Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR

• Status: Completed
• Trial end date: 2020-12-03
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kowa Research Institute, Inc.

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