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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

Primary Purpose

Nonalcoholic Fatty Liver Disease

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MB12066 200mg
Placebo
Sponsored by
Yungjin Pharm. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Fatty Liver Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul St. Mary's Hospital
  • Uijeongbu St. Mary's Hospital
  • Seoul National University Hospital
  • Keimyung University Donsan Medical Center
  • Kyungpook National University Hospital
  • Chung-ang University Hospital
  • ASAN Medical Center
  • Boramae Hospital
  • Hanyang University Medical Center
  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MB12066

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Proportion of subjects with more than 1 point in total NAFLD Activity Score (NAS)
Change in fibrosis score
Change in steatosis score
Change in lobular inflammation score
Change in ballooning score
Change in lipid profile

Full Information

First Posted
January 6, 2014
Last Updated
December 19, 2017
Sponsor
Yungjin Pharm. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02029586
Brief Title
Therapeutic Exploratory Phase 2 Study to Evaluate the Safety and Efficacy of MB12066 in Patients With Nonalcoholic Fatty Liver Disease(NAFLD) Except Cirrhosis
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 Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yungjin Pharm. Co., Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MB12066
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MB12066 200mg
Intervention Description
oral administration, 100mg bid
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral administration, 100mg bid
Primary Outcome Measure Information:
Title
Change in hepatic steatosis(%)
Description
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).
Time Frame
baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects with more than 1 point in total NAFLD Activity Score (NAS)
Time Frame
baseline, 12 weeks
Title
Change in fibrosis score
Time Frame
baseline, 12 weeks
Title
Change in steatosis score
Time Frame
baseline, 12weeks
Title
Change in lobular inflammation score
Time Frame
baseline, 12weeks
Title
Change in ballooning score
Time Frame
baseline, 12weeks
Title
Change in lipid profile
Time Frame
baseline, 4weeks, 8weeks, 12weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Seoul St. Mary's Hospital
City
Seoul
State/Province
Banpo-daero Seocho-gu
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Uijeongbu St. Mary's Hospital
City
Uijeongbu
State/Province
Cheonbo-ro Gyeonggi-do
ZIP/Postal Code
480-710
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Daehak-ro Jongno-gu
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Keimyung University Donsan Medical Center
City
Daegu
State/Province
Dalseong-ro Jung-gu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
State/Province
Dongdeok-ro Jung-gu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Chung-ang University Hospital
City
Seoul
State/Province
Heukseok-dong Dongjak-gu
ZIP/Postal Code
156-755
Country
Korea, Republic of
Facility Name
ASAN Medical Center
City
Seoul
State/Province
Olympic-ro 43-gil, Songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Boramae Hospital
City
Seoul
State/Province
Sindaebang-dong Dongjak-gu
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
Hanyang University Medical Center
City
Seoul
State/Province
Wangsimni-ro Seongdong-gu
ZIP/Postal Code
133-792
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
State/Province
Yonsei-ro Seodaemun-gu
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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