UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061542 |
|---|---|
| Receipt number | R000070424 |
| Scientific Title | Retrospective observational study evaluating the efficacy and safety of pemafibrate extended-release formulation in patients with dyslipidemia |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/12 23:57:45 |
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Basic information
Public title
Retrospective observational study evaluating the efficacy and safety of pemafibrate extended-release formulation in patients with dyslipidemia
Acronym
PEMA-XR Study
Scientific Title
Retrospective observational study evaluating the efficacy and safety of pemafibrate extended-release formulation in patients with dyslipidemia
Scientific Title:Acronym
PEMA-XR Study
Region
| Japan |
Condition
Condition
Dyslipidemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively evaluate the effects of pemafibrate extended-release formulation on lipid profiles, hepatic function, renal function, body composition, liver stiffness parameters, and safety in patients with dyslipidemia treated in routine clinical practice.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in serum triglyceride levels at 6 and 12 months after initiation of pemafibrate extended-release formulation
Key secondary outcomes
Changes in HDL-C, LDL-C, AST, ALT, GGT, ALP, HbA1c, eGFR, uric acid, FIB-4 index, BMI, body composition parameters, attenuation imaging (ATI), shear wave elastography (SWE), and 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients with dyslipidemia treated at our institution
Patients who initiated or switched to pemafibrate extended-release formulation
Patients with available follow-up data for at least 12 months
Key exclusion criteria
Patients referred to another hospital during the follow-up period
Patients who discontinued or self-discontinued pemafibrate extended-release formulation
Patients who underwent surgery, chemotherapy, radiotherapy, or immunotherapy for malignancy during the study period
Patients with primary lipid disorders
Patients with insufficient data required for analysis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Saori |
| Middle name | |
| Last name | Inoue |
Organization
Meitetsu hospital
Division name
Department of Endocrinology and Metabolism
Zip code
4510052
Address
2-26-11 Sako, Nishi-ku, Nagoya, Aichi, Japan
TEL
0570023100
saori7174914@gmail.com
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Inoue |
Organization
Meitetsu Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
4510052
Address
2-26-11 Sako, Nishi-ku, Nagoya, Aichi, Japan
TEL
0570023100
Homepage URL
saori7174914@gmail.com
Sponsor or person
Institute
Meitetsu hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Meitetsu Hospital
Address
2-26-11 Sako, Nishi-ku, Nagoya, Aichi, Japan
Tel
0570023100
jimubu_uketuke@meitetsu-hpt.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
318
Org. issuing International ID_1
Institutional Review Board, Meitetsu Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
名鉄病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 01 | 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
115
Results
A total of 115 patients were included in the analysis. Serum triglyceride levels significantly decreased from 226 [142.5-368] mg/dL at baseline to 157 [119-218] mg/dL at 6 months and 148 [112-203.5] mg/dL at 12 months (both p < 0.001). Significant improvements were also observed in ALT, AST, GGT, and ALP levels. In contrast, no significant changes were observed in HbA1c, eGFR, BMI, or FIB4 index. No major safety signals were identified.
Results date posted
| 2026 | Year | 05 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 115 patients were included in the analysis, including 75 men and 40 women. The median age was 63 [52-76] years and the median BMI was 25.5 [23.3-28.8] kg/m2. The median HbA1c level was 6.5 [6.0-7.2] %, and the median triglyceride level was 226 [142.5-368] mg/dL. Diabetes mellitus was present in 82 patients, hypertension in 71 patients, and hyper-LDL cholesterolemia in 75 patients.
Participant flow
A total of 135 patients treated with pemafibrate extended-release formulation in the outpatient clinic were screened. Six patients referred to another hospital, eight patients who discontinued treatment, one death, three self-discontinuations, two patients who underwent treatment for malignancy during the study period, and one patient with a primary lipid disorder were excluded. Finally, 115 patients with at least 12 months of follow-up were included in the analysis.
Adverse events
No major drug-related adverse events were identified. Reasons for treatment discontinuation included addition of statin therapy (n=2), decline in activities of daily living (n=2), patient preference (n=1), heartburn (n=1), choledocholithiasis (n=1), and dark urine (n=1). Hospitalization events during the observation period included arteriosclerosis obliterans, tonsillitis, myocardial infarction, cellulitis, diabetes-related admission, chronic colitis, appetite loss, gastrointestinal bleeding, thoracic spinal tumor, sensorineural hearing loss, calculous pyelonephritis, cerebral infarction, choledocholithiasis, dementia, colon cancer, and pancreatitis.
Outcome measures
The primary outcome was the change in serum triglyceride levels at 12 months after initiation of pemafibrate extended-release formulation. Secondary outcomes included changes in HDL-C, LDL-C, AST, ALT, GGT, ALP, HbA1c, eGFR, uric acid, FIB-4 index, BMI, body composition, attenuation imaging (ATI), shear wave elastography (SWE), and adverse events.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2026 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2026 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2026 | Year | 05 | Month | 01 | Day |
Other
Other related information
This study was a single-center retrospective observational study. Clinical and laboratory data were retrospectively collected from electronic medical records of patients with dyslipidemia treated with pemafibrate extended-release formulation in routine clinical practice.
Management information
Registered date
| 2026 | Year | 05 | Month | 13 | Day |
Last modified on
| 2026 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070424
