Efficacy and safety of chiglitazar, a novel peroxisome proliferator-activated receptor pan-agonist, in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, phase 3 trial (CMAP)

• DOI: 10.1016/j.scib.2021.03.019
• Publication Date: 2021-03-23T17:13:11Z
• Authors: Linong Ji; Weihong Song; Hui Fang; Wei Li; Jianlin Geng; Yangang Wang; Lian Guo; Hanqing Cai; Tao Yang; Hongmei Li; Gangyi Yang; Qifu Li; Kuanzhi Liu; Shuying Li; Yanjun Liu; Fuyan Shi; Xinsheng Li; Xin Gao; Haoming Tian; Qiuhe Ji; Qing Su; Zhiguang Zhou; Wenbo Wang; Zunhai Zhou; Xuejun Li; Yancheng Xu; Zhiqiang Ning; Haixiang Cao; Desi Pan; He Yao; Xianping Lu; Weiping Jia
• Keywords: Clinical endpoint

Chiglitazar (Carfloglitazar) is a novel non-thiazolidinedione (TZD) structured peroxisome proliferator-activated receptor (PPAR) pan-agonist that has shown promising effects on glycemic control and lipid regulation in patients with type 2 diabetes previous clinical studies. This randomized phase 3 trial aimed to compare the efficacy safety of chiglitazar placebo insufficient by strict diet exercise alone. Eligible were randomly assigned receive 32 mg (n = 167), 48 166), or 202) once daily. The primary endpoint was change glycosylated hemoglobin A1c (HbA1c) at week 24 superiority over placebo. results showed both resulted significant clinically meaningful reductions HbA1c, placebo-adjusted estimated treatment differences for −0.87% (95% confidential interval (CI): −1.10 −0.65; P < 0.0001) −1.05% CI: −1.29 −0.81; 0.0001), respectively. Secondary parameters including control, insulin sensitivity triglyceride reduction also significantly improved groups. overall frequency adverse events study discontinuation attributable similar among Low incidences mild edema body weight gain reported dose from this demonstrated PPAR possesses an good profile inadequately controlled lifestyle interventions, thereby providing adequate supporting evidence using as option diabetes.