NCT02068339

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
283

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

2 years

First QC Date

February 19, 2014

Last Update Submit

March 29, 2016

Conditions

Non-alcholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

  • MRS(magnetic resonance spectroscopy)

    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.

    24 weeks

Secondary Outcomes (7)

  • change in liver fat concentration

    24 weeks

  • change in BMI

    8, 16, 24 weeks

  • change in NAFLD Fibrosis score (NFS)

    24 weeks

  • change in ALT, AST, γ-GT

    8, 16, 24 weeks

  • change in Cholesterol (total, LDL, HDL, VLDL), Triglyceride (TG)

    8, 16, 24 weeks

  • +2 more secondary outcomes

Other Outcomes (1)

  • change in Adipokine, CK-18

    8, 16, 24 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo Comparator / Tid (total 0mg)

Drug: Placebo

Oltipraz 1

EXPERIMENTAL

Total 90mg, by mouth, tid

Drug: Oltipraz 1 (90mg)

Oltipraz 2

EXPERIMENTAL

Total 120mg, by mouth, tid

Drug: Oltipraz 2 (120mg)

Interventions

Oltipraz 1 (90mg)DRUG
Oltipraz 1
PlaceboDRUG
Placebo
Oltipraz 2 (120mg)DRUG
Oltipraz 2

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 (+)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

NHUS Ilsan Hospital

Ilsan-ro Ilsan-donggu, Goyang-si, 410-719, South Korea

Location

Inje University Ilsan Paik Hospital

Dahwa-dong, Ilsanseo-gu, Goyang-si, Gyeonggi-do, 411-706, South Korea

Location

Seoul National University Hospital

Daehak-ro Jongno-gu, Seoul, 110-744, South Korea

Location

Korea University Guro hospital

Gurodong-ro, Seoul, 152-703, South Korea

Location

Boramae Hospital

Sindaebang-dong Dongjak-gu, Seoul, 156-707, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 21, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

March 30, 2016

Record last verified: 2016-03

Locations

KR(5)