Non Alcoholic Fatty Liver DiseasePhase 2NCT06623539
Efficacy and Safety of Pemafibrate for Nonalcoholic Fatty Liver Disease
A Phase 2 study testing Pemafibrate high dose, Pemafibrate low dose and Fenofibrate in people with Non Alcoholic Fatty Liver Disease, run by Yokohama City University at 1 site in Japan.
Trial summary
This is a study to evaluate the effect of pemafibrate on fatty liver in patients with hypertgemia combined with NAFLD, using fenofibrate as a control. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Non Alcoholic Fatty Liver Disease
- What is being tested?
- Pemafibrate high dose, Pemafibrate low dose and Fenofibrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteJapan
- Study dates
- 23 Dec 2020to Mar 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women at least 20 years old and under 80 years old at the time of obtaining consent.
- Patients with fatty liver diagnosed histologically within 1 year prior to obtaining consent or imaging examination within 6 months prior to obtaining consent and who have failed exercise and diet therapy for at least 3 months.
- Patients with hypertriglyceridemia (150-500 mg/dl) within 91 days prior to obtaining consent.
- Patients with elevated ALT (43-100 IU/L for men, 24-100 IU/L for women) within 91 days prior to obtaining consent.
- Patients whose daily alcohol consumption (ethanol equivalent) is less than 30 grams per day for men and less than 20 grams per day for women at the time of obtaining consent.
- Patients with hepatitis C, hepatitis B (excluding inactive carriers), autoimmune hepatitis, primary biliary cholangitis, or other hepatic complications that have been ruled out at the time of obtaining consent.
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- Patients whose written consent to participate in this study has been obtained. [Basis for settings]
- 1） The age range was set to 20 years or older because the safety of the study drug has not been established in children. In addition, the age of patients was set to be less than 80 years considering safety and the susceptible age of NAFLD/NASH onset.
- 2） This is because the 2014 NAFLD/NASH guideline states that \"fatty liver is present on histology or imaging\" regarding NAFLD definition.
- 3） Within dyslipidemia patients, those with hypertriglyceridemia and indicated for fibrates will be used as controls.
- Since TG\>500 poses a risk of developing acute pancreatitis, the selection criteria were TG levels between 150 and 500 mg/dl.
- 4） Since the primary endpoint in this study was the amount of change in ALT, elevated ALT was used as the selection criterion in the JCCLS shared reference value range so that changes could be better understood. ALT was specifically set as the upper limit of normal to 100 IU/L in the selection criteria based on the package insert of fenofibrate.
- 5） NAFLD diagnostic criteria from the 2014 NAFLD/NASH guidelines were cited. 6） NAFLD diagnostic criteria from the 2014 NAFLD/NASH guidelines were cited. 7） This was set to ensure the free and voluntary participation of the study participants.
Who cannot join
- Patients taking contraindications (see \"6.5.2.2 Contraindicated treatments\").
- Cyclosporine, rifampicin, steroids (excluding topical and inhaled drugs), amiodarone, breast cancer drugs (tamoxifen, toremifene, raloxifene).
- Patients with BMI \<18.5 kg/m2 at the time of obtaining consent.
- Patients who have been diagnosed with liver cirrhosis at the time of obtaining consent.
- Patients with findings of portal hypertension (varicose veins, ascites, encephalopathy, splenomegaly) at the time of obtaining consent.
- Patients with T-Bil \> 2× the upper limit of normal within 91 days prior to obtaining consent, excluding Girbert syndrome.
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- Platelet count \<80,000/μL within 91 days prior to obtaining consent.
- Serum Cr level of 1.5 mg/dL or higher within 91 days prior to obtaining consent.
- Patients with gallstones or biliary obstruction at the time of obtaining consent.
- Patients with severe infection, pre- or post-operative, or severe trauma at the time of obtaining consent.
- Patients who have used fibrates within 91 days prior to obtaining consent
- Patients with 10% weight change in 91 days prior to obtaining consent
- Patients who have undergone bariatric surgery or are scheduled for surgery during the study period
- Patients with a history of type I diabetes mellitus
- Patients with HbA1c \>9.5% within 91 days prior to obtaining consent (If HbA1c \>9.5%, re-entry will be possible after improvement by treatment.)
- Patients with psychosis, alcoholism, drug addiction, or narcotic addiction that would affect compliance with the research protocol
- Patients who participated in other clinical trials in 100 days prior to obtaining consent
- Pregnant women or patients who may be pregnant
- Patients with complications of malignant tumors However, patients who have undergone radical surgery or completed anticancer drug administration may enroll. Patients under observation and evaluation for malignant tumors are excluded.
- Other patients who are judged by the investigator to be inappropriate as participants of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pemafibrate for Treating NAFLD Complicated by Hypertriglyceridemia: A Multi-center, Open Study, Randomized Controlled Trial (PRESENT Study)
This is a study to evaluate the effect of pemafibrate on fatty liver in patients with hypertgemia combined with NAFLD, using fenofibrate as a control.
- Conditions
- Non Alcoholic Fatty Liver Disease
- Being tested
- Pemafibrate high dose, Pemafibrate low dose, Fenofibrate
- Keywords
- Pemafibrate, Fenofibrate
- 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.
Pemafibrate high doseDrug
Pemafibrate 0.1 mg tablets shall be administered orally twice daily, two tablets per dose, after the morning and evening meals. If unavoidable, pemafibrate extended-release 0.2 mg for 2 tablets 1 or 0.4 mg for 1 tablet 1 can be substituted.
Pemafibrate low doseDrug
Pemafibrate 0.1 mg tablets shall be administered orally twice daily, one tablet per dose, after the morning and evening meals. If unavoidable, pemafibrate extended-release 0.2 mg for 1 tablets 1 can be substituted.
FenofibrateDrug
Fenofibrate 53.3 mg tablets shall be administered orally once daily, one tablet per dose, after breakfast. Thereafter, the dose may be carefully increased to two tablets per dose at the physician\'s discretion.
| Study group | Role | What they receive |
|---|---|---|
| Pemafibrate high dose group | Experimental | Not described Receives: Drug: Pemafibrate high dose |
| Pemafibrate low dose group | Experimental | Not described Receives: Drug: Pemafibrate low dose |
| Fenofibrate group | Experimental | Not described Receives: Drug: Fenofibrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ALT level
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start23 Dec 2020
- Primary completionJun 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Multicenter, open-label, three-arm, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yokohama City University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hidenori Ohkubo, Yokohama City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623539
- Sponsor's protocol ID
- jRCTs031200280
- Status last verified
- Sep 2024
- First submitted
- 30 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pemafibrate for Treating NAFLD Complicated by Hypertriglyceridemia: A Multi-center, Open Study, Randomized Controlled Trial (PRESENT Study)
- ClinicalTrials.gov ID
- NCT06623539
- Acronym / sponsor ID
- jRCTs031200280
- Conditions
- Non Alcoholic Fatty Liver Disease
- Keywords
- Pemafibrate, Fenofibrate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Yokohama City UniversityUniversity, hospital or other
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to evaluate the effect of pemafibrate on fatty liver in patients with hypertgemia combined with NAFLD, using fenofibrate as a control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Multicenter, open-label, three-arm, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Pemafibrate high dose group | Experimental | Drug: Pemafibrate high dose |
| Pemafibrate low dose group | Experimental | Drug: Pemafibrate low dose |
| Fenofibrate group | Experimental | Drug: Fenofibrate |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Men and women at least 20 years old and under 80 years old at the time of obtaining consent.
- Patients with fatty liver diagnosed histologically within 1 year prior to obtaining consent or imaging examination within 6 months prior to obtaining consent and who have failed exercise and diet therapy for at least 3 months.
- Patients with hypertriglyceridemia (150-500 mg/dl) within 91 days prior to obtaining consent.
- Patients with elevated ALT (43-100 IU/L for men, 24-100 IU/L for women) within 91 days prior to obtaining consent.
- Patients whose daily alcohol consumption (ethanol equivalent) is less than 30 grams per day for men and less than 20 grams per day for women at the time of obtaining consent.
Key exclusion criteria (20 listed)
- Patients taking contraindications (see \"6.5.2.2 Contraindicated treatments\").
- Cyclosporine, rifampicin, steroids (excluding topical and inhaled drugs), amiodarone, breast cancer drugs (tamoxifen, toremifene, raloxifene).
- Patients with BMI \<18.5 kg/m2 at the time of obtaining consent.
- Patients who have been diagnosed with liver cirrhosis at the time of obtaining consent.
- Patients with findings of portal hypertension (varicose veins, ascites, encephalopathy, splenomegaly) at the time of obtaining consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pemafibrate high dosePemafibrate 0.1 mg tablets shall be administered orally twice daily, two tablets per dose, after the morning and evening meals. If unavoidable, pemafibrate extended-release 0.2 mg for 2 tablets 1 or 0.4 mg for 1 tablet 1 can be substituted. | Drug | Pemafibrate high dose group |
| Pemafibrate low dosePemafibrate 0.1 mg tablets shall be administered orally twice daily, one tablet per dose, after the morning and evening meals. If unavoidable, pemafibrate extended-release 0.2 mg for 1 tablets 1 can be substituted. | Drug | Pemafibrate low dose group |
| FenofibrateFenofibrate 53.3 mg tablets shall be administered orally once daily, one tablet per dose, after breakfast. Thereafter, the dose may be carefully increased to two tablets per dose at the physician\'s discretion. | Drug | Fenofibrate group |
Primary outcome
Change in ALT level
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemafibrate high dose, Pemafibrate low dose and Fenofibrate in people with Non Alcoholic Fatty Liver Disease, run by Yokohama City University at 1 site 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 13 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
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?
Change in ALT level (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2024.