Allurion Technologies Touts Positive Study Results for its Weight Loss Balloon

Patients receiving Allurion Technologies Inc.’s intragastric balloon lost more weight compared to study control subjects, according to AUDACITY trial results.

The U.S. Food and Drug Administration (FDA)-approved AUDACITY trial is an open-label, multicenter, randomized, controlled study evaluating the safety and efficacy of the Allurion Balloon. It is the first FDA pivotal trial on an intragastric balloon for weight loss to report primary outcomes beyond nine months, according to the company.

“Data from the AUDACITY trial demonstrate the Allurion Balloon’s positive impact on weight loss and excellent safety record,” Allurion Founding Partner/Chief Medical Officer Dr. Ram Chuttani stated. “We believe the Allurion Balloon will be a novel and very useful therapy for people in the United States living with obesity.”

Five hundred and fifty subjects were randomized 1:1 to either two cycles of the Allurion Balloon¹ or a control group that received moderate intensity lifestyle therapy. Subjects in the treatment group received their first Allurion Balloon at Week 0, which passes at approximately Week 16, and a second Allurion Balloon at Week 24, which passes at approximately Week 40. Co-primary endpoints based on Allurion Balloon subject responders and a comparison of percent total body weight loss between groups were measured at Week 48, approximately eight weeks after the second Allurion Balloon passes at Week 40.

The AUDACITY trial achieved its responder rate co-primary endpoint by demonstrating that more than 50% of Allurion Balloon subjects lost more than 5% of their total body weight at 48 weeks (58%; p-value = 0.0089). At 48 weeks, Allurion Balloon subjects exhibited substantially greater weight loss compared to control subjects with a 3.77% mean difference in total body weight loss, resulting in a 2.69% superiority margin. This margin was less than the pre-specified 3% superiority margin needed to meet the comparative co-primary endpoint (p-value=0.1616) and was impacted, in part, by higher-than-expected weight loss in control subjects. At 40 weeks, approximately when the second Allurion Balloon has passed, the 4.22% mean difference in total body weight loss between groups exceeded a 3% superiority margin.

“I believe the results of the AUDACITY trial demonstrate a favorable benefit-risk profile for people with obesity,” said Dr. Shelby Sullivan, professor of Medicine; director, Endoscopic Bariatric and Metabolic Program Center for Digestive Health at Dartmouth-Hitchcock Health; and AUDACITY trial lead investigator. “If approved, the Allurion Balloon could fill a significant gap in the treatment of obesity and serve as a valuable alternative to GLP-1 medications.”

The rate of serious adverse events in Allurion Balloon subjects in the AUDACITY trial was 3.1%, the lowest reported in a pivotal FDA trial for a liquid-filled intragastric balloon indicated for weight loss.²

Based on the results of the AUDACITY trial, Allurion plans to submit the fourth and final module of the Pre-Market Approval (PMA) application to the FDA.

“We were pleased with the performance of the Allurion Balloon subjects in the AUDACITY trial, where a majority of them were responders while using the balloon alone, without the customized digital platform that normally accompanies it commercially,” Allurion Founder/CEO Dr. Shantanu Gaur commented. “Our real-world experience in over 150,000 patients outside the United States shows that weight loss, exceeding that observed in AUDACITY, ranges from 14% with a single balloon cycle and up to 22% with two balloon cycles when the Allurion Balloon is combined with the AI-powered Virtual Care Suite.^3,4 The AUDACITY trial results further bolster this rich data set on the safety and efficacy of the Allurion Balloon. We are looking forward to submitting these data to the FDA and advancing our PMA application toward FDA approval.”

Additional data on the AUDACITY trial will be presented at upcoming medical meetings.

Allurion is dedicated to ending obesity. The Allurion Program is a weight loss platform that features the Allurion Gastric Balloon, the world’s first and only swallowable, Procedure-less intragastric balloon for weight loss, and offers access to the Allurion Virtual Care Suite, including the Allurion Mobile App for consumers, Allurion Insights for health care providers featuring the Coach Iris AI Platform, and the Allurion Connected Scale. The Allurion Virtual Care Suite is also available to providers separately from the Allurion Program to help customize, monitor and manage weight loss therapy for patients regardless of their treatment plan: gastric balloon, surgical, medical or nutritional. The Allurion Gastric Balloon is an investigational device in the United States.

References
¹ Subjects received only the Allurion Balloon without the Allurion App, Bluetooth® Scale, Coach Iris, or access to the Virtual Care Suite.
² The Allurion Balloon has not been compared to other liquid-filled intragastric balloons in a head-to-head study for weight loss or for frequency or type of adverse events.
³ Ienca et al. Obesity Surgery. 2020 Sep;30(9):3354-3362.
⁴ Ienca R, et al. Sequential Elipse Balloon Treatment 1 Year Weight Loss Results Approximate Bariatric Surgery Results, 2020.