Semaglutide Bioequivalence Study Compares Two Formulations in Different Pen-injectors for Overweight or Obesity

Semaglutide, a GLP-1R agonist, is a highly effective treatment for type 2 diabetes and obesity, leading to significant weight loss and improved metabolic health. As new formulations or delivery devices for semaglutide emerge, it is critical to ensure their bioequivalence to maintain consistent therapeutic outcomes and patient safety. Bioequivalence studies confirm that different products deliver the same amount of active drug to the bloodstream, which is essential for regulatory approval and for ensuring predictable efficacy in chronic conditions like obesity.

This randomized, open-label study will enroll participants with overweight or obesity to compare the pharmacokinetics (PK) of two distinct semaglutide formulations, each delivered via a different pen-injector. Participants will be randomized to receive one of the two formulations, administered as a once-weekly subcutaneous injection into the abdomen. The protocol involves a total of 21 injections over a 27-30 week treatment period, preceded by a screening phase. Participants will undergo 25 study visits, including two 3-day/2-night in-clinic stays for intensive PK sampling. The primary endpoint is to establish the bioequivalence of the two semaglutide formulations based on their blood concentration profiles.

This is a study protocol, meaning the research is planned but not yet completed, and therefore no findings are available at this time. The primary objective of this trial is to determine the bioequivalence of two different semaglutide formulations when administered via distinct pen-injectors. Successful demonstration of bioequivalence would indicate that the two formulations deliver comparable systemic exposure of semaglutide, ensuring consistent therapeutic effects and safety profiles. This study aims to provide the foundational pharmacokinetic data necessary for potential future regulatory approvals.