New Semaglutide Injection Shows Similar Weight Loss to Reference Drug in Indian Adults

Obesity is a growing global health concern, significantly increasing the risk of conditions like type 2 diabetes, cardiovascular disease, and certain cancers. Semaglutide, a GLP-1 receptor agonist, has proven highly effective for chronic weight management. However, accessibility and cost can be barriers in many regions. This Phase III trial aimed to determine if a new, locally manufactured semaglutide injection is non-inferior in efficacy and safety to the established reference semaglutide for weight management in Indian adults with obesity.

The study found that the novel semaglutide injection was non-inferior to the reference semaglutide for chronic weight management. Participants receiving the novel semaglutide achieved a mean body weight reduction of 15.8% (standard deviation ± 4.2%) from baseline, while the reference semaglutide group achieved a mean reduction of 16.5% (standard deviation ± 4.0%). The estimated treatment difference was -0.7% (95% CI: -1.5% to 0.1%), which was well within the pre-specified non-inferiority margin of -4% (p<0.001 for non-inferiority). A significantly higher proportion of participants in the novel semaglutide group (72%) achieved at least 10% body weight loss, compared to 75% in the reference group, with no statistically significant difference (p=0.32). Safety profiles were also comparable, with 82% of novel semaglutide recipients and 85% of reference semaglutide recipients reporting at least one adverse event, primarily mild-to-moderate gastrointestinal issues like nausea (45% vs 48%) and diarrhea (30% vs 33%). Serious adverse events occurred in 3% of both groups, with no new safety signals identified.