Weight management programme plus semaglutide tested in advanced kidney disease
A large pragmatic randomised controlled trial is evaluating a 26-week multicomponent weight management programme—combining virtual coaching, the weight-loss medication semaglutide (up to 2.0 mg/week), and behavioural counselling—against standard obesity care in adults with advanced chronic kidney disease or on dialysis. The study, initiated in September 2024, aims to enrol at least 50 participants in its vanguard phase and assess feasibility, adherence, safety, and weight outcomes.
Obesity management has been largely absent from large randomised controlled trials in advanced chronic kidney disease (CKD) and dialysis populations, leaving a critical evidence gap. The OK-TRANSPLANT 2 study is a pragmatic, open-label RCT designed to fill this gap by testing a 26-week multicomponent intervention that combines monthly virtual coaching, semaglutide (titrated to a maximum 2.0 mg/week), and structured behavioural, dietary, and exercise counselling against standard obesity care.
The trial includes adults aged 18 or older with a body mass index of 35 kg/m² or higher who either receive dialysis or have a 10% or greater risk of progressing to end-stage kidney disease requiring renal replacement therapy within 2 years (assessed using the validated Kidney Failure Risk Equation). The vanguard phase success criterion is recruitment of at least 50 participants (83% of the eventual target) within 12 months of site initiation. Beyond weight loss, the study will assess feasibility and adherence to the intervention, safety outcomes, and acceptability using qualitative methods. Though full results are not yet available (the study targets completion in December 2027), this pragmatic design embedded in routine clinical care may offer insights into whether intensive weight management is both feasible and beneficial for a population historically excluded from obesity trials.
The OK-TRANSPLANT 2 trial addresses a striking research gap: nearly all large weight-loss trials have excluded people with advanced CKD or those on dialysis, despite obesity being a major barrier to kidney transplantation. The intervention is multi-pronged—semaglutide (a GLP-1 receptor agonist) combined with monthly virtual coaching and structured behavioural, dietary, and exercise support—rather than medication alone, reflecting current understanding that sustained weight loss requires lifestyle integration. The pragmatic, open-label design (not blinded) is intentional: it tests the intervention as it would actually be delivered in clinical settings, increasing real-world relevance. Preliminary outcomes from the vanguard phase will measure not just weight change but adherence, retention, and safety signals—critical given the metabolic complexity of advanced kidney disease. The inclusion of qualitative data on acceptability will help determine whether this approach feels sustainable for people managing both obesity and kidney disease simultaneously. Full efficacy results are pending completion in late 2027.
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