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

Nonalcoholic Fatty Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02029586
• Other study ID #: MB12066_201
• Status: Terminated
• Phase: Phase 2
• First received: January 6, 2014
• Last updated: December 19, 2017
• Start date: January 2013
• Est. completion date: November 2014

Study information

• Verified date: December 2017
• Source: Yungjin Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

Intervention

Drug:
• MB12066 200mg
oral administration, 100mg bid
• Placebo
oral administration, 100mg bid

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Donsan Medical Center	Daegu	Dalseong-ro Jung-gu
Korea, Republic of	Kyungpook National University Hospital	Daegu	Dongdeok-ro Jung-gu
Korea, Republic of	ASAN Medical Center	Seoul	Olympic-ro 43-gil, Songpa-gu
Korea, Republic of	Boramae Hospital	Seoul	Sindaebang-dong Dongjak-gu
Korea, Republic of	Chung-ang University Hospital	Seoul	Heukseok-dong Dongjak-gu
Korea, Republic of	Hanyang University Medical Center	Seoul	Wangsimni-ro Seongdong-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	Severance Hospital	Seoul	Yonsei-ro Seodaemun-gu
Korea, Republic of	Uijeongbu St. Mary's Hospital	Uijeongbu	Cheonbo-ro Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Yungjin Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of subjects with more than 1 point in total NAFLD Activity Score (NAS)		baseline, 12 weeks
Secondary	Change in fibrosis score		baseline, 12 weeks
Secondary	Change in steatosis score		baseline, 12weeks
Secondary	Change in lobular inflammation score		baseline, 12weeks
Secondary	Change in ballooning score		baseline, 12weeks
Secondary	Change in lipid profile		baseline, 4weeks, 8weeks, 12weeks