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

NCT04716595 | Completed Phase 3

• 1 other identifier: K-877-ER-03
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 14

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

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (4)

• 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

Study Arms (2)

morning administration

EXPERIMENTAL

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

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

evening administration

EXPERIMENTAL

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

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

Interventions

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

K-877 ER 0.2 mg tablet

Also known as: Pemafibrate ER 0.2 mg/day morning administration (once daily)

morning administration

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

K-877 ER 0.2 mg tablet

Also known as: Pemafibrate ER 0.2 mg/day evening administration (once daily)

evening administration

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \>= 150 mg/dL twice consecutively at Screening

You may not qualify if:

• 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 \[HbA1c(NGSP) \>= 10.0 % at Screening\]
• Patients with uncontrolled hypertension (SBP \>= 160 mmHg or DBP \>= 100 mmHg)
• Patients with an AST or ALT three times the upper limit at Screening
• 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)

Sponsors & Collaborators

• Kowa Company, Ltd.: lead

Study Sites (14)

Saiseikai Futsukaichi Hospital

Fukuoka, Japan

Location

National Hospital Organization Takasaki General Medical Center

Gunma, Japan

Location

Hasegawa Medicine Clinic

Hokkaido, Japan

Location

Japan Community Health care Organization Hokkaido Hospital

Hokkaido, Japan

Location

Minami Akatsuka Clinic

Ibaraki, Japan

Location

Saiseikai Yokohamashi Nanbu Hospital

Kanagawa, Japan

Location

Kinugawa Cardiology Clinic

Osaka, Japan

Location

Kyosokai AMC NISHI-UMEDA Clinic

Osaka, Japan

Location

Medical corporation Tani clinic

Osaka, Japan

Location

Shiraiwa medical clinic

Osaka, Japan

Location

Cosmos medical corporation Aozora total clinic

Saitama, Japan

Location

Akasaka Chuou Clinic

Tokyo, Japan

Location

Medical Corporation Chiseikai Tokyo Center Clinic

Tokyo, Japan

Location

Shimokitazawa Tomo Clinic

Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 39924184 RESULT

MeSH Terms

Conditions

Dyslipidemias

Interventions

(R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 20, 2021
• Study Start: February 1, 2021
• Primary Completion: June 13, 2022
• Study Completion: June 13, 2022
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

JP (14)