Chemically synthesised semaglutide HD1916 met equivalence with Wegovy for weight loss in Chinese adults

The study

This trial tested whether HD1916, a chemically synthesised version of semaglutide, works as well as the reference product, semaglutide (Wegovy), for weight loss. It was a multicentre, randomised, open-label, active-controlled phase III trial at 30 centres in China.

Adults aged 18-75 years with obesity (BMI ≥ 28 kg/m2) and without diabetes were randomised 1:1. They received once-weekly subcutaneous HD1916 or semaglutide for 44 weeks. A total of 462 participants were randomised, 231 per group.

The primary endpoint was the percentage change in body weight from baseline to week 44. Equivalence was met if the 95% confidence interval (CI) of the between-group difference stayed within ±4.16%.

What they found

At week 44, mean body weight fell by 13.1% with HD1916 and 14.4% with semaglutide. The estimated treatment difference was 1.35% (95% CI, -0.02 to 2.72). This lay inside the equivalence margin, so the authors concluded therapeutic equivalence.

Secondary results were similar between groups:

• Weight loss of at least 5%: 87.8% with HD1916 and 90.5% with semaglutide.
• Weight loss of at least 10%: 68.7% and 73.6%.
• Waist circumference reductions were described as comparable.

Any-grade treatment-emergent adverse events occurred in 86.5% of the HD1916 group and 89.2% of the semaglutide group. Most were Grade 1-2.

How much weight to give it

The design is appropriate for the question. The trial used a randomised, active-controlled equivalence design, with a prespecified margin of ±4.16%. The result met its prespecified margin.

Some limits matter. The trial was open-label, so participants and investigators knew the treatment, which can affect reported symptoms. All participants were Chinese adults without diabetes, so the findings may not apply directly to other groups, such as people with type 2 diabetes. Body weight is the main outcome here. The trial does not show effects on heart disease or other hard outcomes, and those effects should not be assumed from this report.

The point estimate favoured semaglutide numerically, and the lower end of the CI was just below zero. Equivalence was judged against the prespecified margin. The abstract does not report funding, details of serious adverse events, discontinuation rates, or follow-up beyond 44 weeks. It also does not describe the manufacturing process or any immunogenicity testing. The full paper should be read for these points.

For your clinic

This trial supports the idea that a chemically synthesised semaglutide can give weight loss similar to the reference product over 44 weeks in a population like the one studied. It does not tell you how to choose or dose a product for an individual patient.

If you see other semaglutide products being marketed, check each product's approved indication and its own evidence. Results for HD1916 do not automatically apply to other manufacturers' products. Read the full paper, and the relevant regulatory and guideline documents, before changing practice.