Eligible patients (visit 2) were randomized to D-002 (50 mg) or placebo tablets to be taken twice daily for 24 weeks, and were advised to follow a low-fat low-energy diet (50% carbohydrates, 20% protein, 30% fat) [25]. selleckbio These dietary conditions were supposed to be followed from enrollment to the end of the study. Subjects were seen at weeks 6, 12, 18, and 24 weeks (visits 3 to 6) of the treatment period. Physical examinations (determination of body mass index [BMI], blood pressure, and heart rate) and clinical assessments were conducted at each visit. Treatment compliance and adverse events (AEs) were controlled from visits 3 to 6, laboratory testing was performed at baseline and every 12 weeks, while hepatic fat infiltration was assessed by upper abdominal ultrasonography at baseline and week 24.

Patients We enrolled patients of both sexes, aged 25 to 70 years, with a prior diagnosis of NAFLD and/or persistent increase in liver enzymes without excessive alcohol ingestion (weekly consumption �� 70 g in female, �� 40 g in male), confirmed by careful questioning of the patients and their primary doctors. Enrolled patients were eligible for randomization if liver fat infiltration was confirmed by ultrasonography [26]. Exclusion criteria included overuse of alcohol, viral hepatitis, hemochromatosis, Wilson disease, autoimmune hepatitis, primary sclerosing cholangitis, or primary biliary cirrhosis; history of any other hepatic disorder, glucose values > 7 mmol/L (uncontrolled diabetes), inability to provide written informed consent; pregnancy, breastfeeding, and lack of effective birth control in women of child-bearing age.

Also, patients who had had unstable angina, myocardial infarction, stroke or any serious AE within the 3 months prior to the study were excluded. Moreover, patients were excluded if they were receiving any treatment that could influence liver function. Treatment The study drugs (D-002 or identical placebo tablets) were taken twice per day (at lunch and dinner) for 24 weeks, so that treated patients received D-002 100 mg/day, a dose within the range approved in humans [27]. Randomization was computer-generated using blocks and a 1/1 randomization ratio. Treatments were given in identical coded packages accordingly. Consumption of drugs with recognized or suggested antioxidant, liver protective, or hepatotoxic effects was not allowed.

Treatment compliance was assessed by counting the remaining tablets with Cilengitide respect to those that should be consumed in each period. To be acceptable, �� 85% of the tablets scheduled for a period must have been consumed. Diet adhesion was followed by using special chart records filled by patients and reviewed by doctors, and by recording body weight at each visit. Efficacy variables The primary endpoint was a significant reduction in liver fat infiltration as assessed by ultrasonography, as compared to the placebo recipients.