Efficacy and Safety of K-877 (Pemafibrate), a Selective PPARα Modulator, in European Patients on Statin Therapy
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Abstract
OBJECTIVE: High plasma triglyceride (TG) is an independent risk factor for cardiovascular disease. Fibrates lower TG levels through peroxisome proliferator–activated receptor α (PPARα) agonism. Currently available fibrates, however, have relatively low selectivity for PPARα. The aim of this trial was to assess the safety, tolerability, and efficacy of K-877 (pemafibrate), a selective PPARα modulator, in statin-treated European patients with hypertriglyceridemia. RESEARCH DESIGN AND METHODS: A total of 408 statin-treated adults were recruited from 68 European sites for this phase 2, randomized, double-blind, placebo-controlled trial. They had fasting TG between 175 and 500 mg/dL and HDL-cholesterol (HDL-C) ≤50 mg/dL for men and ≤55 mg/dL for women. Participants were randomly assigned to receive placebo or one of six pemafibrate regimens: 0.05 mg twice a day, 0.1 mg twice a day, 0.2 mg twice a day, 0.1 mg once daily, 0.2 mg once daily, or 0.4 mg once daily. The primary end points were TG and non–HDL-C level lowering at week 12. RESULTS: Pemafibrate reduced TG at all doses (adjusted P value <0.001), with the greatest placebo-corrected reduction from baseline to week 12 observed in the 0.2-mg twice a day treatment group (54.4%). Reductions in non–HDL-C did not reach statistical significance. Reductions in TG were associated with improvements in other markers for TG-rich lipoprotein metabolism, including reductions in apoB48, apoCIII, and remnant cholesterol and an increase in HDL-C levels. Pemafibrate increased LDL-cholesterol levels, whereas apoB100 was unchanged. Pemafibrate was safe and well-tolerated, with only minor increases in serum creatinine and homocysteine concentrations. CONCLUSIONS: Pemafibrate is effective, safe, and well-tolerated for the reduction of TG in European populations with hypertriglyceridemia despite statin treatment.
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Phase 2 studies showed that pemafibrate had greater triglyceride-lowering and HDL cholesterol-raising actions with fewer off-target effects than PPARα agonists such as fenofibrate.
“Phase 2 studies have shown that, as compared with PPARα agonists such as fenofibrate, pemafibrate had greater triglyceride-lowering and HDL cholesterol-raising actions with fewer off-target effects. 9-14”
From Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk (2022) · cites this paper as [14]
The Results and Secondary End Points report triglyceride reductions and HDL-C increases with pemafibrate versus placebo. The Conclusions report smaller homocysteine increases and fewer treatment-related adverse events than reported for fenofibrate. This placebo-controlled trial does not establish that pemafibrate lowers triglycerides or raises HDL-C more than fenofibrate. (LLM, conf=0.86)
Experimental — accuracy not yet measuredPemafibrate reduces triglyceride levels and improves other lipid levels.
“Pemafibrate, a selective peroxisome proliferator-activated receptor α modulator, reduces triglyceride levels and improves other lipid levels.”
From Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk (2022) · cites this paper as [14]
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- Arai H, Yamashita S, Yokote K, Araki E, Suganami H, Ishibashi S. Efficacy and safety of K-877, a novel selective peroxisome proliferator- activated receptor alpha modulator (SPPARM- alpha), in combination with statin treatment. Atherosclerosis 2017;261:144-152
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Furuya, T., Kitahama, S., Ogawa, S., Tamura, Y., & Yasu, T. (2025) · Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics · doi:10.3999/jscpt.56.3_142
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- Authors
- Ginsberg, H. N., Hounslow, N. J., Senko, Y., Suganami, H., Bogdanski, P., Ceska, R., Kalina, A., Libis, R. A., Supryadkina, T. V., & Hovingh, G. K.
- Affiliations
- Columbia University (US)
- Kowa (United Kingdom) (GB)
- Kowa (Japan) (JP)
- Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznan University of Medical Sciences, Poznan, Poland
- Department of Internal Medicine, Charles University and University General Hospital, Prague, Czech Republic
- Hungarian Defense Forces Medical Centre, Budapest, Hungary
- Orenburg State Medical Academy (RU)
- First City Clinical Hospital named after E.E. Volosevitch, Arkhangelsk, Russia
- Amsterdam University Medical Centers (NL)
- Corresponding author
- Ginsberg, Henry N.
- ORCID
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2022-03-25
- Volume
- 45
- Issue
- 4
- Pages
- 898-908
- ISSN
- 0149-5992 (ISSN-L)
- OpenAlex
- W4214806971
- Cited by
- 48
- References
- 46
- Citations by year
- 2026: 4 · 2025: 11 · 2024: 12 · 2023: 15 · 2022: 6
- FWCI
- 10.74
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Diabetes Care (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- Medpace
- Kowa Company
- University of California, San Francisco
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Peroxisome Proliferator-Activated Receptors
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Keywords
- pemafibrate, PPARα agonist, hypertriglyceridemia, triglyceride lowering, statin-treated patients, non-HDL cholesterol, HDL cholesterol, apolipoprotein C-III, apolipoprotein B-48, remnant cholesterol, LDL cholesterol, drug safety and tolerability, fibrates
- MeSH terms
- Adult, Benzoxazoles, Butyrates, Double-Blind Method, Female, Humans, Male, Triglycerides, Hypertriglyceridemia, Hydroxymethylglutaryl-CoA Reductase Inhibitors, PPAR alpha, Fibric Acids
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