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Clinical trial

A Multicenter, Randomized, Open-Label, 4-Week Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Once Daily Treatment Compared to K-877-IR Twice Daily Treatment in Adult Patients With Fasting Triglyceride Levels

ID
Name
K-877-ER-201
Description
A study to evaluate the efficacy of K-877 extended release (ER) once daily (QD) compared to K-877 immediate release (IR) twice daily (BID).
Trial arms
Trial start
2020-06-10
Estimated PCD
2020-12-03
Trial end
2020-12-03
Status
Completed
Phase
Early phase I
Treatment
K-877-ER (Dose A)
Dose A Oral Administration
Arms:
K-877-ER Dose A
K-877-ER (Dose B)
Dose B Oral Administration
Arms:
K-877-ER Dose B
K-877-IR
K-877-IR Oral Administration
Arms:
K-877-IR
Size
96
Primary endpoint
Estimated Percentage Change in Fasting Triglyceride(s) (TG)
Baseline to Day 28
Eligibility criteria
Inclusion Criteria: * Able to provide written informed consent before any study-specific evaluation is performed * At screening, have a mean fasting TG level of ≥180 mg/dL and \<550 mg/dL; at subsequent Qualification Period visits confirm fasting TG level of ≥200 mg/dL and \<500 mg/dL * Able to meet all inclusion criteria outlined in clinical study protocol Exclusion Criteria: * Require lipid-altering treatments other than study drugs, statins, ezetimibe, or PCSK9 inhibitors during the study * Known hypersensitivity or intolerance to fibrates or peroxisome proliferator-activated receptor alpha agonists * Meet any other exclusion criteria outlined in clinical study protocol
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 96, 'type': 'ACTUAL'}}
Updated at
2023-12-22

1 organization

3 products

1 indication

Organization
Kowa Research Institute
Product
K-877-ER
Indication
lipid metabolism disorder
Product
K-877-IR
Product
K-877