Liraglutide 3.0 mg once daily for the treatment of overweight and obesity in patients hospitalised at a forensic psychiatric department: A 26‐week open‐label feasibility study

Abstract

AbstractIntroductionOverweight and obesity constitute a major concern among patients treated at forensic psychiatric departments. The present clinical feasibility study aimed at investigating the extent to which glucagon‐like peptide 1 receptor agonist (GLP‐1RA) treatment with once‐daily liraglutide 3.0 mg could be a feasible pharmacological treatment of these conditions in patients with schizophrenia spectrum disorders hospitalised in forensic psychiatry.MethodsThe 26‐week, open‐label feasibility study included participants aged 18–65 years diagnosed with a severe mental illness and hospitalised at a forensic psychiatric department. At the time of inclusion, all participants fulfilled the indication for using liraglutide as a treatment for overweight and obesity. Participants' baseline examinations were followed by a 26‐week treatment period with liraglutide injection once daily according to a fixed uptitration schedule of liraglutide, with a target dose of 3.0 mg. Each participant attended seven visits to evaluate the efficacy and adverse events. The primary endpoint was the number of “completers”, with adherence defined as >80% injections obtained in the period, weeks 12–26. Determining whether liraglutide is a feasible treatment was pre‐defined to a minimum of 75% completers.ResultsTwenty‐four participants were included in the study. Sex, male = 19 (79.2%). Mean age: 42.3 [25th and 75th percentiles: 39.1; 48.4] years; body mass index (BMI): 35.7 [31.7; 37.5] kg/m2; glycated haemoglobin (HbA1c): 37 [35; 39] mmol/mol. Eleven out of 24 participants (46%) completed the study. For the completers, the median net body weight loss after 26 weeks of participation was −11.4 kg [−15.4; −5.9]. The net difference in HbA1C and BMI was −2.0 mmol/mol [−4; −1] and −3.6 kg/m2 [−4.7; −1.8], respectively. The weight change and reduction in HbA1c and BMI were all statistically significant from baseline.ConclusionThe study did not confirm our hypothesis that liraglutide is a feasible treatment for a minimum of 75% of the patients initiating treatment with liraglutide while hospitalised in a forensic psychiatric department. The high dropout rate may be due to the non‐naturalistic setting of the clinical trial. For the proportion of patients compliant with the medication, liraglutide 3.0 mg was an efficient treatment for overweight.