Sciwind Biosciences Co., Ltd., a China-based clinical-stage biopharmaceutical company, announced on Monday that it has started patient dosing in phase three clinical trials of ecnoglutide (XW003) in adult patients with type two diabetes in China.

The company said that ecnoglutide, a novel, long-acting glucagon-like peptide-1 (GLP-1) analogue, is optimised for improved biological activity, cost-effective manufacturing, and once-weekly dosing. It was indicated to be safe and well tolerated, and to result in robust HbA1c and weight decrease in Phase two clinical trials.

The first Phase 3 trial (NCT05680155) of the pivotal study is a multicentre, double-blind, randomised, placebo-controlled trial to evaluate the efficacy and safety of once-weekly subcutaneous administration of ecnoglutide in approximately 210 treatment-naïve patients with type 2 diabetes. Participants in the trial, which is being conducted at approximately 35 sites in China, will be treated with the study drug for up to 52 weeks, followed by a 5-week follow-up period. The second Phase 3 trial (NCT05680129) is a multicentre, open-label, randomised study to evaluate the efficacy and safety of XW003 versus dulaglutide in patients with type 2 diabetes whose diseases have not been adequately controlled with metformin therapy. Participants in the trial will receive ecnoglutide or dulaglutide for 52 weeks, followed by a 5-week follow-up period.

Up to 600 participants will be enrolled in this study at approximately 60 sites in China.