A Phase III Long Term Study of K-877 Extended Release Tablet

NCT ID: NCT04716595

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-06-13

Brief Summary

To investigate the safety and efficacy of K-877 Extended Release (ER) once daily for 52 weeks in the morning or evening in dyslipidema.The starting dose of the ER tablet will be 0.2 mg/day. If the efficacy is insufficient, it will investigate the safety and efficacy of 0.4 mg/day.

Conditions

Dyslipidemias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

morning administration

K-877 ER 0.2 mg/day morning administration (once daily)

Group Type: EXPERIMENTAL

K-877 ER 0.2 mg/day morning administration (once daily)

Intervention Type: DRUG

K-877 ER 0.2 mg tablet

evening administration

K-877 ER 0.2 mg/day evening administration (once daily)

Group Type: EXPERIMENTAL

K-877 ER 0.2 mg/day evening administration (once daily)

Intervention Type: DRUG

K-877 ER 0.2 mg tablet

Interventions

K-877 ER 0.2 mg/day morning administration (once daily)

K-877 ER 0.2 mg tablet

Intervention Type: DRUG

K-877 ER 0.2 mg/day evening administration (once daily)

K-877 ER 0.2 mg tablet

Intervention Type: DRUG

Other Intervention Names

Pemafibrate ER 0.2 mg/day morning administration (once daily); Pemafibrate ER 0.2 mg/day evening administration (once daily)

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kowa Company, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Saiseikai Futsukaichi Hospital

Fukuoka, , Japan

National Hospital Organization Takasaki General Medical Center

Gunma, , Japan

Hasegawa Medicine Clinic

Hokkaido, , Japan

Japan Community Health care Organization Hokkaido Hospital

Hokkaido, , Japan

Minami Akatsuka Clinic

Ibaraki, , Japan

Saiseikai Yokohamashi Nanbu Hospital

Kanagawa, , Japan

Kinugawa Cardiology Clinic

Osaka, , Japan

Kyosokai AMC NISHI-UMEDA Clinic

Osaka, , Japan

Medical corporation Tani clinic

Osaka, , Japan

Shiraiwa medical clinic

Osaka, , Japan

Cosmos medical corporation Aozora total clinic

Saitama, , Japan

Akasaka Chuou Clinic

Tokyo, , Japan

Medical Corporation Chiseikai Tokyo Center Clinic

Tokyo, , Japan

Shimokitazawa Tomo Clinic

Tokyo, , Japan

Countries

Japan

References

Arai H, Yamashita S, Araki E, Yokote K, Tanigawa R, Saito A, Furukawa D, Suganami H, Ishibashi S. Long-Term Effects of Extended-Release Pemafibrate Tablets on Dyslipidemia and Safety in Triglyceridemic Patients: A Phase 3, Multicenter, Randomized, Open-Label, Parallel-Group Study. J Atheroscler Thromb. 2025 Aug 1;32(8):1006-1026. doi: 10.5551/jat.65350. Epub 2025 Feb 7.

Reference Type: RESULT

PMID: 39924184 (View on PubMed)

Other Identifiers

K-877-ER-03

Identifier Type: -

Identifier Source: org_study_id