UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063510 |
|---|---|
| Receipt number | R000071162 |
| Scientific Title | Association between selectibe PPARα modulator use and changes in liver function in patients with non-obese metabolic dysfunction-associated steatotic liver disease (MASLD) with dyslipidemia: a prospective observational study |
| Date of disclosure of the study information | 2026/11/05 |
| Last modified on | 2026/11/04 15:45:20 |
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Basic information
Public title
A prospective observational study to investigate the effects of pemafinrate on liver function in patients with non-obese Steatotic liver disease and dyslipidemia.
Acronym
PRISMA study
Scientific Title
Association between selectibe PPARα modulator use and changes in liver function in patients with non-obese metabolic dysfunction-associated steatotic liver disease (MASLD) with dyslipidemia: a prospective observational study
Scientific Title:Acronym
PRISMA study (PemafibRate Investigation in non-obese Steatotic liver disease with Metabolic Abnormalities)
Region
| Japan |
Condition
Condition
Non- obese metabolic dysfunciton-associated steatotic liver disease(MASLD) with dyslipidemia
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of pemafibrate, a selective PPAR alpha modulator, on liver function in patients with non-obese MASLD and dyslipidemia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in ALT from baseline to Week 52 after treatment initiation
Key secondary outcomes
Changes from baseline to 24 weeks in: lipids (TG, HDL-C, TC, LDL-C), glycemic parameters (HbA1c, fasting plasma glucose, fasting insulin, HOMA-IR), liver function (ALT, AST, gamma-GTP, platelet count), urinary protein (protein, albumin), liver fibrosis markers (FIB-4 index, APRI, M2BPGi,) body weight, BMI, body composition (skeletal muscle mass, body fat mass, body fat percentage, SMI, basal metabolic rate), and grip strength
Changes from baseline to Week 52 in: lipids (TG, HDL-C, TC, LDL-C), glycemic parameters (HbA1c, fasting plasma glucose, fasting insulin, HOMA-IR), liver function (ALT, AST, gamma-GTP, platelet count), urinary protein (protein, albumin), liver fibrosis markers (FIB-4 index, APRI, M2BPGi,) body weight, BMI, body composition (skeletal muscle mass, body fat mass, body fat percentage, SMI, basal metabolic rate), and grip strength
Adverse events and side effects.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Male or female patients aged 18 years or older who have been diagnosed with dyslipidemia and MASLD before informed consent
2. BMI <25 kg/m2
3. Patients judged by the physician to require pemafibrate treatment
4. Patients who provide written informed consent to participate in this study.
Key exclusion criteria
1. Use of pemafibrate or other fibrates within 3 months before consent
2. Dose changes within 3 months before consent in glucocorticoids, thiazolidinediones, SGLT2 inhibitors, GLP-1 receptor agonists, or GLP-1/GIP receptor agonists
3. Planned dose changes at the time of consent in glucocorticoids, thiazolidinediones, SGLT2 inhibitors, GLP-1 receptor agonists, or GLP-1/GIP receptor agonists
4. Severe renal dysfunction (eGFR <30 mL/min/1.73 m2)
5. Severe anemia (Hb <10 g/dL)
6. Contraindications to pemafibrate.
7. Patients considered inappropriate for inclusion by the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takehiro |
| Middle name | |
| Last name | Kato |
Organization
Gifu University Hospital
Division name
Division of Diabetes, Metabolism and Endocrinology
Zip code
501-1194
Address
1-1, Yanagido, Gifu, Japan
TEL
0572306377
kato.takehiro.v6@f.gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Takahashi |
Organization
Gifu University Hospital
Division name
Division of Diabetes, Metabolism and Endocrinology
Zip code
501-1194
Address
1-1, Yanagido, Gifu, Japan
TEL
0572306377
Homepage URL
takahashi.yoshihiro.r9@f.gifu-u.ac.jp
Sponsor or person
Institute
Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kowa Company. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of the Graduate School of Medicine, Gifu University
Address
1-1 Yanagido, GIfu City, Gifu
Tel
0572306059
rinri@t.gifu-u.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
岐阜大学医学部附属病院/Gifu University Hospital
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study involving patients with dyslipidemia and non-obese metabolic dysfunction-associated steatotic liver disease (MASLD). Patients for whom the attending physician determines that pemafibrate treatment is indicated under routine clinical practice will be eligible for inclusion. Participants will freely choose whether to receive pemafibrate (pemafibrate group) or not (non-treatment group). Changes in liver function will be compared between the two groups at baseline and at 24 and 52 weeks after the start of observation.
The primary endpoint is the change in alanine aminotransferase (ALT) levels from baseline to week 52. Secondary endpoints include longitudinal changes in lipid metabolism, glucose metabolism, liver fibrosis markers, and body composition.
Management information
Registered date
| 2026 | Year | 11 | Month | 04 | Day |
Last modified on
| 2026 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071162
