A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C
NCT04998981 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 353
Last updated 2025-05-23
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
Interventions
- DRUG
-
K-877 0.1 mg tablet
K-877 0.1 mg tablet x 2 twice daily
- DRUG
-
Fenofibrate 200 mg capsule
Fenofibrate 200 mg capsule once daily
- DRUG
-
Placebo tablet
Placebo tablet x 2 twice daily
- DRUG
-
Placebo capsule
Placebo capsule once daily
- DRUG
-
K-877 0.1 mg tablet
K-877 0.1 mg tablet twice daily
- DRUG
-
Placebo tablet
Placebo tablet twice daily
Sponsors & Collaborators
-
Kowa Company, Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-17
- Primary Completion
- 2023-02-02
- Completion
- 2023-02-02
Countries
- China
Study Locations
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