Efficacy and safety of visepegenatide, a long-acting weekly GLP-1 receptor agonist as monotherapy in type 2 diabetes mellitus: a randomised, double-blind, parallel, placebo-controlled phase 3 trial

• Published in: The Lancet regional health. Western Pacific 2024-06, Vol.47, p.101101, Article 101101
• Main Authors: Yan, Xiang, Ma, Jianhua, Liu, Yan, Wang, Xuhong, Li, Sheli, Yan, Shuang, Mo, Zhaohui, Zhu, Yikun, Lin, Jingna, Liu, Jie, Jia, Ying, Liu, Li, Ding, Ke, Xu, Michael, Zhou, Zhiguang
• Format: Article
• Language: English
• Subjects: BMI; Diabetes; GLP-1 RA; Glycaemic control; HbA1c; Visepegenatide
• ISSN: 2666-6065; 2666-6065
• DOI: 10.1016/j.lanwpc.2024.101101

Type 2 diabetes (T2DM) remains a challenge to treat despite the expansion of various therapeutic classes. Visepegenatide (PB-119) is a once a week, subcutaneous, glucagon-like peptide-1 receptor agonist (GLP-1 RA) injection without the requirement of dose titration that has shown glycaemic control and safety profile in two phase 2 studies conducted in China and the United States, respectively. The aim of this study was to evaluate the efficacy and safety of visepegenatide as a monotherapy in treatment-naïve patients with T2DM. This was a multicentre, double-blind, parallel, placebo-controlled, phase 3 trial conducted in 30 centres in China. Adult participants (aged 18–75 years) with T2DM, glycated haemoglobin (HbA1c) of 7.5%–11.0% [58.47–96.73 mmol/mol], body mass index (BMI) of 18–40 kg/m2, and who had been treated with diet and exercise alone for at least 8 weeks before the screening visit were eligible for enrolment. After a 4-week placebo injection run-in period, participants with HbA1c of 7.0%–10.5% [53.0–91.3 mmol/mol] and fasting plasma glucose (FPG)