UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056083 |
|---|---|
| Receipt number | R000064072 |
| Scientific Title | Effect of pemafibrate on liver fibrosis in MetALD with hypertriglyceridemia (PELMET) |
| Date of disclosure of the study information | 2024/11/10 |
| Last modified on | 2024/11/07 10:02:43 |
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Basic information
Public title
Effect of pemafibrate on liver fibrosis in MetALD with hypertriglyceridemia (PELMET)
Acronym
PELMET study
Scientific Title
Effect of pemafibrate on liver fibrosis in MetALD with hypertriglyceridemia (PELMET)
Scientific Title:Acronym
PELMET study
Region
| Japan |
Condition
Condition
MetALD complicated with dyslipidemia
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to clarify the effect of pemafibrate on improving steatohepatitis and fibrosis using MRE and MR fingerprinting in patients with MetALD complicated by dyslipidemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Liver fibrosis and liver lipid content after 48 weeks of pemafibrate administration.
Key secondary outcomes
Blood tests, serum fibrosis markers, fatty acid fractionation, and body composition analysis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients will be administered 0.2 mg or 0.4 mg of pemafibrate (Palmodia XR) for 48 weeks, and will be evaluated every 8 weeks through medical examinations and blood sampling. Evaluation of liver fibrosis (MRE, MRI-T1 mapping, MR fingerprinting, FibroScan), evaluation of liver inflammation (MRI-T1/T2 mapping, MR fingerprinting), measurement of liver lipid content (MRI-PDFF, MR fingerprinting, FibroScan)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age 18 or over at the point of obtaining consent.
Those who have been diagnosed with hepatic steatosis by either diagnostic imaging or liver biopsy, and who fulfill at least one of the following five criteria (BMI>23 or waist circumference (men > 94 cm, women > 80 cm), Fasting blood glucose>100 mg/dL or 2-hour post-load blood glucose >140 mg/dL or HbA1c >5.7% or diagnosed or being treated for type 2 diabetes. Blood pressure >130/85 mmHg or being treated with medication for hypertension. TG >150 mg/dL or being treated for dyslipidemia. HDL-C is <40 mg/dL in men and <50 mg/dL in women, or you are being treated for dyslipidemia.
Those who have a habit of consuming alcohol (alcohol consumption of 210 g or more but less than 420 g of ethanol per week for men, and 140 g or more but less than 350 g of ethanol per week for women) at the time of obtaining consent
The diagnosis of hyperlipidemia is based on the 2022 edition of the guidelines for the prevention of arteriosclerotic diseases (fasting serum TG of 150 mg/dL or more, or random serum TG of 175 mg/dL or more)
After receiving sufficient explanation regarding participation in this study, the research subject has provided written consent of their own free will with a full understanding of the study.
Key exclusion criteria
Patients with a FIB-4 index of less than 1.3 within 10 weeks prior to obtaining consent
Patients with fatty liver caused by medication or Wilson's disease (specific aetiology SLD)
Patients who fall under the contraindications for pemafibrate (patients with a history of hypersensitivity to the ingredients, patients with severe liver damage, patients with cirrhosis classified as Child-Pugh B or C, patients with biliary obstruction, patients with gallstones, pregnant women or women who may be pregnant, patients receiving cyclosporine or rifampicin)
Patients undergoing treatment for malignant diseases, including liver cancer
Patients who have received treatment with fibrates or selective PPAR modulators within 12 weeks of obtaining consent
Other patients deemed unsuitable as research subjects by the principal investigator or sub-investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Uchiyama |
Organization
Juntendo University School of Medicine
Division name
Gastroenterology
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421 Japan
TEL
03-3813-3111
auchiya@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Uchiyama |
Organization
Juntendo University School of Medicine
Division name
Gastroenterology
Zip code
1138421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421 Japan
TEL
0338133111
Homepage URL
auchiya@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kowa company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo Clinical Research and Trial center
Address
Clinical Research and Trial Center,Juntendo University Hospital 3-1-3,Hongo,Bunkyo-ku,Tokyo 113-8431,Japan
Tel
03-3814-5672
jcrtc_operation@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 07 | Day |
Last modified on
| 2024 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064072
