A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C

NCT04998981 | Completed Phase 3

• 1 other identifier: K-877-3.01CH
• Study Type: interventional
• Target: 353
• Locations: 1 country
• Sites: 33

Brief Summary

A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients with High TG and Low HDL-C

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

• Percent change in fasting TG versus placebo from baseline to Weeks 8 and 12

  From baseline to Weeks 8 and 12

• Percent change in fasting TG versus fenofibrate from baseline to Weeks 8 and 12

  From baseline to Weeks 8 and 12

Secondary Outcomes (8)

• Percentage of patients who have achieved fasting TG <150 mg/dL at the end of the treatment period

  At Week 12

• Percent change from baseline to Weeks 8 and 12 in TC, LDL-C (direct method), LDL-C (Friedewald method), LDL-C (Martin/Hopkins equation), HDL-C (direct method), non-HDL-C (calculated), and remnant cholesterol (calculated)

  From baseline to Weeks 8 and 12

• Change from baseline to Weeks 8 and 12 in fasting TG, TC, LDL-C (direct method), LDL-C (Friedewald method), LDL-C (Martin/Hopkins equation), HDL-C (direct method), non-HDL-C (calculated), and remnant cholesterol (calculated)

  From baseline to Weeks 8 and 12

• Percent change from baseline to the end of the treatment period in Apo A1 and Apo B

  From baseline to Week 12

• Percent change from baseline to the end of the treatment period in TG/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, LDL-C/HDL-C, LDL-C/Apo B, and Apo B/Apo A1

  From baseline to Week 12

Study Arms (4)

K-877 0.1 mg BID

EXPERIMENTAL

K-877 0.1 mg tablet twice daily, Placebo tablet twice daily, Placebo capsule once daily

Drug: Placebo capsule; Drug: K-877 0.1 mg tablet; Drug: Placebo tablet

K-877 0.2 mg BID

EXPERIMENTAL

K-877 0.1 mg tablet x 2 twice daily, Placebo capsule once daily

Drug: K-877 0.1 mg tablet; Drug: Placebo capsule

Fenofibrate 200 mg QD

ACTIVE COMPARATOR

Fenofibrate 200 mg capsule once daily, Placebo tablet x 2 twice daily

Drug: Fenofibrate 200 mg capsule; Drug: Placebo tablet

Placebo

PLACEBO COMPARATOR

Placcebo tablet x 2 twice daily, Placebo capsule once daily

Drug: Placebo tablet; Drug: Placebo capsule

Interventions

Fenofibrate 200 mg capsule DRUG

Fenofibrate 200 mg capsule once daily

Fenofibrate 200 mg QD

Placebo tablet DRUG

Placebo tablet x 2 twice daily

Also known as: Placebo tablet (matching K-877)

Fenofibrate 200 mg QD; Placebo

Placebo capsule DRUG

Placebo capsule once daily

Also known as: Placebo capsule (matching fenofibrate)

K-877 0.1 mg BID; K-877 0.2 mg BID; Placebo

K-877 0.1 mg tablet DRUG

K-877 0.1 mg tablet x 2 twice daily

Also known as: Pemafibrate

K-877 0.2 mg BID

Eligibility Criteria

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

You may qualify if:

• Subjects are eligible to be included in the study only if all of the following criteria apply:
• Ability to understand and comply with study procedures and give written informed consent
• Following the diet and lifestyle recommendations at least 12 weeks prior to the treatment period
• Males or post-menopausal females
• Aged ≥18 years at the time of informed consent
• Fasting serum TG levels ≥200 mg/dL (≥2.26 mmol/L) and ≤500 mg/dL (5.65 mmol/L) at screening
• Serum HDL-C \<50 mg/dL (\<1.30 mmol/L) if male or \<55 mg/dL (\<1.42 mmol/L) if female at screening.

You may not qualify if:

• Subjects are excluded from the study if any of the following criteria apply:
• Current or planned use of any lipid-altering medications other than the study drugs, statins, or ezetimibe during the study.
• i. Subjects currently on statins or ezetimibe must be at high risk for atherosclerotic CV diseases, and the dose(s) must be stable for at least 4 weeks prior to screening
• ii. For subjects currently on lipid-altering medications other than statins or ezetimibe, at least 4-week washout period (or for subjects currently on probucol at least 8 week washout period) will be required prior to the first fasting blood sampling at Screening Visit
• Type 1 diabetes mellitus or poorly controlled Type 2 diabetes mellitus defined by HbA1c (NGSP level) ≥8.0% at screening
• Uncontrolled hypertension defined by seated systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening
• Uncontrolled thyroid disorder
• Creatinine ≥1.5 mg/dL at screening
• Severe hepatic disorder defined as cirrhosis of Child-Pugh class B or C, or AST or ALT \>2 × ULN at screening
• History of pancreatitis
• Gallbladder disorder, history of cholelithiasis, primary biliary cirrhosis, or history of disease or surgery that may affect the absorption, distribution, metabolism and excretion of drugs or the metabolism of bile salts
• Unexplained creatine kinase (CK) \>5 × ULN at screening
• Myocardial infraction or stroke (including transient ischemic attack) within 3 months prior to the informed consent
• New York Heart Association Class III or IV heart failure
• History of malignancy within 5 years

Sponsors & Collaborators

• Kowa Company, Ltd.: lead

Study Sites (33)

Huainan First People's Hospital

Anhui, 232000, China

Location

Beijing Anzhen Hospital, Capital Medical University

Beijing, 100029, China

Location

Beijing Hospital

Beijing, 100730, China

Location

Beijing Tongren Hospital, Capital Medical University

Beijing, 100730, China

Location

Beijing Pinggu Hospital

Beijing, 101200, China

Location

Chengdu Xinhua Hospital

Chengdu, 610066, China

Location

The First Affiliated Hospital of Fujian Medical University

Fujian, 350005, China

Location

Peking Union Medical College Hospital

Guangdong, 100032, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangdong, 510080, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangdong, 510120, China

Location

The People's Hospital of Guangxi Zhuang Autonomous Region

Guangxi, 530021, China

Location

Hainan General Hospital

Hainan, 570311, China

Location

The Second Hospital of Hebei Medical University

Hebei, 050000, China

Location

The First Affiliated Hospital of Harbin Medical University

Helongjiang, 150001, China

Location

Union Hospital, Tongji Medical College of Huazhong University of Science & Technology

Hubei, 430022, China

Location

Tongji Hospital, Tongji Medical College of HUST

Hubei, 430030, China

Location

Shaanxi Provincial People's Hospital

Hubei, 710068, China

Location

The Third Xiangya Hospital of Central South University

Hunan, 410013, China

Location

The Third Hospital of Changsha

Hunan, 410015, China

Location

Nanjing Jiangning Hospital

Jiangsu, 211100, China

Location

Sir Run Run Hospital Nanjing Medical Universtiy

Jiangsu, 211100, China

Location

Affiliated Hospital of Jiangsu University

Jiangsu, 212001, China

Location

Jiangxi Provincial People's Hospital

Jiangxi, 330006, China

Location

The First Affiliated Hospital of Nanchang University

Jiangxi, 330006, China

Location

The First Hospital of Nanchang

Jiangxi, 330008, China

Location

Jiu Jiang No. 1 People's Hospital

Jiangxi, 332000, China

Location

Pingxiang People's Hospital

Jiangxi, 337055, China

Location

China-Japan Union Hospital of Jilin University

Jilin, 330006, China

Location

Shanghai Tongren Hospital

Shanghai, 200336, China

Location

People's Hospital of Deyang City

Sichuan, 618000, China

Location

Tianjin Union Medical Center

Tianjin, 300121, China

Location

The Affiliated Hospital of Hangzhou Normal University

Zhejiang, 310015, China

Location

People's Hospital of Wenzhou City

Zhejiang, 325000, China

Location

Related Publications (1)

• Dai W, Lv Q, Li Q, Fu L, Zhang Y, Zhang Y, Liu L, Tanigawa R, Kunitomi K, Kamei R, Suganami H, Ma C. Efficacy and Safety of Pemafibrate, a Novel Selective PPARalpha Modulator in Chinese Patients with Dyslipidemia: A Double-Masked, Randomized, Placebo- and Active-Controlled Comparison Trial. J Atheroscler Thromb. 2025 Feb 1;32(2):125-140. doi: 10.5551/jat.64112. Epub 2024 Aug 2.

  PMID: 39098034 RESULT

MeSH Terms

Conditions

Hyperlipidemias

Interventions

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

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

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: July 14, 2021
• First Posted: August 10, 2021
• Study Start: September 17, 2021
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

CN (33)