UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060348 |
|---|---|
| Receipt number | R000066175 |
| Scientific Title | An Observational Study on the Effects of Pemafibrate on Liver Function in Patients with Metabolic Dysfunction Associated Steatotic Liver Disease and Hypertriglyceridemia |
| Date of disclosure of the study information | 2026/01/14 |
| Last modified on | 2026/01/14 12:45:41 |
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Basic information
Public title
A Study to Observe Changes in Liver Function and Gut Microbiota in Patients with Fatty Liver Disease and High Triglycerides Receiving Pemafibrate
Acronym
PEMA-GUT study
Scientific Title
An Observational Study on the Effects of Pemafibrate on Liver Function in Patients with Metabolic Dysfunction Associated Steatotic Liver Disease and Hypertriglyceridemia
Scientific Title:Acronym
PEMA-GUT Study Pemafibrate Effects on Metabolism and Gut Microbiota in MASLD
Region
| Japan |
Condition
Condition
Metabolic Dysfunction Associated Steatotic Liver Disease and Hypertriglyceridemia
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate longitudinal changes in liver function-related clinical parameters in patients with MASLD complicated by hypertriglyceridemia who are treated with pemafibrate
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percent change in serum ALT from baseline (week 0) to week 24 after initiation of pemafibrate
Key secondary outcomes
Changes in gut microbiota composition and diversity
Changes in liver function, lipid profiles, and fibrosis markers
Imaging parameters (MRI-PDFF, MRE, ultrasound)
Incidence of adverse events
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligible patients will be those who are diagnosed with fatty liver based on imaging modalities (abdominal ultrasonography or MRI-PDFF), fulfill the diagnostic criteria for MASLD, have a fasting serum triglyceride level of over 150 mg/dL, and are considered suitable for pemafibrate therapy by their physician due to inadequate response to dietary and exercise interventions. Written informed consent must be obtained prior to study participation.
Key exclusion criteria
Patients with contraindications to pemafibrate (e.g., severe hepatic impairment, biliary obstruction, pregnant or breastfeeding women).
Patients with liver diseases other than MASLD, such as viral hepatitis, autoimmune liver disease, or drug-induced liver injury.
Patients who have used medications that may affect the gut microbiota (e.g., antibiotics, probiotic supplements) within 3 months prior to study enrollment.
Patients with poorly controlled diabetes mellitus, defined as HbA1c over 8.0%.
Patients with habitual excessive alcohol consumption, defined as over 30 g/day of pure ethanol for men and over 20 g/day for women.
Any other patients deemed inappropriate for participation in the study by the attending physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Hiasa |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
7910295
Address
454 Shizugawa, Toon City, Ehime Prefecture
TEL
0899605308
3naika@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Taisei |
| Middle name | |
| Last name | Murakami |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
7910295
Address
454 Shizugawa, Toon City, Ehime Prefecture
TEL
0899605308
Homepage URL
m09103tm@jichi.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Kowa Company, Ltd
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
Institutional Review Board,Ehime University Hospital
Address
454 Shitsukawa, Toon, Ehime
Tel
0899605172
rinri@m.ehime-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
愛媛大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center, prospective, observational study without a control group.
Longitudinal changes in liver function and gut microbiota are evaluated using within-subject comparisons from baseline.
Management information
Registered date
| 2026 | Year | 01 | Month | 14 | Day |
Last modified on
| 2026 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066175
