Efficacy and Safety of Chemically Synthesized Semaglutide Injection (HD1916) for the Treatment of Obesity: A Multicenter, Randomized, Phase III Trial
- Design
- Randomized trial · 462 participants · Intermediate outcome
- Match to healthy normal-weight adults aged 55–75
- Different populationINDIRECT: all participants had obesity (BMI ≥ 28 kg/m2) without diabetes and were Chinese adults aged 18-75 years; mean age and BMI are not reported.
- Could weight loss explain it?
- Not applicableNot applicable: the outcome is body weight change itself.
- Study tier
- Study tier 2MODERATE: open-label randomised phase III trial of 462 people with an intermediate outcome (body weight) over 44 weeks; both arms received semaglutide, so there is no placebo contrast.
- Assessment
- Version 3 · Two independent AI reviews agreed · Oct 19, 2026
Study facts come from the paper. Population match, weight-loss explanation and study tier are our judgments, made against the reference group of healthy normal-weight adults aged 55–75.
In an open-label randomised trial of 462 Chinese adults with obesity and without diabetes, a chemically synthesised semaglutide (HD1916) was compared with the reference product semaglutide (Wegovy) for 44 weeks. Weight fell 13.1% with HD1916 and 14.4% with the reference product, a difference within the prespecified equivalence margin, and side effects were similar (86.5% and 89.2% had any adverse event, mostly Grade 1-2). The trial tests whether two semaglutide products are equivalent, not whether semaglutide works better than no treatment.
01Findings
What the study reported
- Drugs
- Semaglutide
- Route
- subcutaneous
- Treatment duration
- 44 weeks
- Comparator
- reference product semaglutide (Wegovy)
- Primary outcome
- percentage change in body weight from baseline to week 44
- Effect
- Mean body weight fell 13.1% with HD1916 and 14.4% with reference semaglutide; treatment difference 1.35%, within the ±4.16% equivalence margin; ≥ 5% weight loss 87.8% vs. 90.5% and ≥ 10% weight loss 68.7% vs. 73.6%, comparable
- 95% confidence interval
- 95% CI, -0.02 to 2.72
- Follow-up
- 44 weeks
- Adverse events
- Any-grade treatment-emergent adverse events in 86.5% (HD1916) and 89.2% (reference semaglutide); most were Grade 1-2
- Limitations
- Open-label equivalence trial comparing two semaglutide products, so it shows no effect against placebo or no treatment; weight is an intermediate outcome, follow-up was 44 weeks and all participants were Chinese adults with obesity.
Who was studied
- Age range
- 18-75 years
- Age min
- 18
- Bmi min
- 28
- Obesity status
- obesity required (BMI ≥ 28 kg/m2)
- Diabetes status
- excluded
- Cvd status
- not reported in abstract
- Ckd status
- not reported in abstract
- Baseline condition
- obesity
- Sample size
- 462
- Inclusion exclusion
- Chinese adults aged 18-75 years with obesity (BMI ≥ 28 kg/m2) and without diabetes
Study quality details
- Study design
- Randomized controlled trial
- Sample size
- 462
- Randomization
- yes
- Blinding
- open-label
- Comparator
- reference product semaglutide (Wegovy)
- Follow up duration
- 44 weeks
- Outcome type
- intermediate
- Replication
- not assessed
- Consistency with other evidence
- not assessed
- Population applicability
- INDIRECT
- Statistical precision
- 95% CI reported for the between-group difference against a ±4.16% equivalence margin; 462 randomised
- Risk of bias
- not assessed
- Funding conflicts
- unclear
- Peer review status
- yes
02Funding
Funding and conflicts
- Funding
- not reported in abstract
- Industry funded
- Unclear
- Manufacturer
- not stated in source
- Sponsor role
- not reported in abstract
- Author conflicts
- not reported in abstract
- Independent replication
- unknown
Funding is shown on every study and never used to score it.
04Source
The source, as retrieved
Abstract
[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.