Allurion Smart Capsule combined with lifestyle intervention improves weight loss and body composition

A case-controlled study on the use of the Allurion Smart Capsule combined with lifestyle intervention (LI) compared to LI alone, has found a significantly higher weight reduction, fat mass loss, and visceral fat loss in patients treated with the Allurion Smart Capsule combined with lifestyle intervention. At 36 weeks, Allurion Smart Capsule patients had an average weight reduction of 20% with favourable body composition changes.

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.

In this case-controlled study, a total of 1,143 patients with a BMI ≥ 30 kg/m2 participated in a 36-week LI. Of these, 267 received the Allurion Smart Capsule (LI +  Allurion Smart Capsule group), while 876 underwent the LI alone (LI group). The LI protocol featured personalized nutritional plans with daily protein intake goals, exercise goals, and regular telehealth follow-ups. The Allurion Smart Capsule was ingested without endoscopy or anaesthesia and passed naturally approximately 16 weeks post-placement. Body composition was assessed using bioimpedance at multiple time points.

The groups were age-matched but differed in sex and BMI. At 16 weeks, the LI + Allurion Smart Capsule group demonstrated significantly higher mean %TBWL (16.11 ± 5.06 vs. 10.22 ± 6.09, p<0.001), %FML (27.64 ± 9.78 vs. 15.34 ± 10.37, p<0.001), and %VFL (17.60 ± 7.33 vs. 13.80 ± 8.57, p<0.001). While % muscle mass loss was also higher in the LI + Allurion Smart Capsule group (6.57 ± 7.64 vs. 3.55 ± 12.45, p<0.001), the rate of %FML was more than double the rate of % muscle mass loss in both groups, suggesting favourable body composition changes. A significantly greater proportion of patients in the LI + Allurion Smart Capsule group achieved key weight loss thresholds of > 5%, > 10%, and > 20% TBWL at 16 weeks (all p<0.001).

"This study underscores the synergistic effects of the Allurion Smart Capsule with an individualized lifestyle intervention, with average weight reduction of 20% and nearly twice as much fat reduction at 36 weeks without adverse effects on muscle mass," said Dr Yannis Raftopoulos, Director of the Weight Management Program at Holyoke Medical Center and Principal Investigator. "This study demonstrated a safety profile better than bariatric surgery and GLP-1 therapy and an efficacy comparable to bariatric surgery and better than real-world, high-dose GLP-1 therapy at a substantially lower cost. This approach has the potential to set a new benchmark in obesity management not only by achieving significant weight loss but also by improving body composition - something not previously reported."

Overall, the study’s researchers found that Allurion Smart Capsule significantly enhanced total body weight loss, fat loss and visceral fat loss when used as an adjunct to an intensive lifestyle intervention. While the Allurion Smart Capsule did lead to greater muscle mass loss, the overall body composition changes were favourable, with fat loss far outpacing muscle loss in both intervention groups. These findings suggest that the Allurion Smart Capsule is a safe and effective tool to accelerate early weight loss, particularly fat loss, when combined with a robust lifestyle protocol.

“With over 30 peer-reviewed publications on the Allurion Smart Capsule, we believe there is little doubt that it has a unique value proposition for patients with obesity,” said Dr Shantanu Gaur, Founder and CEO of Allurion. “This publication demonstrates that using an individualized lifestyle intervention program in conjunction with the Allurion Smart Capsule can lead to significant weight loss with clear improvements in body composition, something patients who undergo bariatric surgery or high-dose GLP-1 therapy struggle to achieve.”

The findings were featured in the paper, ‘Exploratory Machine Learning Methods to Assess a Novel Individualized Lifestyle Intervention on Weight and Body Composition with or Without a Swallowable Intragastric Balloon’, published in Obesity Surgery. To access this paper, please click here (log-in maybe required)