Background

Weight loss (WL) comparison of intragastric balloons (IGB) with lifestyle intervention (LI) has been assessed in three FDA-regulated clinical trials in which LI included basic nutritional education, not reflecting the full potential of either IGB or LI. This is the first prospectively collected, BMI-matched, intention to treat study comparing an intensive 52-week LI with (EGLI, N=79), or without (ILI, N=413) the Elipse IGB (Allurion Technologies, Inc.). ILI included a structured curriculum-based nutritional, exercise and behavior modification program. The Elipse is a swallowable, fluid-filled IGB that does not require endoscopy or anesthesia for either placement or removal. It remains in the stomach for 16 weeks and then deflates and passes naturally. EGLI and LI had similar mean initial BMI (36.2+5.4 vs 36.8+5.0) but mean age (43.0+10.8 vs. 48.3+12.4, p=.0033) and %females (68.4% vs. 85.9%, p=.0063) were different. %TBWL was greater at EGLI at 16- (N=51, 13.6+5.0 vs. N=179, 6.4+4.7, p<.0001), 24- (N=22, 13.3±4.7 vs. N=122, 6.4±6.4, p<.0001) and 52-week (N=11, 14.0±6.2 vs. N=41, 7.9±7.5, p=.0184) follow-up. %patients achieving 5% at 16, 24 and 52 weeks and 10%TBWL at 16- and 24 weeks was greater (p<.0001) at EGLI. Elipse was independently associated with greater %TBWL (p<.0001) in regression analysis controlling for age and gender. Attrition rates were significantly lower at EGLI at 16, 24 and 52 weeks (p<.0001).

Conclusions

Elipse is an independent and highly significant contributor of WL when added to a 52-week ILI. Elipse greatly improves the % of patients achieving a meaningful weight loss and patients’ adherence to ILI.