UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of pemafibrate (Parmodia) for patients having dyslipidemia and non-alcoholic fatty liver disease (NAFLD)
Title of the study (Brief title)	Safety and efficacy of pemafibrate (Parmodia) for patients having dyslipidemia and non-alcoholic fatty liver disease (NAFLD)
Region	Japan

Condition
Condition	Patients with dyslipidemia and non-alcoholic fatty liver disease (NAFLD)
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of pemafibrate for NAFLD
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in liver enzymes at 24 and 48 weeeks after commencing the treatment
Key secondary outcomes	Changes in liver fat/visceral fat calculated by CT and blood lipid, glucose, inflammation markers

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	pemafibrate 0.1mg x2/day, max 0.2mg x2/day, 48 weeks.
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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Fasting triglyceride > 150 mg/dL, or LDL-C > 140 mg/dL, or HDL-C < 40mg/dL. 2. NAFLD with ALT > 40 U/L 3. Good activity of daily life and NO serious diseases 4. NO renal dysfunction 5. Agreement not to change daily activity and medications markedly 6. Agreement to undergo regular examination and medications 7. Agreement to participate in this trial by oneself
Key exclusion criteria	1. Creatinine > 1.5 mg/dL 2. Past history of myopathy and renal dysfunction by fibrate drugs 3. During Pregnancy and breast-feeding 4. Humans who were judged as not-suitable for this trial
Target sample size	20

Research contact person
Name of lead principal investigator	Naoki Tanaka
Organization	Shinshu University School of Medicine
Division name	Department of Metabolic Regulation
Address	Asahi 3-1-1, Matsumoto, Nagano
TEL	0263-37-2851
Email	naopi@shinshu-u.ac.jp

Public contact
Name of contact person	Naoki Tanaka
Organization	Shinshu University School of Medicine
Division name	Department of Metabolic Regulation
Address	Asahi 3-1-1, Matsumoto, Nagano
TEL	0263-37-2851
Homepage URL
Email	naopi@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University School of Medicine
Institute
Department

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)

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	2018 Year 12 Month 13 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 10 Month 23 Day
Anticipated trial start date	2018 Year 12 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 12 Month 13 Day
Last modified on	2018 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040162