Research

Chinese Phase 3 Trial Finds 'Chemically Synthesized' Semaglutide Copy Equivalent to Wegovy for Weight Loss

A randomized, active-controlled Phase III trial in 462 Chinese adults with obesity found HD1916, a chemically synthesized semaglutide made by CSPC Baike, produced body-weight reductions statistically equivalent to the reference product semaglutide (Wegovy) over 44 weeks. The trial was published online October 7, 2026 in Diabetes, Obesity and Metabolism.

Peptide Science Daily Staff

A Phase III trial testing a chemically synthesized version of semaglutide against the reference product semaglutide, marketed by Novo Nordisk as Wegovy for weight management, found the two produced statistically equivalent weight loss in Chinese adults with obesity. The trial was published online October 7, 2026 in Diabetes, Obesity and Metabolism.

The test article, HD1916, is manufactured by CSPC Baike (Shandong) Biopharmaceutical Co. Ltd, which sponsored the trial and employed several of the paper's listed authors; the lead and corresponding author is affiliated with Peking University People's Hospital in Beijing. The multicenter, randomized, open-label, active-controlled trial enrolled adults aged 18 to 75 with obesity, defined as a body mass index of 28 kg/m2 or higher under the trial's criteria, and without diabetes, at 30 centers across China. It is registered with ClinicalTrials.gov as NCT06604624.

A total of 462 participants were randomized 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. The trial was designed to demonstrate therapeutic equivalence, not superiority: equivalence would be established only if the 95% confidence interval of the between-group difference fell entirely within a prespecified margin of plus or minus 4.16%.

At week 44, mean body weight had decreased by 13.1% in the HD1916 group and 14.4% in the semaglutide group. The estimated treatment difference was 1.35 percentage points (95% CI, -0.02 to 2.72), which the authors reported fell within the equivalence margin, meeting the trial's primary endpoint. Secondary outcomes were similar between groups: 87.8% of participants on HD1916 and 90.5% on semaglutide lost at least 5% of body weight, while 68.7% and 73.6%, respectively, lost at least 10%; reductions in waist circumference were also comparable.

Any-grade treatment-emergent adverse events occurred in 86.5% of the HD1916 group and 89.2% of the semaglutide group, with the authors describing most as Grade 1 or 2 in severity. The published abstract did not break out specific adverse event types or discontinuation rates.

HD1916 is not approved by the FDA, the European Medicines Agency or Australia's Therapeutic Goods Administration, and this trial did not evaluate or seek approval in any jurisdiction; it compared body-weight outcomes between the two products in a Chinese trial population only. Semaglutide, the reference product, is FDA- and EMA-approved and TGA-registered as Wegovy for chronic weight management and as Ozempic and Rybelsus for type 2 diabetes. The trial results describe outcomes in the population and timeframe studied and do not constitute treatment or dosing guidance.

Sources

  1. Efficacy and Safety of Chemically Synthesized Semaglutide Injection (HD1916) for the Treatment of Obesity: A Multicenter, Randomized, Phase III Trial · Diabetes, Obesity and Metabolism (via PubMed) (2026) (opens in a new tab)
  2. Semaglutide in Treatment of Obesity - registry record NCT06604624 · ClinicalTrials.gov, U.S. National Library of Medicine (2026) (opens in a new tab)
  3. Efficacy and Safety of Chemically Synthesized Semaglutide Injection (HD1916) for the Treatment of Obesity: A Multicenter, Randomized, Phase III Trial - DOI metadata record · Crossref (DOI registration agency) (2026) (opens in a new tab)