UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061398 |
|---|---|
| Receipt number | R000070251 |
| Scientific Title | A Retrospective Study of the Effects of Pemafibrate in Patients with Dyslipidemia Complicated by Metabolic Dysfunction-Associated Steatotic Liver Disease |
| Date of disclosure of the study information | 2026/04/28 |
| Last modified on | 2026/04/28 11:42:04 |
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Basic information
Public title
A Retrospective Study of the Effects of Pemafibrate in Patients with Dyslipidemia Complicated by Metabolic Dysfunction-Associated Steatotic Liver Disease
Acronym
Effects of Pemafibrate in Patients with Dyslipidemia and MASLD
Scientific Title
A Retrospective Study of the Effects of Pemafibrate in Patients with Dyslipidemia Complicated by Metabolic Dysfunction-Associated Steatotic Liver Disease
Scientific Title:Acronym
A Retrospective Observational Study Investigating the Effects of Pemafibrate in Patients with Dyslipidemia Complicated by Metabolic Dysfunction-Associated Steatotic Liver Disease
Region
| Japan |
Condition
Condition
Patients with dyslipidemia complicated by steatotic liver disease/MASLD
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to assess the clinical course following pemafibrate administration in patients with dyslipidemia complicated by MASLD who are regularly followed at our hospital, with comparisons according to the presence or absence of impaired glucose tolerance, and to evaluate the effects of pemafibrate on glucose metabolism and MASLD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in FAST score by impaired glucose tolerance status
Key secondary outcomes
Vibration-controlled transient elastography, controlled attenuation parameter, and FAST score measured using FibroScan; lipid parameters, including triglycerides, total cholesterol, HDL cholesterol, and LDL cholesterol; glucose metabolism-related parameters, including blood glucose and HbA1c; fatty liver/MASLD-related parameters, including body weight, AST, ALT, G-GTP, ALP, total bilirubin, albumin, prothrombin time, platelet count, FIB-4 index, and APRI; and renal function-related parameters, including BUN, creatinine, and eGFR.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with dyslipidemia complicated by fatty liver disease/MASLD who attended the participating medical institution during the study period, received pemafibrate, and for whom the presence or absence of impaired glucose tolerance can be confirmed.
Patients whose required data items, as described below, are recorded in the electronic medical records.
Key exclusion criteria
Patients for whom the required data items cannot be collected from the medical records.
Target sample size
495
Research contact person
Name of lead principal investigator
| 1st name | Kensaku |
| Middle name | |
| Last name | Fukunaga |
Organization
Kagawa University Hospital, Faculty of Medicine
Division name
Department of Endocrinology and Metabolism, Faculty of Medicine
Zip code
761-0793
Address
1750-1, Ikenobe, Miki-cho, Kita-gun
TEL
0878912230
fukunaga.kensaku@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | kensaku |
| Middle name | |
| Last name | fukunaga |
Organization
Kagawa university
Division name
Department of Endocrinology and Metabolism
Zip code
761-0793
Address
1750-1, Ikenobe, Miki-cho, Kita-gun
TEL
0878912230
Homepage URL
fukunaga.kensaku@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa university
Institute
Department
Personal name
Fukunaga
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Faculty of Medicine, Kagawa University
Address
1750-1, Miki-cho
Tel
0878985111
chiken-m@kagawa-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
--- Select One ---
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 28 | 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
495
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with dyslipidemia complicated by MASLD who visited our hospital or the participating medical institutions that provide existing information only between October 1, 2018 and October 31, 2023.
Management information
Registered date
| 2026 | Year | 04 | Month | 28 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070251
