Therapeutic Exploratory Phase 2 Study to Evaluate the Safety and Efficacy of MB12066 in Patients With Nonalcoholic Fatty Liver Disease(NAFLD) Except Cirrhosis
NCT ID: NCT02029586
Last Updated: 2017-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
18 participants
INTERVENTIONAL
2013-01-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MB12066
MB12066 200mg
oral administration, 100mg bid
Placebo
Placebo
oral administration, 100mg bid
Interventions
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MB12066 200mg
oral administration, 100mg bid
Placebo
oral administration, 100mg bid
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
20 Years
MALE
Yes
Sponsors
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Yungjin Pharm. Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Seoul St. Mary's Hospital
Seoul, Banpo-daero Seocho-gu, South Korea
Uijeongbu St. Mary's Hospital
Uijeongbu-si, Cheonbo-ro Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, Daehak-ro Jongno-gu, South Korea
Keimyung University Donsan Medical Center
Daegu, Dalseong-ro Jung-gu, South Korea
Kyungpook National University Hospital
Daegu, Dongdeok-ro Jung-gu, South Korea
Chung-ang University Hospital
Seoul, Heukseok-dong Dongjak-gu, South Korea
ASAN Medical Center
Seoul, Olympic-ro 43-gil, Songpa-gu, South Korea
Boramae Hospital
Seoul, Sindaebang-dong Dongjak-gu, South Korea
Hanyang University Medical Center
Seoul, Wangsimni-ro Seongdong-gu, South Korea
Severance Hospital
Seoul, Yonsei-ro Seodaemun-gu, South Korea
Countries
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Other Identifiers
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MB12066_201
Identifier Type: -
Identifier Source: org_study_id