Phase 3: chemically synthesized semaglutide HD1916 met equivalence to Wegovy for weight reduction in Chinese adults with obesity
In a 462-participant, 30-center, open-label randomized Phase 3 trial published October 7, 2026 in Diabetes, Obesity and Metabolism, once-weekly HD1916 produced 13.1% average weight loss at week 44 versus 14.4% with reference semaglutide (Wegovy); the 1.35% between-group difference (95% CI -0.02 to 2.72) fell within the prespecified equivalence margin.
The multicenter, randomized, open-label, active-controlled Phase 3 trial was conducted at 30 centers in China and enrolled adults aged 18 to 75 with obesity (BMI at least 28 kg/m2) and without diabetes. A total of 462 participants were randomized 1:1 (231 per group) to once-weekly subcutaneous HD1916, a chemically synthesized semaglutide made by CSPC Pharmaceutical Group, or reference semaglutide (Wegovy) for 44 weeks. The primary endpoint was percentage change in body weight from baseline to week 44; equivalence would be declared if the 95% confidence interval of the between-group difference fell within a prespecified margin of plus or minus 4.16%.
At week 44, mean body weight decreased by 13.1% with HD1916 and 14.4% with reference semaglutide. The estimated treatment difference was 1.35 percentage points (95% CI, -0.02 to 2.72), inside the equivalence margin, so the trial met its primary objective. Secondary outcomes were comparable: at least 5% weight loss was achieved by 87.8% versus 90.5% of participants, at least 10% by 68.7% versus 73.6%, and waist circumference fell by 11.29 cm versus 12.07 cm. Any-grade treatment-emergent adverse events occurred in 86.5% of the HD1916 group and 89.2% of the semaglutide group, mostly grade 1-2.
The paper, published in Diabetes, Obesity and Metabolism on October 7, 2026 (DOI 10.1111/dom.71354), lists first author Leili Gao of Peking University People's Hospital, Beijing. HD1916 is produced by full chemical synthesis rather than the recombinant biological process used for the reference product. CSPC says it has New Drug Applications for type 2 diabetes and for weight management under review by China's National Medical Products Administration; that regulatory status is company-reported and not independently verified here.
Context and limits: the trial was open-label, conducted entirely in China in adults without diabetes, and designed to test equivalence, not superiority, against the reference product at an established dose. HD1916 is not approved in any country, and these results do not change the status of any compounded, gray-market or 'research use only' semaglutide product, none of which is this studied formulation. This brief is not medical advice and does not identify or recommend any seller, prescriber or product.