A Phase 1b Study of QX1206 in T2DM Patients With NAFLD

Inclusion criteria

• Signed written informed consent must be obtained and documented
• 18 years of age and < 65 years old
• BMI ≥ 18 kg/m^2 and < 45 kg/m^2
• T2DM diagnosed per 2021 American Diabetes Association criteria
• Diagnosis of NAFLD
• For male or female patients of child producing potential: must agree to use contraception or take measures to avoid pregnancy during the study
• Women of child-bearing potential (WOCBP) must have a negative pregnancy test
• Serum creatinine < 1.5×ULN or creatinine clearance ≥ 60 ml/min
• Participating patients must be able to comply with all study requirements and the study center must have appropriate means of ensuring protocol compliance for each participating patient

Exclusion criteria

• Uncontrolled diabetes
• Patients with an active, serious medical disease that limit activities of daily living
• Patients with current, significant alcohol consumption or a history of significant alcohol consumption
• Patients with any of the following clinical laboratory abnormalities at screen and confirmed by a single repeat if deemed necessary:
• Fasting triglycerides > 500 mg/dL
• Fasting direct LDL-C > 190 mg/dL
• AST > 5.0 × upper limit of normal (ULN)
• ALT > 5.0 × ULN
• Alkaline phosphatase (ALP) ≥ 2 × ULN
• HbA1c > 10.5%
• Fasting plasma glucose (FPG) > 240 mg/dL (13.3 mmol/L)
• Platelets count < 140,000/mm^3
• Patient takes drugs historically associated with NAFLD and other known hepatotoxins
• Treatment with drugs (e.g., vitamin E > 400 IU/day) or herbal supplements with potential anti-NAFLD effect