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

Phase 2

Terminated

• Conditions: Nonalcoholic Fatty Liver Disease
• Interventions: Drug: MB12066 200mg; Drug: Placebo

• Registration Number: NCT02029586
• Lead Sponsor: Yungjin Pharm. Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-08
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2017-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MB12066	MB12066 200mg	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in hepatic steatosis(%)	baseline, 12 weeks	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

Name	Time	Method
Change in lobular inflammation score	baseline, 12weeks
Change in steatosis score	baseline, 12weeks
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 lipid profile	baseline, 4weeks, 8weeks, 12weeks
Change in ballooning score	baseline, 12weeks

Trial Locations

Locations (10)

ASAN Medical Center; 🇰🇷 Seoul, Olympic-ro 43-gil, Songpa-gu, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Daehak-ro Jongno-gu, Korea, Republic of

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Banpo-daero Seocho-gu, Korea, Republic of

Uijeongbu St. Mary's Hospital; 🇰🇷 Uijeongbu, Cheonbo-ro Gyeonggi-do, Korea, Republic of

Keimyung University Donsan Medical Center; 🇰🇷 Daegu, Dalseong-ro Jung-gu, Korea, Republic of

Chung-ang University Hospital; 🇰🇷 Seoul, Heukseok-dong Dongjak-gu, Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Dongdeok-ro Jung-gu, Korea, Republic of

Boramae Hospital; 🇰🇷 Seoul, Sindaebang-dong Dongjak-gu, Korea, Republic of

Hanyang University Medical Center; 🇰🇷 Seoul, Wangsimni-ro Seongdong-gu, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Yonsei-ro Seodaemun-gu, Korea, Republic of