The primary objective of the study is to compare the changes in ALT to baseline among patients with non-alcoholic fatty liver disease (NAFLD) following the 3-month treatment of 3 different dosing regimens of SNP-612. The secondary objectives will be to compare the changes in other liver function tests, cytokeratin-18 (CK-18) fragment level and adverse event / serious adverse event rates.
An open-label study will be conducted in medical centers around Taiwan. The objective of the study is to investigate the efficacy and safety of SNP-612 for the treatment of NAFLD. Subjects who fulfill all the entry criteria and have written informed consent will be enrolled to the study. Considering a 10% drop-out rate, approximately 72 subjects will be enrolled in order to recruit 64 evaluable subject subjects to complete the enrollment. Subjects will be administered the study agents oral daily for 3 months or until treatment terminates prematurely. Subjects will return to the study center for clinical evaluation once every 4 weeks throughout the treatment period. Clinical assessment procedures and laboratory tests including ultrasound imaging, hematology with differential, biochemistry, liver function panel, and urinalysis, will be performed at each study visit. The primary endpoint assessment will be the reduction of ALT, at completion of Week 12 compared to baseline. With 64 evaluable patients, there will be an 80% chance of detecting a significant difference at a two sided 0.05 significance level. Subjects who finish treatment or discontinue prematurely from the study for any reason after receiving one or more doses of study agent will be assessed for safety for 2 (±1) weeks after the last study agent dose or longer in the case of any significant AE or abnormal biochemical or clinical finding. Each subject will participate in the study for approximately 14 weeks (including the enrollment/baseline visit, 3 routine monthly visits during treatment period, and 1 follow-up visit after 2 weeks of the end of treatment). It is assumed the study will include a 6 months enrollment period and a further 4 months to complete the follow-up for all enrolled patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Subjects will take dose1 once a day orally for 12 weeks
Subjects will take dose2 once a day orally for 12 weeks
Tri-Service General Hospital
Taipei, Taiwan
Change in serum ALT
A reduction from baseline (i.e. a negative percent value) indicates an improvement in condition
Time frame: 12 weeks
Change in serum AST
A reduction from baseline (i.e. a negative percent value) indicates an improvement in condition
Time frame: 12 weeks
Change in serum Alk-P
A reduction from baseline (i.e. a negative percent value) indicates an improvement in condition
Time frame: 12 weeks
Change in serum γ-GT
A reduction from baseline (i.e. a negative percent value) indicates an improvement in condition
Time frame: 12 weeks
Change in GSP
A reduction from baseline (i.e. a negative percent value) indicates an improvement in condition
Time frame: 12 weeks
Change in liver fat content as measured by liver fat fraction (FF) with magnetic resonance imaging method.
A non-invasive method will be utilized to estimate liver fat content (%) by MRI calculated liver FF.
Time frame: 12 weeks
Change in serum CK-18 fragment levels
A reduction from baseline (i.e. a negative percent value) indicates an improvement in condition
Time frame: 12 weeks
Rate of AE/SAE
Rate of patients who experience AE/SAE at end of treatment
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Time frame: 12 weeks
Rate of AEs leading to discontinuation at end of treatment
Rate of patients who experience AEs leading to discontinuation at end of treatment
Time frame: 12 weeks