A140 a 6-Month Swallowable Balloon System Results in Sustainable Weight Loss at 1 Year

[A140] A 6-month Swallowable Balloon System Results in Sustainable Weight Loss at 1 Year: Results from a Prospective, Randomized Sham-Controlled Trial

Authors: Aurora D. Pryor, MD1; James Swain, MD2; George Woodman, MD3; Steven A. Edmundowicz, MD, FASGE4; Tarek Hassanein, MD, FACP, FACG, ACAG, FAASLD5; Vafa Shayani, MD6; John Fang, MD7; Mark Noar, MD, MPH8; George M. Eid, MD9; Wayne J. English, MD10; Nabil Tariq, MD, FACP, FACG, ACAG, FAASLD11; Michael Larsen, MD12; Sreenivasa S. Jonnalagadda, MD13; Dennis S. Riff, MD14; Jaime Ponce, MD15; Shelby A. Sullivan, MD16

Affiliations: Stony Brook University1Honor Health2Mid South Bariatrics3University of Colorado, Denver4

University of California, San Diego5Franciscian St. James Health6University of Utah7Mark D Noar and Assoc8

West Penn Allegheny Health System9Vanderbilt University10Methodist Hospital, Houston11Virginia Mason University12

St. Lukes Hospital of Kansas City13Anaheim Regional Medical Center14Dalton Surgical Group15

Washington University, St. Louis16

Presented Friday, Nov. 4, 2016

Background: The Obalon 6-Month Balloon System, three sequentially swallowed gas-filled balloons, plus moderate intensity lifestyle therapy demonstrated 1.9 times more weight loss than lifestyle therapy alone in a 6-month randomized sham controlled trial with 65% of patients achieving 5% or more total weight loss (%TWL). Weight loss at 12 months (6 months after device removal) is a potential indicator of weight loss maintenance after device removal.

Methods: This was a randomized sham controlled trial at 15 US centers including participants 22-64 years old with a BMI of 30 to 40 kg/m2. A 1:1 randomization to the treatment group or the sham group was implemented. The Study included two phases. Phase 1 (Blinded) requested subjects to swallow three capsules (balloon or sugar-filled sham) by week 12 using an identical procedure. Swallowing of capsules was done in a progressive manner to enhance intragastric balloon tolerability and stimulate weight loss over the full treatment period. Subjects who swallowed at least two capsules and completed 18 weeks of therapy were included in the per protocol (PP) analysis. All subjects underwent 25 minutes of lifestyle therapy administered by a blinded registered dietitian every 3 weeks. At Week 24, the blind was revealed and the Obalon balloons were removed endoscopically. The co-primary endpoints were: 1) the difference in mean %TWL between the treatment group and sham group is greater than 2.1%, and 2) a Responder Rate, defined as >=5% TWL, achieved in >=35% of participants. In Phase 2 (unblinded) the treatment group was followed for 6 months after removal where subjects continued with 25 minutes of lifestyle therapy administered by a registered dietitian every 3 weeks. The sham group was offered optional 6-month balloon therapy. Treatment group weight loss maintenance after balloon removal was calculated as %TWL and percent excess weight loss (%EWL) at 1 year.

Results: 387 subjects swallowed at least one device. 366 subjects were included in the per protocol analysis. 185 subjects received Obalon Balloon capsules (treatment group: age 42.8 ± 9.5yrs, BMI 35.2 ± 2.7 kg/m2) and 181 received sham capsules (sham group: age 42.7 ± 9.4yrs, BMI 35.5 ± 2.7 kg/m2). Least-square mean %TWL at 6 months (previously presented) was 6.9 ± 5.0% and 3.6 ± 5.0% in the treatment and sham groups for a difference of 3.3 %TWL (p=0.026). Treatment group %EWL at 6 months was 25.2 ± 19.2%. 171 Treatment Group subjects lost weight with therapy and completed Phase I, participated in the 6-month follow up (Phase 2), which is now completed. Figure 1 shows all data points collected on the 171 Treatment patients that participated in the 6-month follow-up phase. At 24 weeks and end of balloon therapy, mean %TWL was 7.6 ± 4.4% and %EWL was 28.0 ± 17.2%. All treatment group subjects have completed 1 year of therapy with %TWL of 6.8% ± 6.5% and %EWL of 24.7% ± 24.4%. No unanticipated device events and a single (0.3%) serious adverse device event occurred during the balloon period (gastric ulcer after protocol prohibited nonsteroidal anti-inflammatory drug use for outpatient knee replacement, managed conservatively). Non-serious adverse device events (mostly abdominal cramping and nausea) occurred in 90.8% of subjects; 99.6% were rated mild or moderate.

Conclusions: The significant weight loss achieved with the Obalon 6-Month Balloon System is maintained at 12 months. This combination of lifestyle modification and Obalon balloon therapy provides a low risk option with sustained weight loss for patients with obesity.