A Novel Prescription Digital Therapeutic Option for the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease

Background and aims: Metabolic dysfunction-associated steatotic liver disease and metabolic dysfunction-associated steatohepatitis are pressing public health problems occurring alongside the rising prevalence of obesity and diabetes. This feasibility study explored the use of a novel prescription digital therapeutic (PDT) in this patient population.

Methods: A prospective, open-label study was conducted at two hepatology clinics. Eligible patients had a baseline FibroScan controlled attenuation parameter >274 dB/m. Participants were given access to a PDT containing a novel form of cognitive behavioral therapy designed to treat cardiometabolic disease. Laboratory assessments, FibroScan, and magnetic resonance imaging proton density fat fraction (MRI-PDFF) imaging were conducted preintervention and postintervention.

Results: Twenty-two participants were enrolled. Mean baseline fat fraction on MRI-PDFF was 18.7%. After the 90-day intervention, the mean relative reduction in MRI-PDFF was -16.2% (P = .011) in those with baseline PDFF ≥10%. Mean alanine transaminase decreased by -17.1 IU/L (P = .002). Participants achieved an average total body weight loss of -2.9% (P = .008) and controlled attenuation parameter score was reduced by -18.8 dB/m (P = .021). No serious or device-related adverse events were reported. An average improvement in health-related quality of life of +2.2 Healthy Days per month (P = .500) and high treatment satisfaction (mean Net Promoter Score of +75) were reported.

Conclusion: After 90 days of digitally delivered cognitive behavioral therapy, improvements were observed in multiple endpoints without any adverse device effects. The safety, efficacy, and usability data observed strengthen the hypothesis that PDTs provide a scalable tool to address unmet behavioral treatment needs in metabolic dysfunction-associated steatotic liver disease and metabolic dysfunction-associated steatohepatitis (ClinicalTrials.gov number, NCT05357248).