Mei Shan Shi

This research aims to evaluate the safety and effectiveness of TQA2225AP025, 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 assess how well two different doses of this treatment work in managing NASH, a liver condition characterized by fat buildup and inflammation. Participants will receive either 25mg or 50mg of TQA2225AP025 or a matching placebo, given by weekly subcutaneous injections for 48 weeks. The study includes two experimental groups receiving the different doses, and all treatments are administered under blinded conditions to assess the treatment effects accurately. During the study, participants will undergo liver biopsies at the start and after 48 weeks to measure changes in liver condition using the NASH CRN scoring system. Safety will be closely monitored by tracking any adverse events throughout the treatment period. The study is expected to provide detailed information on both the treatment impact on liver health and its safety profile over nearly a year of participation.

Researchers are evaluating the safety and effectiveness of an amino acid 15 peritoneal dialysis solution in patients undergoing peritoneal dialysis who have malnutrition. This Phase IV, multicenter, randomized, parallel controlled study focuses on patients receiving continuous ambulatory peritoneal dialysis CAPD maintenance treatment. The goal is to compare the amino acid solution with conventional glucose peritoneal dialysis solution in this population with End Stage Renal Disease ESRD. Participants are randomly assigned to one of two groups an experimental group receiving one bag of amino acid 15 peritoneal dialysate 2 liters each morning followed by conventional glucose dialysate, and a control group receiving conventional glucose peritoneal dialysis solution including 1.5% glucose dialysate 2 liters once daily. The number of dialysate exchanges, fluid volume, and dwell times are adjusted based on individual patient needs. The treatment period lasts 90 days, during which safety and effectiveness are monitored. Participants undergo screening, baseline assessments, and regular monitoring throughout the study. Blood tests and biochemical markers are checked at 30, 60, and 90 days, including serum albumin, transferrin, and prealbumin levels. Nutritional and physical assessments such as subjective global assessment SGA, arm muscle circumference AMC, mid-arm muscle circumference MAMC, body mass index BMI, and protein nitrogen appearance nPNA are evaluated at 90 days. The study also tracks total daily ultrafiltration volume and records all adverse events. The entire participation timeline includes a screening period before treatment and close observation during the 90-day treatment phase.