MERIT Trial: Endoscopic Sleeve Gastroplasty Effectively Treats Obesity
Clinician's Perspective:
• Clinical Efficacy: Participants undergoing Endoscopic Sleeve Gastroplasty (ESG) achieved a mean excess weight loss (EWL) of 49.2% at 52 weeks, compared to just 3.2% in the control group.
• Metabolic Impact: The data reveals that 80% of the ESG cohort experienced significant improvement in one or more metabolic comorbidities (health conditions related to obesity, such as type 2 diabetes or hypertension).
• Weight Maintenance: Longitudinal data confirms that 68% of participants maintained at least 25% of their excess weight loss at the 104-week mark.
• Safety Profile: Serious adverse events occurred in only 2% of the 131 participants who underwent the procedure, with no reported mortality or need for intensive care.
• Total Weight Loss: Beyond excess weight metrics, the ESG group achieved a 13.6% total body weight loss (TBWL) compared to 0.8% in the lifestyle-only group.
The MERIT (Multicenter Endoscopic Sleeve Gastroplasty Randomized Interventional Trial) study, published in *The Lancet*, provides high-level clinical evidence for the efficacy of Endoscopic Sleeve Gastroplasty (ESG) as a treatment for Class 1 and Class 2 obesity (a Body Mass Index between 30.0 and 39.9). ESG is an organ-sparing, endolumenal (performed within the internal space of the stomach) procedure that uses an endoscopic suturing device to reduce the stomach’s volume without the need for traditional surgery.
The MERIT Trial
Researchers conducted this prospective, multicenter, randomized controlled trial across nine sites in the United States. The study enrolled 209 participants, aged 21–65, who were assigned to either the ESG group (combined with lifestyle modifications) or a control group (lifestyle modifications alone). Lifestyle modifications included a calorie-restricted diet and regular physical activity. This design allowed investigators to isolate the specific impact of the endoscopic intervention against the current standard of non-surgical care.
Weight Loss Outcomes and Metabolic Improvements
The primary endpoint focused on the percentage of Excess Weight Loss (EWL). At the 52-week mark, the ESG group demonstrated a mean EWL of 49.2%, while the control group achieved only 3.2%. Furthermore, 77% of the ESG participants reached a threshold of 25% or more EWL, compared to only 12% in the lifestyle-only group.
The trial also monitored improvements in metabolic comorbidities (obesity-related health issues such as dyslipidaemia or glucose intolerance). The findings were stark: 80% of participants in the ESG group saw improvements in their metabolic health, whereas 50% of the control group saw their conditions worsen over the same period.
Safety and Longitudinal Durability
Safety data from the 131 participants who eventually received the ESG procedure (including those who crossed over from the control group after 52 weeks) showed a low rate of complications. Serious adverse events (SAEs) occurred in 2% of the cohort, typically involving manageable issues like perigastric fluid collections (fluid buildup around the stomach), which did not require surgical intervention.
Durability is a frequent concern in obesity intervention. At the two-year mark, 68% of the participants maintained a significant portion of their weight loss (25% or more of their EWL), suggesting that the physiological changes induced by the suturing—which include altered gastric physiology (the way the stomach functions) and increased satiety (the feeling of fullness)—provide benefits when paired with lifestyle changes.
Evidence Strength: This multi-centre randomised controlled trial provides high-quality evidence with significant clinical outcomes and a clear safety profile for endoscopic interventions. Final Rating: ★★★★★
Source: Read the full study
