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

• Status: Terminated
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: KT&G Life Sciences Corp; Yungjin Pharm. Co., Ltd.
• Treatments: Beta-lapachone

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