Semaglutide to be evaluated for reducing gastrointestinal mucositis and gut barrier injury in auto-HSCT patients

Patients undergoing autologous haematopoietic stem cell transplantation (auto-HSCT) receive high-dose chemotherapy, which often leads to severe gastrointestinal (GI) mucositis. This condition causes significant pain, impairs nutrient absorption, and increases the risk of systemic infections due to gut barrier injury and subsequent systemic inflammation. Current supportive care for mucositis is often insufficient, highlighting an unmet need for targeted therapies. Semaglutide, a GLP-1 receptor agonist, is being explored for its potential anti-inflammatory and gut-protective properties, which could mitigate these severe side effects.

This randomized, double-blind, placebo-controlled, phase 2, two-center clinical study will enroll 40 patients undergoing high-dose chemotherapy and auto-HSCT. Participants will be randomized 1:1 to receive either semaglutide or placebo. The protocol includes a 3-4 week run-in period with semaglutide 0.25 mg once-weekly (QW) subcutaneously (s.c.) prior to chemotherapy, followed by 4-5 weeks of semaglutide 0.5 mg QW. Total investigational drug treatment duration is 8 weeks. The primary objective is to evaluate the effect of semaglutide in reducing the intensity of GI mucositis, with secondary objectives assessing gut barrier injury and systemic inflammation.

This abstract describes a clinical trial protocol, and as such, specific findings and results are not yet available. The study is designed to evaluate the effect of semaglutide on reducing the intensity of gastrointestinal mucositis, gut barrier injury, and systemic inflammation in patients undergoing autologous haematopoietic stem cell transplantation (auto-HSCT). Data collection and analysis will occur after patient enrollment and completion of the study protocol. Therefore, no quantitative results, p-values, or fold-changes can be reported at this stage.