HRS-7535 is a novel oral small-molecule glucagon-like peptide-1 receptor agonist (GLP-1RA) investigated as an add-on treatment for Chinese adults with type 2 diabetes inadequately controlled despite metformin and SGLT2 inhibitor therapy. In this multicenter, randomized, double-blind, placebo-controlled phase II trial, 155 participants with a mean baseline glycated hemoglobin (HbA1c) of 8.5% received HRS-7535 30 mg (n = 51), HRS-7535 60 mg (n = 53), or placebo (n = 51) once daily for 16 weeks, alongside their existing treatment. At Week 16, HbA1c decreased by 1.5 percentage points with HRS-7535 30 mg and 1.8 percentage points with 60 mg, compared with 0.4 percentage points with placebo (P < 0.0001 for both comparisons).
51.0% with HRS-7535 30 mg, 66.0% with HRS-7535 60 mg, and 9.8% with placebo. Weight loss was −2.4% with HRS-7535 60 mg versus −0.7% with placebo. Most…