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

Yungjin Pharmaceutical

Status and phase: Terminated; Phase 2

Conditions: Nonalcoholic Fatty Liver Disease

Treatments: Drug: MB12066 200mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02029586

MB12066_201

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

MB12066

Experimental group

Treatment:

Drug: MB12066 200mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo