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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | K-877 (pemafibrate) tablet twice daily. |
|
| Control Group | Placebo Comparator | placebo tablet twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K-877 | Drug | 0.2mg tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: % Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) | Week 24 | |
| Safety: Incidence of adverse events and adverse drug reactions that occurred after the administration of the study drug | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in noninvasive imaging biomarkers (MRI-PDFF in %, MRE in kPa, Transient elastography in kPa) | From baseline upto week 72 | |
| Change in clinical laboratory tests (AST in IU/L, ALT in IU/L, γ-GTP in IU/L) | From baseline upto week 72 |
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Inclusion Criteria:
Exclusion Criteria:
Current of significant alcohol consumption (significant alcohol consumption is defined as more than 210 g/week in males and more than 140 g/week in females, on average)
Planned use of Contraindicated Medications from written ICF to end of treatment.
BMI < 22 kg/m2 at Screening
Uncontrolled diabetes mellitus as defined by a HbA1c(NGSP) ≥ 8.0% at Screening
eGFR < 30 mL/min/1.73m2 or Dialysis patient
Cirrhosis
Biliary obstruction
Patients were excluded if they had evidence of other forms of liver disease shown by the following:
Those with complicating malignant neoplasm or those judged to be at a high risk of recurrence
Patients with contraindications to MRI imaging
Patients who gave 200 mL or more of blood within 1 month before the administration of the study drug, or 400 mL or more of blood within 4 months before the administration of the study drug
Patients with a history of serious drug allergies (such as anaphylactic shock)
Pregnancy, breast feeding, planned pregnancy
Patients who were participating in another clinical study at the time of consent was obtained or who received study drugs other than the placebo less than 16 weeks before consent was obtained
Patients who have previously been administered pemafibrate
Patients who have been determined inappropriate by the investigator or subinvestigator
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| Name | Affiliation | Role |
|---|---|---|
| Ryohei Tanigawa | Clinical Development Dept. Ⅰ | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aomori Prefectural Central Hospital | Aomori, Aomori | 030-8553 | Japan | |||
| Asahikawa Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41953251 | Derived | Tanigawa R, Loomba R, Eguchi Y, Takahashi H, Suganami H, Tanahashi M, Belous A, Nakajima A. Post Hoc Analysis of a Phase 2 Randomized Trial of Pemafibrate in Metabolic Dysfunction-associated Steatotic Liver Disease: Associations With Platelet Count, Liver Stiffness, and Spleen Volume. J Clin Exp Hepatol. 2026 Jul-Aug;16(4):103525. doi: 10.1016/j.jceh.2026.103525. Epub 2026 Mar 3. | |
| 34528723 |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000603947 | K-877 compound |
| C540740 | (R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid |
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| Placebo | Drug | K-877 matching placebo tablet |
|
| Change in noninvasive biomarkers (Cytokeratin 18 in U/L, Hyaluronic acid in ng/mL, Type IV collagen 7S in ng/mL, M2BPGi in no unit) | From baseline upto week 72 |
| Change in noninvasive biomarkers (NAFLD fibrosis score) | From baseline upto week 72 |
| Change in noninvasive biomarkers (FIB4 index) | From baseline upto week 72 |
| Change in noninvasive biomarkers (NAFIC score) | From baseline upto week 72 |
| Change in noninvasive biomarkers (ELF test) | From baseline upto week 72 |
| Percentage of patients with ≥ 30% reduction in hepatic fat fraction (MRI-PDFF) | From baseline upto week 72 |
| Percentage of patients with ≥ 15% reduction in liver stiffness (MRE) | From baseline upto week 72 |
| Asahikawa, Hokkaido |
| 078-8510 |
| Japan |
| Fukuwa Clinic | Chuo-ku, Tokyo | 104-0031 | Japan |
| Fukuoka University Hospital | Fukuoka, Fukuoka | 814-0180 | Japan |
| SeireiHamamatsu General Hospital | Hamamatsu, Shizuoka | 430-8558 | Japan |
| Hamamatsu University Hospital | Hamamatsu, Shizuoka | 431-3192 | Japan |
| Iwata City Hospital | Iwata, Shizuoka | 438-8550 | Japan |
| Chutoen General Medical Center | Kakegawa, Shizuoka | 436-8555 | Japan |
| Kurume University Hospital | Kurume, Fukuoka | 830-0011 | Japan |
| Niigata University Medical & Dental Hospital | Niigata, Niigata | 951-8520 | Japan |
| Ogaki Municipal Hospital | Ogaki, Gifu | 503-8502 | Japan |
| Shiga University of Medical Science Hospital | Otsu, Shiga | 520-2192 | Japan |
| Hokkaido University Hospital | Sapporo, Hokkaido | 060-8648 | Japan |
| Yamagata University Hospital | Yamagata, Yamagata | 990-9585 | Japan |
| Saiseikai Yokohamashi Tobu Hospital | Yokohama, Kanagawa | 230-8765 | Japan |
| Yokohama City University Hospital | Yokohama, Kanagawa | 236-0004 | Japan |
| Derived |
| Nakajima A, Eguchi Y, Yoneda M, Imajo K, Tamaki N, Suganami H, Nojima T, Tanigawa R, Iizuka M, Iida Y, Loomba R. Randomised clinical trial: Pemafibrate, a novel selective peroxisome proliferator-activated receptor alpha modulator (SPPARMalpha), versus placebo in patients with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2021 Nov;54(10):1263-1277. doi: 10.1111/apt.16596. Epub 2021 Sep 16. |
| 33392801 | Derived | Fruchart JC, Hermans MP, Fruchart-Najib J, Kodama T. Selective Peroxisome Proliferator-Activated Receptor Alpha Modulators (SPPARMalpha) in the Metabolic Syndrome: Is Pemafibrate Light at the End of the Tunnel? Curr Atheroscler Rep. 2021 Jan 3;23(1):3. doi: 10.1007/s11883-020-00897-x. |