Clinical trial NCT02029586: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nonalcoholic Fatty Liver Disease
Lead sponsor: Yungjin Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-08
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in hepatic steatosis(%)
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Proportion of subjects with more than 1 point in total NAFLD Activity Score (NAS)
timeFrame: baseline, 12 weeks
measure: Change in fibrosis score
timeFrame: baseline, 12 weeks
measure: Change in steatosis score
timeFrame: baseline, 12weeks
measure: Change in lobular inflammation score
timeFrame: baseline, 12weeks
measure: Change in ballooning score
timeFrame: baseline, 12weeks
measure: Change in lipid profile
timeFrame: baseline, 4weeks, 8weeks, 12weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
state: Banpo-daero Seocho-gu
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital
state: Cheonbo-ro Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Daehak-ro Jongno-gu
city: Daegu
country: Korea, Republic of
facility: Keimyung University Donsan Medical Center
state: Dalseong-ro Jung-gu
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Dongdeok-ro Jung-gu
city: Seoul
country: Korea, Republic of
facility: Chung-ang University Hospital
state: Heukseok-dong Dongjak-gu
city: Seoul
country: Korea, Republic of
facility: ASAN Medical Center
state: Olympic-ro 43-gil, Songpa-gu
city: Seoul
country: Korea, Republic of
facility: Boramae Hospital
state: Sindaebang-dong Dongjak-gu
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
state: Wangsimni-ro Seongdong-gu
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Yonsei-ro Seodaemun-gu
Study officials:
References: