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NCT04079530
A Clinical Pharmacology Study of K-877 Controlled Release Tablet
Phase 2 trial testing K-877 IR 0.2 mg/day in Dyslipidemias in 60 participants. Completed in 24 December 2019.
24 December 2019
Quick facts
| Lead sponsor | Kowa Company, Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 13 September 2019 |
| Primary completion | 24 December 2019 |
| Estimated completion | 24 December 2019 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- K-877 IR 0.2 mg/day — full drug profile →
- K-877 CR 0.4 mg/day — full drug profile →
- K-877 CR 0.8 mg/day — full drug profile →
Conditions studied
- Dyslipidemias — all drugs for Dyslipidemias →
Sponsor
Kowa Company, Ltd. — full company profile →
Who can join
20 and older, any sex, with Dyslipidemias. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A study to compare the efficacy, safety, and pharmacokinetics of K-877 controlled release tablets with a current normal K-877 tablet in dyslipidemia.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Clinical Pharmacology of Pemafibrate Extended-release Formulation in Patients with Hypertriglyceridemia-A Phase 2, Multicenter, Active-controlled, Randomized, Single-blind, Crossover study.
Yamashita S, Araki E, Arai H, Yokote K, et al · · 2025 · cited 2× · PMID 39322570 · DOI 10.5551/jat.65001
Verify or expand the search:
- PubMed search for NCT04079530
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Kowa Company, Ltd. trials
Trials by the same sponsor.
- NCT05923281 — A Phase III Confirmatory Study of K-877 (Pemafibrate) in Patients With Hypercholesterolemia and Statin Intolerance · Phase 3 · completed
- NCT05056883 — A Phase III Confirmatory Study of K-237 · Phase 3 · completed
- NCT04998981 — A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C · Phase 3 · completed
- NCT04714151 — A Phase III Confirmatory Study of K-877 Extended Release Tablet · Phase 3 · completed
- NCT04716595 — A Phase III Long Term Study of K-877 Extended Release Tablet · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04079530 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kowa Company, Ltd.
- Last refreshed: 6 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04079530.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing