Effect of Swallow Balloon Therapy with the Combination of Semaglutide Oral Formulation: a Randomised Double-Blind Single-Centre Study.

BACKGROUND: Obesity is a significant public health issue; new therapies and pharmaceutical approaches to weight management are needed. OBJECTIVE: This study assesses weight reduction efficacy in the novel swallow balloon procedure and semaglutide, both promising non-surgical and pharmaceutical options, addressing obesity's critical public health challenge. METHODS: This was a computer-generated, blocked randomisation, double-blind, single-centre study. Fifty-seven participants were assigned to swallow balloon therapy group I (with semaglutide), and 58 were assigned to swallow balloon therapy group II (without semaglutide). All treatment doses were orally administered once daily (3 mg for the 1 month, 7 mg for the 2 month, and 14 mg for the 3 and 4 months after the placement of the swallow balloon). All the data were statistically analysed. RESULTS: The groups were highly well-matched. The %TWL in group I was 7.9%, 12.5%, 15.2%, and 17.6% and in group II was 6.1%, 10.5%, 12.8%, and 13.7% at 1, 2, 3, and 4 months, respectively. The most common adverse events (AEs) were nausea and vomiting, observed within the week. The resolution of T2DM, HTN, and OSA was 64.7% vs 55.5%, 64.3% vs 58.8%, and 72.0 vs 57.8% in groups I vs II, respectively. QoL significantly improved 4 months postoperatively in both groups. No major late complications occurred in either of the groups. CONCLUSION: The study supports the efficacy of swallow balloon therapy combined with semaglutide oral formulation in promoting weight loss and improving comorbid conditions. The findings highlight the potential of this combined approach in managing obesity and its associated health issues.