A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Placebo in T2DM Patients

Phase 3 Completed 211 enrolled Hangzhou Sciwind Biosciences Co., Ltd.

RandomizedParallel-groupDouble-blindTreatment

Summary

The main purpose of this study is to investigate the efficacy and safety of XW003 versus placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled by diet and exercise alone

Timeline

Start: 2022-12-29
Primary completion: 2024-06-12
Completion: 2024-10-12

Outcome

Met primary endpoint

paper The estimated treatment differences versus placebo were -1.09% (95% CI -1.40 to -0.77; p = 0.0003) with ecnoglutide 0.6 mg PMID 41501026 ↗

paper -1.56% (95% CI -1.87 to -1.24; p < 0.0001) with ecnoglutide 1.2 mg. PMID 41501026 ↗

Publications

Zhu D, Wang W, Tong G, Ma J, Wen B, Zheng X, Shi B, Pang S, Wang K, Shi X, Zhang X, Fu L, Liu Y, Lu Y, Huang D, Jiang C, Pan T, Xue H, Han J, Ding H, Bing S, Jiang F, Zheng Q, Yang M, Guan L, Liu X, Ning J, Bu Y, Guo M, Yang L, Guo W, Li Y, Xu S, Pan H. Efficacy and safety of cAMP signalling-biased GLP-1 analogue ecnoglutide monotherapy versus placebo in patients with type 2 diabetes (EECOH-1): a multi-centre, randomised, double-blind, placebo-controlled, phase 3 trial. Nat Commun. 2026 Jan 7;17(1):1420. doi: 10.1038/s41467-025-68165-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ecnoglutide	Protein / enzyme biologic	0.6 mg	Subcutaneous
Subject	Ecnoglutide	Protein / enzyme biologic	1.2 mg	Subcutaneous