AUDACITY Trial Enrollment Ends

Allurion Technologies Inc. has completed patient enrollment in its AUDACITY study, a randomized, pivotal controlled trial designed to support U.S. Food and Drug Administration (FDA) approval of the Allurion Balloon. The trial enrolled 550 patients at 17 sites and completed enrollment ahead of schedule.
 
“I believe the brisk enrollment in the AUDACITY trial reflects the broad appeal of a novel, completely reversible weight loss device,” said Shelby Sullivan, M.D., director of the Gastroenterology Metabolic and Bariatric Program at the University of Colorado School of Medicine and principal AUDACITY trial investigator. “As the obesity epidemic worsens in the United States, I expect options like the Allurion Balloon will be attractive to a large segment of the population.”
 
The AUDACITY trial website received 78,106 unique visitors, of whom more than half (39,947) completed a pre-screen questionnaire.
 
“We were pleased to see such ahigh level of interest in the Allurion Balloon in the United States,” Allurion Vice President of Clinical Affairs Jay Donosky stated. “As interest in weight loss grows in the United States with the rise of GLP-1 drug therapy, we believe our robust enrollment is indicative of a strong desire for alternative first-line options.”
 
The Allurion Balloon is the world’s first and only swallowable, procedure-less gastric balloon for weight loss and was designed to address various shortcomings of legacy gastric balloons. It is swallowed as a capsule and filled under the guidance of a healthcare provider without surgery, endoscopy, or anesthesia. The placement takes approximately 15 minutes during an outpatient visit. Approximately four months later, a patented ReleaseValve opens, allowing the balloon to empty and pass out of the body naturally. The patient does not need to return to the doctor to have the balloon removed.
 
“We are delighted to bring the Allurion Balloon one step closer to commercialization in the United States,” Allurion Chief Medical Officer Dr. Ram Chuttani added. “We are looking forward to building off the experience we have acquired in treating over 130,000 patients outside of the United States.”
 
The Allurion Program is a weight-loss platform that combines the Allurion Gastric Balloon, the world’s first and only swallowable, procedure-less gastric balloon for weight loss, the Allurion Virtual Care Suite, including the Allurion Mobile App for consumers, Allurion Insights for healthcare providers featuring the Iris AI Platform, and the Allurion Connected Scale and Health Tracker devices. 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, whether it is gastric balloon, surgical, medical or nutritional. The Allurion Gastric Balloon is an investigational device in the United States.