NCT02029586

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

10 active sites

Status
terminated

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

January 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 21, 2017

Status Verified

December 1, 2017

Enrollment Period

1.8 years

First QC Date

January 6, 2014

Last Update Submit

December 19, 2017

Conditions

Nonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

MB12066

EXPERIMENTAL
Drug: MB12066 200mg

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MB12066 200mgDRUG

oral administration, 100mg bid

MB12066
PlaceboDRUG

oral administration, 100mg bid

Placebo

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Seoul St. Mary's Hospital

Seoul, Banpo-daero Seocho-gu, 137-701, South Korea

Location

Uijeongbu St. Mary's Hospital

Uijeongbu-si, Cheonbo-ro Gyeonggi-do, 480-710, South Korea

Location

Seoul National University Hospital

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

Location

Keimyung University Donsan Medical Center

Daegu, Dalseong-ro Jung-gu, 700-712, South Korea

Location

Kyungpook National University Hospital

Daegu, Dongdeok-ro Jung-gu, 700-721, South Korea

Location

Chung-ang University Hospital

Seoul, Heukseok-dong Dongjak-gu, 156-755, South Korea

Location

ASAN Medical Center

Seoul, Olympic-ro 43-gil, Songpa-gu, 138-736, South Korea

Location

Boramae Hospital

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

Location

Hanyang University Medical Center

Seoul, Wangsimni-ro Seongdong-gu, 133-792, South Korea

Location

Severance Hospital

Seoul, Yonsei-ro Seodaemun-gu, 120-752, South Korea

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

beta-lapachone

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2014

First Posted

January 8, 2014

Study Start

January 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

December 21, 2017

Record last verified: 2017-12

Locations

KR(10)