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Trial record 30 of 346 for:    hepatic steatosis AND fat AND Nonalcoholic Fatty Liver

Efficacy and Safety of Oltipraz for Liver Fat Reduction in Patients With Non-Alcoholic Fatty Liver Disease Except for Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT02068339
Recruitment Status : Completed
First Posted : February 21, 2014
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
PharmaKing

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-alcholic Fatty Liver Disease Drug: Oltipraz 1 (90mg) Drug: Placebo Drug: Oltipraz 2 (120mg) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 283 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo Comparator / Tid (total 0mg)
Drug: Placebo
Experimental: Oltipraz 1
Total 90mg, by mouth, tid
Drug: Oltipraz 1 (90mg)
Experimental: Oltipraz 2
Total 120mg, by mouth, tid
Drug: Oltipraz 2 (120mg)



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. change in liver fat concentration [ Time Frame: 24 weeks ]
  2. change in BMI [ Time Frame: 8, 16, 24 weeks ]
  3. change in NAFLD Fibrosis score (NFS) [ Time Frame: 24 weeks ]
  4. change in ALT, AST, γ-GT [ Time Frame: 8, 16, 24 weeks ]
  5. change in Cholesterol (total, LDL, HDL, VLDL), Triglyceride (TG) [ Time Frame: 8, 16, 24 weeks ]
  6. change in HOMA-IR [ Time Frame: 8, 16, 24 weeks ]
  7. change in waist circumference [ Time Frame: 24 weeks ]

Other Outcome Measures:
  1. change in Adipokine, CK-18 [ Time Frame: 8, 16, 24 weeks ]


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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068339


Locations
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Korea, Republic of
NHUS Ilsan Hospital
Ilsan-ro Ilsan-donggu, Goyang-si, Korea, Republic of, 410-719
Inje University Ilsan Paik Hospital
Dahwa-dong, Ilsanseo-gu, Goyang-si, Gyeonggi-do, Korea, Republic of, 411-706
Seoul National University Hospital
Daehak-ro Jongno-gu, Seoul, Korea, Republic of, 110-744
Korea University Guro hospital
Gurodong-ro, Seoul, Korea, Republic of, 152-703
Boramae Hospital
Sindaebang-dong Dongjak-gu, Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
PharmaKing

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Responsible Party: PharmaKing
ClinicalTrials.gov Identifier: NCT02068339     History of Changes
Other Study ID Numbers: PMK-N01GI1_Phase 3
First Posted: February 21, 2014    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Liver Cirrhosis
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Oltipraz
Antiviral Agents
Anti-Infective Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents