Semaglutide safety and tolerability in maintenance dialysis patients to be assessed in new randomized trial

End-stage renal disease (ESRD) patients, particularly those with type 2 diabetes mellitus (T2DM), face significantly elevated risks of cardiovascular events and mortality. Despite the proven cardiovascular and renal protective benefits of Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) like semaglutide in the general T2DM population, individuals on maintenance dialysis have been systematically excluded from major clinical outcome trials. This exclusion leaves a critical gap in evidence regarding the safety, tolerability, and efficacy of these potentially life-saving therapies in a highly vulnerable patient group, limiting treatment options and guidelines for this population.

This 1:1 randomized controlled trial aims to evaluate the safety, tolerability, adherence, and feasibility of a larger cardiovascular outcome trial in patients receiving maintenance dialysis. Participants will be randomized to receive either weekly subcutaneous semaglutide or usual care. The intervention involves weekly subcutaneous injections of semaglutide. Patients will be followed for 26 weeks. Primary endpoints include safety measures (adverse events), tolerability, adherence to the weekly regimen, and the overall feasibility of conducting a definitive cardiovascular outcome trial in this specific population.

This study is a protocol description for an ongoing clinical trial. As such, no clinical outcomes or findings are available yet. The research aims to determine if GLP-1 RAs, specifically semaglutide, are safe and tolerable in the maintenance dialysis population, assess adherence rates, and evaluate the feasibility of conducting a larger, definitive cardiovascular outcome trial in this high-risk group. Results from this trial are pending.