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Therapeutic Exploratory Phase 2 Study to Evaluate the Safety and Efficacy of MB12066 in Patients With Nonalcoholic Fatty Liver Disease(NAFLD) Except Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02029586
Recruitment Status : Terminated (Lack of recruitment)
First Posted : January 8, 2014
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Yungjin Pharm. Co., Ltd.

Brief Summary:
This is a controlled study to determine the effectiveness and safety of MB12066 in the treatment of adult patients with Nonalcoholic Fatty Liver Disease(NAFLD) except cirrhosis.

Condition or disease Intervention/treatment Phase
Nonalcoholic Fatty Liver Disease Drug: MB12066 200mg Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, 12 Weeks, Therapeutic Exploratory Phase 2 Clinical Study to Evaluate the Safety and Efficacy of MB12066 in Patients With Nonalcoholic Fatty Liver Disease (NAFLD) Except Cirrhosis
Study Start Date : January 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014


Arm Intervention/treatment
Experimental: MB12066 Drug: MB12066 200mg
oral administration, 100mg bid

Placebo Comparator: Placebo Drug: Placebo
oral administration, 100mg bid




Primary Outcome Measures :
  1. Change in hepatic steatosis(%) [ Time Frame: baseline, 12 weeks ]
    The NAFLD Activity Score (NAS) grades NAFLD on liver biopsy based on the individual scoring of steatosis, inflammation and ballooning. The NAS is assessed on a scale of 0 to 8 with higher scores indicating more severe disease and lower scores indicating less severe disease. NAS is obtained by adding steatosis(assessed on a scale of 0 to 3), inflammation (assessed on a scale of 0 to 3) and ballooning (assessed on a scale of 0 to 2).


Secondary Outcome Measures :
  1. Proportion of subjects with more than 1 point in total NAFLD Activity Score (NAS) [ Time Frame: baseline, 12 weeks ]
  2. Change in fibrosis score [ Time Frame: baseline, 12 weeks ]
  3. Change in steatosis score [ Time Frame: baseline, 12weeks ]
  4. Change in lobular inflammation score [ Time Frame: baseline, 12weeks ]
  5. Change in ballooning score [ Time Frame: baseline, 12weeks ]
  6. Change in lipid profile [ Time Frame: baseline, 4weeks, 8weeks, 12weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • NAFLD Activity Score(NAS) ≥ 3 (Biopsy-proven)

Exclusion Criteria:

  • Alcohol consumption > 20g/day
  • Type 1 diabetes or poorly controlled diabetes mellitus (HbA1c ≥ 9%)
  • Evidence of other chronic liver disease (e.g. HBsAg positive, anti-HCV positive, autoimmune hepatitis, Wilson's disease, alpha-1 antitrypsin deficiency and etc.)
  • ALT, AST > 5X the upper limit of normal
  • Serum creatinine ≥ 2mg/dl
  • Fibrosis score ≥ 3 according to the NASH CRN fibrosis staging system
  • NQO1 T/T type
  • Weight loss of more than 5kg within 6 months
  • Bariatric surgery within 6 months
  • Known alcohol or any other drug abuse in the last five years
  • Insulin sensitizers, hepatoprotective agents, anti-oxidants, lipid-lowering agents, drugs induced fatty liver within 1 month

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): NCT02029586


Locations
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Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Banpo-daero Seocho-gu, Korea, Republic of, 137-701
Uijeongbu St. Mary's Hospital
Uijeongbu, Cheonbo-ro Gyeonggi-do, Korea, Republic of, 480-710
Seoul National University Hospital
Seoul, Daehak-ro Jongno-gu, Korea, Republic of, 110-744
Keimyung University Donsan Medical Center
Daegu, Dalseong-ro Jung-gu, Korea, Republic of, 700-712
Kyungpook National University Hospital
Daegu, Dongdeok-ro Jung-gu, Korea, Republic of, 700-721
Chung-ang University Hospital
Seoul, Heukseok-dong Dongjak-gu, Korea, Republic of, 156-755
ASAN Medical Center
Seoul, Olympic-ro 43-gil, Songpa-gu, Korea, Republic of, 138-736
Boramae Hospital
Seoul, Sindaebang-dong Dongjak-gu, Korea, Republic of, 156-707
Hanyang University Medical Center
Seoul, Wangsimni-ro Seongdong-gu, Korea, Republic of, 133-792
Severance Hospital
Seoul, Yonsei-ro Seodaemun-gu, Korea, Republic of, 120-752
Sponsors and Collaborators
Yungjin Pharm. Co., Ltd.
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Responsible Party: Yungjin Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT02029586    
Other Study ID Numbers: MB12066_201
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Beta-lapachone
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents