Semaglutide Formulations Show Non-Inferior Efficacy and Safety for Weight Management in Indian Adults with Obesity

Approximately 33-46% of people in India are affected by obesity, a major risk factor for several non-communicable diseases. While semaglutide injection, a glucagon-like peptide-1 (GLP-1) receptor agonist, is highly effective for weight management, its high cost limits accessibility. This economic barrier creates a significant gap in public health efforts to combat obesity. This study addresses the critical need for more affordable, yet equally effective, treatment options to broaden access to proven pharmacological interventions.

The "Size Plus Study" was a Phase III, randomized, non-inferiority, active-controlled trial designed to evaluate the comparative efficacy and safety of a novel semaglutide injection formulation against the established reference semaglutide for chronic weight management. The study enrolled Indian adults with obesity, aiming to determine if the new formulation was not clinically worse than the reference product. Participants were randomized to receive either the investigational once-weekly semaglutide formulation or the reference once-weekly semaglutide. The primary endpoint focused on assessing the non-inferiority of the investigational product in terms of weight reduction and overall safety profile over the study duration.