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Non-Alcoholic Fatty Liver DiseasePhase 2NCT03350165

A Study of Pemafibrate in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)

A Phase 2 study testing K-877 in people with Non-Alcoholic Fatty Liver Disease, run by Kowa Company, Ltd. at 16 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Non-Alcoholic Fatty Liver Disease
What is being tested?
K-877
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
118 participants
Where
16 sitesJapan
Study dates
27 Dec 2017to 30 Jun 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients show presence of hepatic fat fraction as defined by ≥ 10% on MRI-PDFF at Screening
  • Patients show presence of liver stiffness as defined by ≥ 2.5 kPa on MRE at Screening
  • Patients have an ALT above the upper limits of normal (30 IU/L for females and 40 IU/L for males) at Screening
  • Patients with NAFLD had to be age 20 years or older at written informed consent(ICF)

Who cannot join

  • 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
Show all 22Show fewer
  • Biliary obstruction
  • Patients were excluded if they had evidence of other forms of liver disease shown by the following:
  • Hepatitis B or Hepatitis C
  • Autoimmune hepatitis（AIH）
  • Primary biliary cirrhosis（PBC）
  • Primary Sclerosing Cholangitis（PSC）
  • Drug-induced liver injury
  • hyperthyroidism, Wilson's disease, hemochromatosis, alpha-1-antitrypsin disease
  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Japan16 sites

  • Aomori Prefectural Central Hospital

    Aomori, Aomori, 030-8553

  • Asahikawa Medical University

    Asahikawa, Hokkaido, 078-8510

  • Fukuwa Clinic

    Chuo-ku, Tokyo, 104-0031

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • SeireiHamamatsu General Hospital

    Hamamatsu, Shizuoka, 430-8558

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192

  • Iwata City Hospital

    Iwata, Shizuoka, 438-8550

  • Chutoen General Medical Center

    Kakegawa, Shizuoka, 436-8555

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

  • Niigata University Medical & Dental Hospital

    Niigata, Niigata, 951-8520

  • Ogaki Municipal Hospital

    Ogaki, Gifu, 503-8502

  • Shiga University of Medical Science Hospital

    Otsu, Shiga, 520-2192

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Yamagata University Hospital

    Yamagata, Yamagata, 990-9585

  • Saiseikai Yokohamashi Tobu Hospital

    Yokohama, Kanagawa, 230-8765

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

About this study

Official title: 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.

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.

Being tested
K-877, Placebo
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • K-877Drug

    Also called pemafibrate

    0.2mg tablet

  • PlaceboDrug

    K-877 matching placebo tablet

Study groups in NCT03350165
Study groupRoleWhat they receive
Treatment GroupExperimentalK-877 (pemafibrate) tablet twice daily.
Receives: Drug: K-877
Control GroupPlacebo comparatorplacebo tablet twice daily.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy: % Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)

    Measured: Week 24

  2. Safety: Incidence of adverse events and adverse drug reactions that occurred after the administration of the study drug

    Measured: Week 24

Secondary outcomes (9)

  1. Change in noninvasive imaging biomarkers (MRI-PDFF in %, MRE in kPa, Transient elastography in kPa)

    Measured: From baseline upto week 72

  2. Change in clinical laboratory tests (AST in IU/L, ALT in IU/L, γ-GTP in IU/L)

    Measured: From baseline upto week 72

  3. 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)

    Measured: From baseline upto week 72

  4. Change in noninvasive biomarkers (NAFLD fibrosis score)

    Measured: From baseline upto week 72

  5. Change in noninvasive biomarkers (FIB4 index)

    Measured: From baseline upto week 72

  6. Change in noninvasive biomarkers (NAFIC score)

    Measured: From baseline upto week 72

  7. Change in noninvasive biomarkers (ELF test)

    Measured: From baseline upto week 72

  8. Percentage of patients with ≥ 30% reduction in hepatic fat fraction (MRI-PDFF)

    Measured: From baseline upto week 72

  9. Percentage of patients with ≥ 15% reduction in liver stiffness (MRE)

    Measured: From baseline upto week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2017
  2. Study start27 Dec 2017
  3. Primary completion3 Apr 2019
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03350165
Sponsor's protocol ID
K-877-FL-01
Status last verified
Apr 2021
First submitted
9 Nov 2017
Last updated
9 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tanigawa R, Loomba R, Eguchi Y, Takahashi H, Suganami H, Belous A, Nakajima A. Differential Modulation of Serum Albumin and Butyrylcholinesterase Following Pemafibrate Treatment in MASLD: A Post Hoc Analysis of the PEMA-FL Trial. Metabolites. 2026 Oct 6;16(10):750. doi: 10.3390/metabo16100750.

    PubMed 42941225

  • 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.

    PubMed 41953251

  • 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.

    PubMed 34528723

  • 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.

    PubMed 33392801

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing K-877 in people with Non-Alcoholic Fatty Liver Disease, run by Kowa Company, Ltd. at 16 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy: % Change from baseline to Week 24 in hepatic fat fraction by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03350165, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.

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