Allurion’s Smart Capsule shows more than 20% weight loss

The first peer-reviewed study on the consecutive use of the Allurion’s Smart Capsule, a first of its kind, swallowable, procedure-less weight-loss device, has revealed the multi-centre, retrospective outcomes demonstrated that two consecutive treatments can achieve average total body weight loss of 22.1% (19.3 kg), results comparable to bariatric surgery and high-dose GLP-1 therapy.

The Allurion Smart Capsule is designed to be swallowed during a brief outpatient visit, filled once in the stomach, and pass naturally after four months. When combined with Allurion’s Virtual Care Suite, patients also receive digital support and remote monitoring aimed to change behaviours and improve outcomes. The goal of the study was to evaluate the safety and effectiveness of consecutive placements of the swallowable gastric balloon programme (SGBP) in adults with overweight and obesity.

The study included 121 overweight adults (BMI of 25 to 30) and adults with obesity (BMI of 30 and above) across 11 international sites. Data on weight loss (WL), total body weight loss (%TBWL) and adverse events were retrospectively collected on patients who received consecutive SGBs between March 2017 and November 2023. The first SGB was swallowed and filled with 550mL of distilled water in an outpatient setting. A second SGB was placed following passage of the first for additional weight loss. Lifestyle and nutritional follow-up were performed.

Baseline mean age, weight, and BMI were 43.6 ± 11.1 years, 102.6 ± 22 kg, and 36.4 ± 7.0 kg/m2, respectively. After passage of the first SGB at 4 months, mean WL and %TBWL were 14.0 ± 5.7 kg and 15.9 ± 5.7%, respectively. At the time of the second SGB placement, mean weight and BMI were 90.8 ± 20.2 kg and 32.0 ± 6.0 kg/m2 respectively, indicating an average weight gain of 2.1 ± 3.9 kg. The second SGB resulted in additional mean WL and %TBWL of 7.3 ± 5.3 kg and 9.3 ± 7.1%, with total WL and %TBWL from baseline to passage of the second SGB of 19.3 ± 8.9 kg and 22.1 ± 9.5%, respectively. No serious adverse events occurred.

“This study provides robust evidence that consecutive use of the Allurion Smart Capsule is both safe and effective,” said Dr Roberta Ienca, the Senior Author of the study and Medical Doctor at Nuova Villa Claudia Clinic in Rome, Italy. “What excites me most is that it shows patients can achieve weight loss of over 20% without surgery. Consecutive treatment broadens what is possible in obesity care, as a flexible, scalable tool that could meet the needs of patients at different stages of their weight-loss journey.”

The study design mirrors the approach used in AUDACITY, the company’s FDA pivotal study, reinforcing the potential of consecutive Smart Capsule use as a first-line therapy for higher BMI patients who require more than 20% weight loss but are unwilling or ineligible to undergo surgery. Based on the results of the AUDACITY trial, Allurion submitted the fourth and final module of the Pre-Market Approval application to the FDA earlier this year.

“This is a milestone for Allurion, but more importantly, for patients. The data show that a non-surgical, swallowable device can deliver weight-loss outcomes once thought possible only with surgery or high-dose drugs. As we continue to build the evidence base, our goal is to redefine what is possible in non-surgical weight loss and set a new benchmark for innovation in the field,” said Dr Shantanu Gaur, Founder and CEO of Allurion. “This is another step toward creating a new standard of care that we expect to be both scalable and accessible. By broadening the range of effective options, we seek to empower more patients and clinicians to find solutions that fit their needs and circumstances.”

The findings were reported in the paper, Multicenter Retrospective Analysis of Consecutive Swallowable Gastric Balloon Treatments in a Community Obesity Care Setting’, published in Obesity Surgery. To access this paper, please click here (log-in maybe required)