 ER 0.4 mg/day (once daily), K-877 IR 0.2 mg/day (twice 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 (once daily)Drug

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

    K-877 ER 0.2 mg tablet

  • K-877 ER 0.4 mg/day (once daily)Drug

    Also called Pemafibrate ER 0.4 mg/day (once daily)

    K-877 ER 0.4 mg tablet

  • K-877 IR 0.2 mg/day (twice daily)Drug

    Also called Pemafibrate IR 0.2 mg/day (twice daily)

    K-877 IR 0.1 mg tablet

Study groups in NCT04714151
Study groupRoleWhat they receive
Treatment AExperimentalK-877 ER 0.2 mg/day (once daily)
Receives: Drug: K-877 ER 0.2 mg/day (once daily)
Treatment BExperimentalK-877 ER 0.4 mg/day (once daily)
Receives: Drug: K-877 ER 0.4 mg/day (once daily)
Control AActive comparatorK-877 IR 0.2 mg/day (twice daily)
Receives: Drug: K-877 IR 0.2 mg/day (twice daily)

What is being measured

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

  1. Efficacy : % change from baseline in fasting serum TG (mg/dL)

    Measured: 4, 8, and 12 week after administration

Secondary outcomes (4)

  1. Efficacy : % change from baseline in fasting serum Total Cholesterol (mg/dL)

    Measured: 4, 8, and 12 week after administration

  2. Efficacy : % change from baseline in fasting serum LDL-C (mg/dL)

    Measured: 4, 8, and 12 week after administration

  3. Efficacy : % change from baseline in fasting serum HDL-C (mg/dL)

    Measured: 4, 8, and 12 week after administration

  4. Efficacy : % change from baseline in fasting serum non-HDL-C (mg/dL)

    Measured: 4, 8, and 12 week after administration

Timeline

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

  1. First posted19 Jan 2021
  2. Study start1 Feb 2021
  3. Primary completion25 Sep 2021
  4. Study completion25 Sep 2021

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
356 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04714151
Sponsor's protocol ID
K-877-ER-02
Status last verified
Jun 2024
First submitted
15 Jan 2021
Last updated
20 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Arai H, Yamashita S, Araki E, Yokote K, Tanigawa R, Saito A, Yamasaki S, Suganami H, Ishibashi S. Efficacy and Safety of Pemafibrate Extended-Release Tablet: a Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group Comparison Trial. J Atheroscler Thromb. 2024 Nov 1;31(11):1517-1538. doi: 10.5551/jat.64677. Epub 2024 Apr 13.

    PubMed 38616112

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing K-877 ER 0.2 mg/day (once daily), K-877 ER 0.4 mg/day (once daily) and K-877 IR 0.2 mg/day (twice daily) in people with Dyslipidemias, run by Kowa Company, Ltd. at 11 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 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 : % change from baseline in fasting serum TG (mg/dL) (time frame: 4, 8, and 12 week after administration). 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 NCT04714151, 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 20 Jun 2024.

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