Phase 2
Completed N=96
Study to Investigate the Efficacy and Pharmacokinetic Profile of K-877-ER Compared to K-877-IR
Source: ClinicalTrials.gov NCT04447820 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Estimated Percentage Change in Fasting Triglyceride(s) (TG) — -41.57; -36.79; -38.94 Percent Change — p=0.3084
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimated Percentage Change in Fasting Triglyceride(s) (TG) |
-41.57; -36.79; -38.94 | 0.3084 |
| SECONDARY Percentage Change From Baseline to Day 28 in Total Cholesterol (TC) |
-6.07; -8.68; 0.28 | 0.9788 |
| SECONDARY Percentage Change From Baseline to Day 28 in Low-density Lipoprotein Cholesterol (LDL-C) |
3.56; -2.16; 22.71 | 0.8840 |
| SECONDARY Percentage Change From Baseline to Day 28 in High-density Lipoprotein Cholesterol (HDL-C) |
12.22; 15.39; 20.04 | 0.9353 |
| SECONDARY Percentage Change From Baseline to Day 28 in Remnant Cholesterol |
-33.85; -30.08; -32.34 | 0.2098 |
| SECONDARY Percentage Change From Baseline to Day 28 in Non-HDL-C |
-10.04; -11.12; -3.74 | 0.5647 |
| SECONDARY Percentage Change From Baseline to Day 28 in Free Fatty Acid (FFAs) |
-7.35; -17.17; -10.22 | 0.2562 |
| SECONDARY K-877 PK Parameters Cmax |
2.061; 2.746; 5.433 | — |
| SECONDARY K-877 PK Parameters AUC (Tau) |
10.239; 22.566; 41.611 | — |
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
Data sourced from ClinicalTrials.gov (NCT04447820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.