Efficacy and Safety of Chemically Synthesized Semaglutide Injection (HD1916) for the Treatment of Obesity: A Multicenter, Randomized, Phase III Trial.

Aims

To evaluate whether HD1916, a chemically synthesised semaglutide, is therapeutically equivalent to the reference product semaglutide (Wegovy) in body weight reduction among Chinese adults with obesity without diabetes.

Materials And Methods

This multicenter, randomised, open-label, active-controlled Phase III trial was conducted at 30 centers in China. Adults aged 18-75 years with obesity (BMI ≥ 28 kg/m2) and without diabetes were randomised 1:1 to receive once-weekly subcutaneous HD1916 or semaglutide for 44 weeks. The primary endpoint was the percentage change in body weight from baseline to week 44. Equivalence was established if the 95% confidence interval (CI) of the between-group difference was within the prespecified margin of ±4.16%. Key secondary endpoints included the proportions of participants achieving ≥ 5% and ≥ 10% weight loss and change in waist circumference.

Results

A total of 462 participants were randomised (231 per group). At week 44, mean body weight decreased by 13.1% with HD1916 and 14.4% with semaglutide. The estimated treatment difference was 1.35% (95% CI, -0.02 to 2.72), which fell within the equivalence margin, confirming therapeutic equivalence. Proportions of participants achieving ≥ 5% weight loss (87.8% vs. 90.5%) and ≥ 10% weight loss (68.7% vs. 73.6%), as well as reductions in waist circumference, were comparable between groups. Any-grade treatment-emergent adverse events occurred in 86.5% and 89.2% of participants in the HD1916 and semaglutide groups, respectively; most were Grade 1-2.

Conclusions

HD1916 demonstrated equivalent body weight reductions to the reference product semaglutide (Wegovy), with a comparable safety profile.