Endoscopic sleeve gastroplasty for the treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre and randomized trial

Background

Endoscopic sleeve gastroplasty (ESG) is an organ-sparing endoluminal therapy for obesity widely adopted around the world. Our aim was to explore the efficacy and safety of ESG with lifestyle modifications compared to lifestyle modifications alone.

Methods

We conducted a randomized clinical trial at nine US centers, recruiting people aged 21 to 65 with Class 1 or Class 2 obesity who agreed to abide by lifelong dietary restrictions. Participants were randomly assigned (1:1 5; with stratified permuted blocks) to ESG with lifestyle modifications (ESG group) or lifestyle modifications alone (control group), with a tightening potential or a switch to ESG, respectively, at 52 weeks. Lifestyle modifications included a low-calorie diet and physical activity. Participants in the primary SAE group were followed for 104 weeks. The primary endpoint at 52 weeks was percent excess weight loss (EWL), with excess weight above ideal weight for a BMI of 25 kg/m2. Secondary endpoints included change in metabolic comorbidities between groups. We used several imputed intention-to-treat analyzes with mixed-effects models. Our analyzes were performed on a per-protocol basis and on a modified intention-to-treat basis. The safety population was defined as all participants who underwent SAE (both primary and crossover SAE) up to 52 weeks.

Results

Between December 20, 2017 and June 14, 2019, 209 participants were randomly assigned to GSS (n=85) or control (n=124). At 52 weeks, the primary endpoint of mean percent EWL was 49.2% (SD 32.0) for the ESG group and 3.2% (18.6) for the control group (p

Interpretation

ESG is a safe intervention that resulted in significant weight loss, maintained at 104 weeks, with significant improvements in metabolic comorbidities. ESG should be considered a synergistic weight loss intervention for patients with Class 1 or Class 2 obesity. This trial is registered with ClinicalTrials.gov, NCT03406975.

Funding

Apollo Endosurgery, Mayo Clinic.

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