Chiglitazar Added to Metformin for Type 2 Diabetes

Summary

The purpose of the trial is to evaluate the effect of Chiglitazar added to metformin to type 2 diabetes Inadequately controlled with metformin Monotherapy.

Timeline

Start

2021-07-06

Primary completion

2023-02-10

Completion

2023-02-10

Outcome

Met primary endpoint

paper Both chiglitazar 32 mg and 48 mg significantly reduced HbA1c compared to placebo (both p < 0.001) PMID 40842343 ↗

Publications

• Results Ji L, Song W, Fang H, Li W, Geng J, Wang Y, Guo L, Cai H, Yang T, Li H, Yang G, Li Q, Liu K, Li S, Liu Y, Shi F, Li X, Gao X, Tian H, Ji Q, Su Q, Zhou Z, Wang W, Zhou Z, Li X, Xu Y, Ning Z, Cao H, Pan D, Yao H, Lu X, Jia W. 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). Sci Bull (Beijing). 2021 Aug 15;66(15):1571-1580. doi: 10.1016/j.scib.2021.03.019. Epub 2021 Mar 23.
• Results Jia W, Ma J, Miao H, Wang C, Wang X, Li Q, Lu W, Yang J, Zhang L, Yang J, Wang G, Zhang X, Zhang M, Sun L, Yu X, Du J, Shi B, Xiao C, Zhu D, Liu H, Zhong L, Xu C, Xu Q, Liang G, Zhang Y, Li G, Gu M, Liu J, Yuan G, Yan Z, Yan D, Ye S, Zhang F, Ning Z, Cao H, Pan D, Yao H, Lu X, Ji L. Chiglitazar monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomized, double-blind, phase 3 trial (CMAS). Sci Bull (Beijing). 2021 Aug 15;66(15):1581-1590. doi: 10.1016/j.scib.2021.02.027. Epub 2021 Feb 16.
• Gao L, Ji L, Yan X, Cheng Z, Zhang X, Sun W, Ma J, Song W, Liu Y, Lin X, Pang W, Cao H, Chen B, Li Z, Lu X; RECAM Study Group. Efficacy and safety of chiglitazar add-on to metformin in type 2 diabetes mellitus (RECAM study). Diabetes Obes Metab. 2025 Nov;27(11):6243-6253. doi: 10.1111/dom.70009. Epub 2025 Aug 22.

Drugs

Indications