Synthesized semaglutide HD1916 meets weight-loss equivalence criterion versus Wegovy in phase III trial

A multicenter, randomized, open-label phase III trial published in Diabetes, Obesity and Metabolism compared chemically synthesized semaglutide HD1916 with reference semaglutide (Wegovy). At 30 centers in China, 462 adults aged 18–75 years with BMI ≥28 kg/m² and without diabetes were assigned equally to once-weekly subcutaneous treatment for 44 weeks. The primary endpoint was percentage change in body weight, with equivalence defined by a 95% confidence interval for the between-group difference within ±4.16 percentage points.

Mean weight decreased by 13.1% with HD1916 and 14.4% with Wegovy. The estimated difference was 1.35 percentage points (95% CI, −0.02 to 2.72), meeting the prespecified equivalence criterion. Weight loss of at least 5% occurred in 87.8% versus 90.5%, and at least 10% in 68.7% versus 73.6%, respectively. Waist-circumference reductions were described as comparable, without numerical results in the abstract. Any-grade treatment-emergent adverse events occurred in 86.5% and 89.2%; most were grade 1–2.

The findings support comparable weight-loss efficacy over 44 weeks within the trial’s equivalence margin. Interpretation is limited by the open-label design and the population restricted to Chinese adults without diabetes. Only the abstract was available; detailed safety outcomes, dosing, missing-data handling, and funding disclosures could not be assessed.