A Phase 3 Study to Evaluate the Efficacy of XW003 Compared With Dulaglutide in Participants With T2DM

Summary

The aim of the study is to compare the efficacy and safety of two XW003 doses versus dulaglutide as add-on therapy to metformin in participants with type 2 diabetes mellitus (T2DM)

Timeline

Start

2023-01-10

Primary completion

2024-07-03

Completion

2024-10-12

Outcome

Met primary endpoint

paper Once-weekly ecnoglutide 0·6 mg and 1·2 mg were non-inferior to dulaglutide 1·5 mg in reducing HbA1c PMID 40854315 ↗

paper and -0·24% (-0·38 to -0·11; -2·67 mmol/mol [-4·14 to -1·20]; p=0·0002 for superiority) with ecnoglutide 1·2 mg. PMID 40854315 ↗

paper the 1·2 mg dose showed statistically significantly greater reductions in HbA1c from baseline to week 32 than dulaglutide 1·5 mg PMID 40854315 ↗

Publications

• He Y, Mi N, Cheng Z, Xue H, Han J, Wang H, Wang H, Wu J, Shi X, Zhao S, Duan B, Zhu Y, Zhou Y, Li F, Wang X, Ling H, Wang S, Li Q, Jiang F, Yang M, Bing S, Zheng Q, Ning J, Guo M, Bu Y, Guan L, Li Y, Yang L, Guo W, Pan H, Li X. Efficacy and safety of cAMP-biased GLP-1 receptor agonist ecnoglutide versus dulaglutide in patients with type 2 diabetes and elevated glucose concentrations on metformin monotherapy (EECOH-2): a 52-week, multicentre, open-label, non-inferiority, randomised, phase 3 trial. Lancet Diabetes Endocrinol. 2025 Oct;13(10):863-873. doi: 10.1016/S2213-8587(25)00196-2. Epub 2025 Aug 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Dulaglutide	Peptide	1.5 mg	Subcutaneous
Subject	Ecnoglutide	Protein / enzyme biologic	0.6 mg	Subcutaneous
Subject	Ecnoglutide	Protein / enzyme biologic	1.2 mg	Subcutaneous
Background	Metformin	Small molecule	—	Oral

Indications