Prospective multicenter real-world pilot study of semaglutide in obese T2DM patients on chronic hemodialysis—a population excluded from semaglutide trials due to advanced kidney failure. Evaluates glycemic control, weight change, body composition, and safety endpoints in HD patients where fluid shifts and protein-energy wasting complicate metabolic management. Provides the first prospective real-world safety and effectiveness data for semaglutide in hemodialysis—critical for determining whether HD patients can safely benefit from GLP-1 RA therapy.
Abstract
Semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1RA) that has demonstrated metabolic and weight benefits in diabetic and obese patients with chronic kidney disease (CKD) who are not on dialysis; however, evidence in the hemodialysis (HD) population is scarce. Weight control and body composition optimization are particularly challenging in HD because of fluid shifts and the risk of protein-energy wasting.This prospective, multicenter, real-world, uncontrolled observational pilot study explored the short-term safety and changes in anthropometric and body-composition parameters after semaglutide initiation in obese adults with type 2 diabetes mellitus (T2DM) undergoing chronic HD. Patients were assessed at baseline and at 3 and 6 months. The primary endpoint was the change in body mass index (BMI), dry weight, and fat mass assessed by bioimpedance spectroscopy (BIS).Thirteen patients were included (10 male, 77%), with a median age of 61.9 years (IQR 55-69). Semaglutide was started at 0.25 mg/week and titrated up to 1 mg/week according to tolerance. Three patients (23.1%) experienced transient nausea that was resolved over time or after dose adjustment, without discontinuation. From baseline to month +6, BMI decreased by a median of 1.5 kg/mand dry weight by 5.0 kg, mainly driven by a median reduction in fat mass of 9 kg; lean tissue mass and serum albumin did not change significantly.In this small, uncontrolled exploratory study, semaglutide was generally well tolerated and was associated with short-term reductions in body weight and fat mass in obese patients with T2DM on HD. These findings are hypothesis-generating and require confirmation in larger controlled prospective studies to define safety and clinical benefit in this population.