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

Completed · Phase 2

Conditions studied: Dyslipidemia

In brief

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).

Key facts

Study ID

NCT04447820

Run by

Kowa Research Institute, Inc.

People needed

96

Starts

2020-06-10

Expected to finish

2020-12-03

Last updated by the study team

2023-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pinnacle Research Group — Anniston, Alabama, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Columbus Regional Health — Columbus, Georgia, United States
• Prism Research — Saint Paul, Minnesota, United States
• Diabetes and Endocrinology Consultants, P.C. — Morehead City, North Carolina, United States
• Medpace Clinical Pharmacology, LLC — Cincinnati, Ohio, United States
• Aventiv Research, Inc. — Columbus, Ohio, United States
• Summit Research Group, LLC — Munroe Falls, Ohio, United States
• Health Concepts — Rapid City, South Dakota, United States
• Clinical Trials of Texas, Inc. — San Antonio, Texas, United States
• Manassas Clinical Research Center — Manassas, Virginia, United States

Full record on ClinicalTrials.gov

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