NCT Number: NCT02068339
Efficacy and Safety of Oltipraz for Liver Fat Reduction in Patients With Non-Alcoholic Fatty Liver Disease Except for Liver Cirrhosis
Dithiolethiones, a novel class of adenosine monophosphate-activated protein kinase (AMPK) activators, prevent insulin resistance through AMPK-dependent p70 ribosomal S6 kinase-1 (S6K1) inhibition. And it is well known that the modulation of S6K1 by oltipraz inhibited the development of insulin resistance and hyperglycemia through the AMPK-S6K1 pathway.Also some research reported that LXRg (a member of the nuclear hormone receptor)-mediated increases in SREBP-1c (the sterol regulatory element-binding protein-1c gene) promote the expression of lipogenic genes and enhance fatty acid synthesis and oltipraz inhibits LXRg and SREBP-c. Therefore, Oltipraz inhibits fatty acid synthesis through AMPK-S6K1 pathway and LXRg-SREBP-1c pathway in liver.
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Notify MeKey information
Conditions
Age range
19 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
NHUS Ilsan Hospital, Ilsan-ro Ilsan-donggu, Goyang-si, South Korea
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients over 19 under 75 years of age
- Patients with non-alcoholic fatty liver disease except for cirrhosis
- Patients who have abnormal ALT, AST
- Patients who are satisfied with laboratory test
- Patients who agree to contraception
- Patients who can keet the diet
Exclusion criteria
- Over 2 ratio of AST to ALT
- Type 1 diabetes mellitus (insulin-dependent diabetes mellitus) or Type 2 diabetes mellitus(not controlled)
- Disorder in liver function with an exception of non-alcoholic fatty liver
- Patients with malignant tumors
- Patients who have been taken drugs induced fatty liver within 8 weeks of participation in this study
- Patients who has been taken any medications that could affect the treatment for NAFLD within 4 weeks
- Patients who have been taken Vitamin E (≥ 800 IU/day), thiazolidinediones, orlistat within 12 weeks
- Patients who had a Bariatric surgery less than 6 month prior to the participation in the study
- Patients who are judged by investigator that participation of the study is difficult due to disease as follow;
- Any history of immune disorder
- Patients who have received treatment that may affect liver function within 1 month prior to the participation in the study
- Patient who has been administered other investigational product within 1 month prior to the participation in the study
- Patient who is not allowed to get MRS test: pacemaker, shunt and etc
- Pregnant or nursing women
- anti-HIV antibody (+)
- Patient who considered ineligible for participation in the study as Investigator's judgment
Treatment and study plan
Placebo
DrugOltipraz 2 (120mg)
DrugPrimary outcomes
-
MRS(magnetic resonance spectroscopy)
Time frame: 24 weeks
To evaluate the efficacy of the Oltipraz on change in quantity of liver fat (% change) assessed by MRS from baseline to 24 weeks in patients.
Secondary outcomes
-
change in liver fat concentration
Time frame: 24 weeks
-
change in BMI
Time frame: 8, 16, 24 weeks
-
change in NAFLD Fibrosis score (NFS)
Time frame: 24 weeks
-
change in ALT, AST, γ-GT
Time frame: 8, 16, 24 weeks
-
change in Cholesterol (total, LDL, HDL, VLDL), Triglyceride (TG)
Time frame: 8, 16, 24 weeks
-
change in HOMA-IR
Time frame: 8, 16, 24 weeks
-
change in waist circumference
Time frame: 24 weeks
Other outcomes
-
change in Adipokine, CK-18
Time frame: 8, 16, 24 weeks
Sponsors and collaborators
Lead sponsor
PharmaKing
Industry
Registry information
Official study title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Oltipraz for Liver Fat Reduction in Patients With Non-Alcoholic Fatty Liver Disease Except for Liver Cirrhosis
Important dates
- Study start
- 2014
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Feb 21, 2014
- Registry last updated
- Mar 30, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.