Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR
Sponsored by Kowa Research Institute, Inc.
About this trial
Last updated 4 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 5 years ago
What is this trial about?
What are the participation requirements?
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