Allurion Completes AUDACITY Trial Enrollment for Highly Non-Invasive Weight Loss Balloon
Allurion Technologies, Inc. (NYSE: ALUR) announced the successful completion of patient enrollment in its pivotal AUDACITY trial, designed to support the U.S. Food and Drug Administration (FDA) approval of the innovative Allurion Balloon. The study was completed two months ahead of schedule. Given the 48 week follow up, data could now be available in late 2024 or early 2025 based upon the timeline provided on clinicaltrials.gov.
The AUDACITY trial, a randomized, pivotal controlled study, enrolled 550 patients across 17 sites. Dr. Shelby Sullivan, the Principal Investigator of the AUDACITY trial and Director of the Gastroenterology Metabolic and Bariatric Program at the University of Colorado School of Medicine, expressed her confidence in the appeal of the Allurion Balloon as the obesity epidemic continues to escalate in the United States.
This clinical trial will measures to assess the effectiveness of a treatment or intervention for weight loss. The primary outcome measures include evaluating the Responder Rate defined at 5% Total Body Weight Loss (TBWL) at 48 weeks, with the aim of achieving a significantly greater rate than 50% of participants. Additionally, the trial aims to determine if the percent total body weight loss is significantly greater than the control group mean at 48 weeks, with a margin of 3.0% for super superiority.
Other outcome measures include assessing the percent of patients with both 5% and 10% TBWL at both 16 and 24 weeks and comparing it with the control group. The study will also look at changes in Body Mass Index (BMI) at 24 and 48 weeks and changes in various metabolic parameters, including HbA1c, total cholesterol, HDL-C, LDL-C, triglycerides, and liver function tests (LFTs) at 48 weeks.
The company noted that interest in the Allurion Balloon was evident through the AUDACITY trial website, which received an impressive 78,106 unique visitors. Over half of these visitors, totaling 39,947 individuals, completed a pre-screen questionnaire, underscoring the demand for less invasive but effective weight loss solutions.
The Allurion Balloon is a new weight loss solution and is the world’s first and only swallowable, procedure-less gastric balloon. Designed to overcome limitations of legacy gastric balloons, it is ingested as a capsule and filled under the guidance of a healthcare provider without requiring surgery, endoscopy, or anesthesia. The entire placement procedure takes approximately 15 minutes during an outpatient visit. Four months later, the patented ReleaseValve™ opens, allowing the balloon to naturally empty and pass out of the body, eliminating the need for the patient to return to the doctor for removal. The devices has been used outside of the United States to treat over 130,000 patients. If approved, the device will compete with other non-invasive offerings such as the FDA approved Apollo Endosurgery (acquired by Boston Scientific) endoscopic sleeve gastroplasty procedure.