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

NCT04714151 | Completed Phase 3

• 1 other identifier: K-877-ER-02
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

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

  4, 8, and 12 week after administration

Secondary Outcomes (4)

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

  4, 8, and 12 week after administration

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

  4, 8, and 12 week after administration

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

  4, 8, and 12 week after administration

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

  4, 8, and 12 week after administration

Study Arms (3)

Treatment A

EXPERIMENTAL

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

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

Treatment B

EXPERIMENTAL

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

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

Control A

ACTIVE COMPARATOR

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

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

Interventions

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

K-877 ER 0.2 mg tablet

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

Treatment A

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

K-877 ER 0.4 mg tablet

Also known as: Pemafibrate ER 0.4 mg/day (once daily)

Treatment B

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

K-877 IR 0.1 mg tablet

Also known as: Pemafibrate IR 0.2 mg/day (twice daily)

Control A

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 \>= 200 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 \[HbA1c(NGSP) \>= 8.0 % at Screening\]
• Patients with uncontrolled hypertension (SBP \>= 160 mmHg or DBP \>= 100 mmHg)
• Patients with an AST or ALT three times the upper limit at Screening
• 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 (11)

Institute Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic

Kanagawa, Japan

Location

Medical Corporation Heishinkai OCROM Clinic

Osaka, Japan

Location

Dojinkinenkai Meiwa Hospital

Tokyo, Japan

Location

Fukuwa Clinic

Tokyo, Japan

Location

Ikebukuro Metropolitan Clinic

Tokyo, Japan

Location

Medical Corp. Seikoukai New Medical Research System Clinic

Tokyo, Japan

Location

Medical Corporation Asbo Tokyo Asbo Clinic

Tokyo, Japan

Location

Medical Corporation Chiseikai Tokyo Center Clinic

Tokyo, Japan

Location

Medical Corporation Heishinkai ToCROM Clinic

Tokyo, Japan

Location

Medical Corporation Yuhokai Miho Clinic

Tokyo, Japan

Location

Tokyo-Eki Center-building Clinic

Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 38616112 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 19, 2021
• Study Start: February 1, 2021
• Primary Completion: September 25, 2021
• Study Completion: September 25, 2021
• Last Updated: June 20, 2024

Record last verified: 2024-06

Locations

JP (11)