Mei Shan Shi

This trial investigates the effects of TQA2225/AP025, a recombinant human FGF21-Fc fusion protein, in adults with Non-Alcoholic Steatohepatitis (NASH). It is a randomized, double-blind, placebo-controlled Phase II study designed to evaluate the safety and effectiveness of two different doses (25mg and 50mg) of this drug compared to a placebo. Participants have a confirmed diagnosis of NASH based on liver biopsy and imaging, and the study aims to assess changes in liver health over time. Participants receive either 25mg or 50mg of TQA2225/AP025 or a matching placebo, and the treatment is administered during the study period. The trial compares the impact of these doses on liver fibrosis and inflammation, as measured by liver biopsy scores and imaging results. The study includes a treatment duration of 48 weeks, during which the drug's effect on liver tissue is closely monitored. During the study, participants undergo liver biopsies at baseline and after 48 weeks to evaluate liver changes. Additional assessments include MRI scans to measure liver fat content, laboratory tests to monitor liver enzymes and kidney function, and safety evaluations. Researchers will track participants' adherence to the treatment and monitor any side effects or changes in health status throughout the 48-week period.

Researchers are investigating the safety and effectiveness of an amino acid (15) peritoneal dialysis solution in people with end stage renal disease (ESRD) who are undergoing peritoneal dialysis and have malnutrition. This Phase IV, multicenter, randomized study compares this amino acid solution with the standard glucose peritoneal dialysis solution in patients receiving continuous ambulatory peritoneal dialysis (CAPD) maintenance therapy. The goal is to understand how this new dialysis solution may impact patients' nutritional status and overall health. Participants are randomly assigned to one of two groups. The experimental group receives one 2-liter bag of amino acid (15) peritoneal dialysis solution each morning, followed by conventional glucose peritoneal dialysate (lactate). The control group receives conventional glucose peritoneal dialysis solution including a 2-liter bag of 1.5% glucose peritoneal dialysis solution daily. Researchers adjust the number of exchanges, fluid volume, and dwell time based on patient needs. The treatment period lasts 90 days. During the study, participants undergo blood routine and biochemical tests at 30, 60, and 90 days to monitor safety and effects. Nutritional and dialysis-related measures such as normalized protein nitrogen appearance (nPNA), arm muscle circumference (AMC), mid-arm muscle circumference (MAMC), subjective global assessment (SGA), body mass index (BMI), and dialysis adequacy (Kt/V) are evaluated at 90 days. Researchers also record total daily ultrafiltration volume and any adverse events throughout the treatment. The study aims to assess the impact of the dialysis solutions on patients' nutrition and safety over the three-month period.