Oral HRS-7535 improves glycaemic control in phase II type 2 diabetes trial

A multicentre, randomised, double-blind, placebo-controlled phase II trial evaluated HRS-7535, an oral small-molecule GLP-1 receptor agonist, in 155 Chinese adults with type 2 diabetes inadequately controlled by metformin and SGLT2 inhibitors. Participants received 30 mg (n=51), 60 mg (n=53) or placebo (n=51) once daily. Mean baseline HbA1c was 8.5%; the primary endpoint was change in HbA1c at week 16.

Least-squares mean HbA1c reductions were 1.5 percentage points with 30 mg, 1.8 points with 60 mg and 0.4 points with placebo (p<0.0001 for each active dose versus placebo). HbA1c below 7.0% was achieved by 51.0%, 66.0% and 9.8%, respectively. Body weight decreased by 2.4% with 60 mg versus 0.7% with placebo.

Most treatment-emergent adverse events were mild to moderate, with gastrointestinal events most common. No severe hypoglycaemia was reported, and the only adverse event leading to treatment discontinuation occurred in the placebo group. These findings support further evaluation as add-on therapy, but the small sample, 16-week duration and exclusively Chinese population limit conclusions about long-term safety and generalisability. HbA1c and weight findings do not establish cardiovascular or renal benefit. The study was funded by Jiangsu Hengrui Pharmaceuticals.