NCT05923281

Brief Summary

To investigate the efficacy and safety of K-877 Extended Release 0.2 mg/day or 0.4 mg/day for 12 weeks in patients with Statin Intolerant\* Hypercholesterolemia,using placebo as a controll. \*Statin Intolerant: Adverse events associated with statin use that cause unacceptable disturbances in the user's daily life, resulting in drug discontinuation or dose reduction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2024

Completed
Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

1.3 years

First QC Date

June 20, 2023

Last Update Submit

December 9, 2025

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Percent change from baseline in LDL-C (formula F).

    Percent change = (measured value at each time point - baseline value) / baseline value

    4, 8, and 12 weeks after administration

Secondary Outcomes (6)

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

    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

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

    4, 8, and 12 week after administration

  • Efficacy: % change from baseline in fasting serum LDL-C（formula F）/HDL-C

    4, 8, and 12 week after administration

  • +1 more secondary outcomes

Study Arms (3)

Treatment A

EXPERIMENTAL

K-877 0.2 mg/day

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

Treatment B

EXPERIMENTAL

K-877 0.4 mg/day

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

Control A

PLACEBO COMPARATOR

Placebo

Drug: Placebo (once daily)

Interventions

Placebo (once daily)DRUG

Placebo tablet

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

K-877 0.2mg tablet

Also known as: Pemafibrate 0.2mg/day (once daily)
Treatment A
K-877 0.4 mg/day (once daily)DRUG

K-877 0.2mg tablet

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients had to be age 18 years or older at written informed consent
  • Patients with statin intolerant hypercholesterolemia
  • Patients who have laboratory records with fasting serum TG \<= 150 mg/dL (\<=175 mg/dL when not fasting) within 6 months prior to consent.
  • Patients with the fasting serum TG \<= 150 mg/dL at screening
  • Patients who have received dietary or exercise guidance from 12 weeks or more prior to Screening
  • Patients who apply any of the following risk category with LDL-C level (Friedewald formula) based on JAS2022 at screening
  • Low risk for primary prevention: LDL-C \>=160 mg/dL
  • Intermediate risk for primary prevention: LDL-C \>=140 mg/dL
  • High risk for primary prevention: LDL-C\>=120 mg/dL
  • Secondary prevention: LDL-C\>=120 mg/dL

You may not qualify if:

  • Patients who require administration of prohibited drugs during the clinical trial period after written informed consent
  • Patients with type 1 diabetes and uncontrolled diabetes \[HbA1c(NGSP) \>= 10.0 % at Screening\]
  • Patients with uncontrolled thyroid disease
  • Patients with undergoing LDL apheresis
  • Patients with cirrhosis or those with biliary obstruction
  • Patients with familial hypercholesterolemia (homozygotes)
  • Patients with uncontrolled hypertension (SBP \>= 160 mmHg or DBP \>= 100 mmHg) at Screening
  • Patients with an AST or ALT three times the upper limit at Screening
  • Patients with an CK four times the upper limit at Screening
  • Patients with any of the following criteria within 3 months before obtaining informed consent: myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass surgery, stroke, transient ischemic attack, symptomatic carotid artery stenosis, symptomatic peripheral arterial disease, abdominal aortic aneurysm, uncontrolled severe arrhythmia and decompensated heart failure
  • Patients who plan to undergo PCI, CABG, carotid artery or peripheral revascularization
  • 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 myopathy or rhabdomyolysis due to K-877 (pemafibrate)
  • Patients with a history of hypersensitivity due to K-877 (pemafibrate)
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Nakayama Clinic

Aichi, Japan

Location

Kohnodai Hospital, National Center for Global Health and Medicine

Chiba, Japan

Location

Tashiro Endocrinology Clinic

Fukuoka, Japan

Location

Central Japan International Medical Center

Gifu, Japan

Location

NTT Medical Center Sapporo

Hokkaido, Japan

Location

Tsukuba Medical Center Foundation Tsukuba Medical Center Hospital

Ibaraki, Japan

Location

Yokohama Minami Kyosai Hospital

Kanagawa, Japan

Location

Kumamoto University Hospital

Kumamoto, Japan

Location

Medical Corporation LONGWOOD Maeda Clinic

Osaka, Japan

Location

OCROM Clinic

Osaka, Japan

Location

Rinku General Medical Center

Osaka, Japan

Location

Koshigaya Municipal Hospital

Saitama, Japan

Location

Saitama Medical University Hospital

Saitama, Japan

Location

Affiliated CENTRAL CLINIC of Higashiyamato Hospital

Tokyo, Japan

Location

Fukuwa Clinic

Tokyo, Japan

Location

Juntendo University Hospital

Tokyo, Japan

Location

Medical Corporation Chiseikai Tokyo Center Clinic

Tokyo, Japan

Location

Mishuku Hospital

Tokyo, Japan

Location

Seiwa Clinic

Tokyo, Japan

Location

ToCROM Clinic

Tokyo, Japan

Location

Tokyo Heart Summit Tokyo Heart Rhythm Hospital

Tokyo, Japan

Location

Tokyo-Eki Center-building Clinic

Tokyo, Japan

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

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

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional 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

June 20, 2023

First Posted

June 28, 2023

Study Start

May 1, 2023

Primary Completion

August 7, 2024

Study Completion

August 7, 2024

Last Updated

December 11, 2025

Record last verified: 2025-12

Locations

JP(22)