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

Kowa

Status and phase: Completed; Phase 3

Conditions: Hyperlipidemia

Treatments: Drug: Placebo tablet; Drug: K-877 0.1 mg tablet; Drug: Placebo capsule; Drug: Fenofibrate 200 mg capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT04998981

K-877-3.01CH

Details and patient eligibility

About

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

Enrollment: 353 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects are eligible to be included in the study only if all of the following criteria apply:

1. Ability to understand and comply with study procedures and give written informed consent
2. Following the diet and lifestyle recommendations at least 12 weeks prior to the treatment period
3. Males or post-menopausal females
4. Aged ≥18 years at the time of informed consent
5. Fasting serum TG levels ≥200 mg/dL (≥2.26 mmol/L) and ≤500 mg/dL (5.65 mmol/L) at screening
6. Serum HDL-C <50 mg/dL (<1.30 mmol/L) if male or <55 mg/dL (<1.42 mmol/L) if female at screening.

Exclusion criteria

Subjects are excluded from the study if any of the following criteria apply:

1. 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

2. Type 1 diabetes mellitus or poorly controlled Type 2 diabetes mellitus defined by HbA1c (NGSP level) ≥8.0% at screening

3. Uncontrolled hypertension defined by seated systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening

4. Uncontrolled thyroid disorder

5. Creatinine ≥1.5 mg/dL at screening

6. Severe hepatic disorder defined as cirrhosis of Child-Pugh class B or C, or AST or ALT >2 × ULN at screening

7. History of pancreatitis

8. 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

9. Unexplained creatine kinase (CK) >5 × ULN at screening

10. Myocardial infraction or stroke (including transient ischemic attack) within 3 months prior to the informed consent

11. New York Heart Association Class III or IV heart failure

12. History of malignancy within 5 years

13. Participation in another clinical study at the time of informed consent or administration of an investigational drug other than placebo within 16 weeks prior to the informed consent for this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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353 participants in 4 patient groups, including a placebo group

K-877 0.1 mg BID

Experimental group

Description:

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

Treatment:

Drug: Placebo tablet

Drug: Placebo capsule

Drug: K-877 0.1 mg tablet

Drug: K-877 0.1 mg tablet

Drug: Placebo tablet

K-877 0.2 mg BID

Experimental group

Description:

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

Treatment:

Drug: Placebo capsule

Drug: K-877 0.1 mg tablet

Drug: K-877 0.1 mg tablet

Fenofibrate 200 mg QD

Active Comparator group

Description:

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

Treatment:

Drug: Placebo tablet

Drug: Fenofibrate 200 mg capsule

Drug: Placebo tablet

Placebo

Placebo Comparator group

Description:

Placcebo tablet x 2 twice daily, Placebo capsule once daily

Treatment:

Drug: Placebo tablet

Drug: Placebo capsule

Drug: Placebo tablet