Investigators of the Multi-Center ESG Randomized Interventional (MERIT) study, which is comparing Endoscopic Sleeve Gastroplasty (ESG) to medically supervised moderate intensity lifestyle, have revealed the trial has achieved its primary endpoints for both efficacy and safety based on a preliminary analysis.
The MERIT study (NCT03406975) is a multi-centre, prospective randomized clinical trial evaluating the safety and effectiveness of the ESG procedure, a minimally invasive, endoscopic weight loss procedure performed with Apollo Endosurgery's OverStitch Endoscopic Suturing System compared to a medically monitored regimen of diet and healthy lifestyle. The study's primary efficacy endpoint is percent excess body weight loss (%EBWL) vs. control, and the primary safety endpoint is a serious adverse event rate of less than 5%. Additionally, patients undergoing ESG are being evaluated for improvement in hypertension and type 2 diabetes at 24 months.
"I am very pleased to report that, in a preliminary analysis, the MERIT study comparing the Endoscopic Sleeve Gastroplasty (ESG) procedure to medically supervised moderate intensity lifestyle modification has achieved its primary endpoints for both efficacy and safety,” said co-primary investigator od the MERIT study, Dr Barham Abu Dayyeh, Professor of Medicine and Director of Advanced Endoscopy at the Mayo Clinic, in a presentation at the 2021 Surgical Disruptive Technologies Summit meeting in Houston, TX. “We hope to present the detailed study results at an international medical conference later this year."
The MERIT study investigators have submitted an abstract to the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO), and if accepted, the full results will be presented at the IFSO annual meeting in Miami in October.
"We are delighted that the Mayo Clinic's preliminary analysis showed the successful achievement of the MERIT study's primary endpoints for weight loss and safety, and we look forward to the publication of the full MERIT results providing an important addition to the substantial body of evidence for the ESG procedure," said Chas McKhann, President and CEO of Apollo Endosurgery. "We plan to utilise the MERIT study results, along with real world evidence, in a submission to the FDA to potentially add a new indication for ESG."
The co-primary investigator is Dr Erik Wilson, University of Texas at Houston (Houston, TX), under a collaborative research agreement sponsored by Apollo Endosurgery.