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

Phase 3

Completed

• Conditions: Dyslipidemias
• Interventions: Drug: K-877 ER 0.2 mg/day evening administration (once daily); Drug: K-877 ER 0.2 mg/day morning administration (once daily)

• Registration Number: NCT04716595
• Lead Sponsor: Kowa Company, Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-01-15
• Study First Posted: 2021-01-20
• Study Start: 2021-02-01
• Primary Completion: 2022-06-13
• Study Completion: 2022-07-29
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
evening administration	K-877 ER 0.2 mg/day evening administration (once daily)	K-877 ER 0.2 mg/day evening administration (once daily)
morning administration	K-877 ER 0.2 mg/day morning administration (once daily)	K-877 ER 0.2 mg/day morning administration (once daily)

Primary Outcome Measures

Name	Time	Method
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	Final evaluation (Week 52 or at discontinuation) and immediately before it

Secondary Outcome Measures

Name	Time	Method
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	Final evaluation (Week 52 or at discontinuation) and immediately before it
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	Final evaluation (Week 52 or at discontinuation) and immediately before it
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	Final evaluation (Week 52 or at discontinuation) and immediately before it
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	Final evaluation (Week 52 or at discontinuation) and immediately before it

Trial Locations

Locations (14)

Kyosokai AMC NISHI-UMEDA Clinic; 🇯🇵 Osaka, Japan

Shiraiwa medical clinic; 🇯🇵 Osaka, Japan

Cosmos medical corporation Aozora total clinic; 🇯🇵 Saitama, Japan

Japan Community Health care Organization Hokkaido Hospital; 🇯🇵 Hokkaido, Japan

Saiseikai Futsukaichi Hospital; 🇯🇵 Fukuoka, Japan

Hasegawa Medicine Clinic; 🇯🇵 Hokkaido, Japan

Kinugawa Cardiology Clinic; 🇯🇵 Osaka, Japan

Akasaka Chuou Clinic; 🇯🇵 Tokyo, Japan

National Hospital Organization Takasaki General Medical Center; 🇯🇵 Gunma, Japan

Medical corporation Tani clinic; 🇯🇵 Osaka, Japan

Minami Akatsuka Clinic; 🇯🇵 Ibaraki, Japan

Saiseikai Yokohamashi Nanbu Hospital; 🇯🇵 Kanagawa, Japan

Medical Corporation Chiseikai Tokyo Center Clinic; 🇯🇵 Tokyo, Japan

Shimokitazawa Tomo Clinic; 🇯🇵 Tokyo, Japan