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

Obes Surg. 2024 Jan;34(1):198-205. doi: 10.1007/s11695-023-06975-8. Epub 2023 Dec 13.

Abstract

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 1st month, 7 mg for the 2nd month, and 14 mg for the 3rd and 4th 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.

Keywords: Non-surgical approach; Obesity; Semaglutide; Swallow balloon; Weight loss.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Diabetes Mellitus, Type 2* / drug therapy
  • Double-Blind Method
  • Humans
  • Hypoglycemic Agents* / therapeutic use
  • Obesity, Morbid* / drug therapy
  • Obesity, Morbid* / surgery
  • Quality of Life
  • Treatment Outcome
  • Weight Loss

Substances

  • Hypoglycemic Agents
  • semaglutide