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

• ClinicalTrials.gov Identifier: NCT04716595
• Recruitment Status: Active, not recruiting
• First Posted: January 20, 2021
• Last Update Posted: June 18, 2021
• Sponsor: Kowa Company, Ltd.
• Information provided by (Responsible Party): Kowa Company, Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dyslipidemias	Drug: K-877 ER 0.2 mg/day morning administration (once daily); Drug: K-877 ER 0.2 mg/day evening administration (once daily)	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III Long Term Study of K-877 Extended Release Tablet-A Multicenter, Randomized, Open Label, Parallel Group Trial in Patients With Dyslipidemia With High TG-
• Actual Study Start Date: February 1, 2021
• Estimated Primary Completion Date: September 30, 2022
• Estimated Study Completion Date: September 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: morning administration; K-877 ER 0.2 mg/day morning administration (once daily)	Drug: K-877 ER 0.2 mg/day morning administration (once daily); K-877 ER 0.2 mg tablet; Other Name: Pemafibrate ER 0.2 mg/day morning administration (once daily)
Experimental: evening administration; K-877 ER 0.2 mg/day evening administration (once daily)	Drug: K-877 ER 0.2 mg/day evening administration (once daily); K-877 ER 0.2 mg tablet; Other Name: Pemafibrate ER 0.2 mg/day evening administration (once daily)

Outcome Measures

Primary Outcome Measures :

1. Efficacy : Mean of percent change from baseline in fasting serum TG (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation [ Time Frame: Final evaluation (Week 52 or at discontinuation) and immediately before it ]

Secondary Outcome Measures :

1. Efficacy : Mean of percent change from baseline in fasting serum Total Cholesterol (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation [ Time Frame: Final evaluation (Week 52 or at discontinuation) and immediately before it ]
2. Efficacy : Mean of percent change from baseline in fasting serum LDL-C (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation [ Time Frame: Final evaluation (Week 52 or at discontinuation) and immediately before it ]
3. Efficacy : Mean of percent change from baseline in fasting serum HDL-C (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation [ Time Frame: Final evaluation (Week 52 or at discontinuation) and immediately before it ]
4. Efficacy : Mean of percent change from baseline in fasting serum non-HDL-C (mg/dL) at the time of final evaluation* and immediately before it * : Week 52 or at discontinuation [ Time Frame: Final evaluation (Week 52 or at discontinuation) and immediately before it ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Japan

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

Sponsors and Collaborators

Kowa Company, Ltd.

More Information

• Responsible Party: Kowa Company, Ltd.
• ClinicalTrials.gov Identifier: NCT04716595
• Other Study ID Numbers: K-877-ER-03
• First Posted: January 20, 2021
• Last Update Posted: June 18, 2021
• Last Verified: June 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases