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

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

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.

Study Overview

• Status: Terminated
• Conditions: Nonalcoholic Fatty Liver Disease
• Intervention / Treatment: Drug: MB12066 200mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Banpo-daero Seocho-gu
    • Seoul, Banpo-daero Seocho-gu, Korea, Republic of, 137-701
      • Seoul St. Mary'S Hospital
  • Cheonbo-ro Gyeonggi-do
    • Uijeongbu, Cheonbo-ro Gyeonggi-do, Korea, Republic of, 480-710
      • Uijeongbu St. Mary's Hospital
  • Daehak-ro Jongno-gu
    • Seoul, Daehak-ro Jongno-gu, Korea, Republic of, 110-744
      • Seoul National University Hospital
  • Dalseong-ro Jung-gu
    • Daegu, Dalseong-ro Jung-gu, Korea, Republic of, 700-712
      • Keimyung University Donsan Medical Center
  • Dongdeok-ro Jung-gu
    • Daegu, Dongdeok-ro Jung-gu, Korea, Republic of, 700-721
      • Kyungpook National University Hospital
  • Heukseok-dong Dongjak-gu
    • Seoul, Heukseok-dong Dongjak-gu, Korea, Republic of, 156-755
      • Chung-Ang University Hospital
  • Olympic-ro 43-gil, Songpa-gu
    • Seoul, Olympic-ro 43-gil, Songpa-gu, Korea, Republic of, 138-736
      • Asan Medical Center
  • Sindaebang-dong Dongjak-gu
    • Seoul, Sindaebang-dong Dongjak-gu, Korea, Republic of, 156-707
      • Boramae Hospital
  • Wangsimni-ro Seongdong-gu
    • Seoul, Wangsimni-ro Seongdong-gu, Korea, Republic of, 133-792
      • Hanyang University Medical Center
  • Yonsei-ro Seodaemun-gu
    • Seoul, Yonsei-ro Seodaemun-gu, Korea, Republic of, 120-752
      • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; oral administration, 100mg bid
Experimental: MB12066	Drug: MB12066 200mg; oral administration, 100mg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hepatic steatosis(%)	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).	baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with more than 1 point in total NAFLD Activity Score (NAS)	baseline, 12 weeks
Change in fibrosis score	baseline, 12 weeks
Change in steatosis score	baseline, 12weeks
Change in lobular inflammation score	baseline, 12weeks
Change in ballooning score	baseline, 12weeks
Change in lipid profile	baseline, 4weeks, 8weeks, 12weeks

Collaborators and Investigators

• Sponsor: Yungjin Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: January 6, 2014
• First Submitted That Met QC Criteria: January 6, 2014
• First Posted (Estimate): January 8, 2014

Study Record Updates

• Last Update Posted (Actual): December 21, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Beta-lapachone
• Other Study ID Numbers: MB12066_201