Improved health‐related quality of life with semaglutide in people with non‐alcoholic steatohepatitis: A randomised trial
Manuel Romero‐Gómez, Matthew J. Armstrong, Jesús Funuyet‐Salas, Kamal Kant Mangla, Steen Ladelund, Anne‐Sophie Sejling, Ichhya Shrestha, Arun J. Sanyal- Pharmacology (medical)
- Gastroenterology
- Hepatology
Summary
Background
Non‐alcoholic steatohepatitis (NASH) can adversely affect health‐related quality of life (HRQoL).
Aims
This double‐blind, placebo‐controlled, phase 2 trial aimed to report the effects of the glucagon‐like peptide‐1 receptor agonist, semaglutide, on HRQoL in patients with NASH as a secondary endpoint.
Methods
Adults with biopsy‐proven NASH and stage 1–3 fibrosis were randomised (3:3:3:1:1:1) to once‐daily subcutaneous semaglutide 0.1, 0.2 or 0.4 mg, or placebo, for 72 weeks. Patients were invited to complete the Short Form‐36 version 2.0 questionnaire at weeks 0, 28, 52 and 72.
Results
Between January 2017 and September 2018, 320 patients were enrolled. At 72 weeks, semaglutide was associated with significant improvements in physical component summary (PCS) score (estimated treatment difference [ETD] 4.26; 95% confidence interval [CI]: 1.96–6.55; p = 0.0003); bodily pain (ETD 5.07; 95% CI: 2.15–7.99; p = 0.0007); physical functioning (ETD 3.51; 95% CI: 1.16–5.86; p = 0.0034); role limitations due to physical health problems (ETD 2.80; 95% CI: 0.28–5.33; p = 0.0294); social functioning (ETD 3.16; 95% CI: 0.53–5.78; p = 0.0183) and vitality (ETD 4.47; 95% CI: 1.63–7.32; p = 0.0021). There was no significant difference in the mental component summary score (ETD 1.02; 95% CI: −1.59 to 3.62; p = 0.4441). After 72 weeks, improvements in PCS scores were significantly greater in patients (pooled semaglutide and placebo) with NASH resolution than without (p = 0.014).
Conclusions
Treatment with semaglutide is associated with improvements in the physical components of HRQoL in patients with biopsy‐proven NASH and fibrosis compared with placebo.