Allurion Technologies (ALUR) has revealed the topline outcomes from its AUDACITY FDA pivotal trial, focusing on the safety and effectiveness of the Allurion Balloon. This trial, being the first FDA pivotal trial on an intragastric balloon for weight loss to report primary outcomes beyond nine months, was conducted as an open-label, multicenter, randomized, controlled study. A total of 550 participants were divided equally into two groups: one receiving two cycles of the Allurion Balloon and the other undergoing moderate intensity lifestyle therapy.
The treatment group received their first Allurion Balloon at Week 0, which naturally passed around Week 16, followed by a second balloon at Week 24, passing around Week 40. The trial's co-primary endpoints were assessed at Week 48, focusing on the responder rate and the comparison of percent total body weight loss between the groups.
The AUDACITY trial successfully met its responder rate co-primary endpoint, with over 50% of Allurion Balloon subjects losing more than 5% of their total body weight at 48 weeks. However, it fell short of the pre-specified 3% superiority margin needed for the comparative co-primary endpoint, partly due to higher-than-expected weight loss in the control group. Notably, at 40 weeks, the mean difference in total body weight loss between groups exceeded the 3% superiority margin.
The trial also reported a low rate of serious adverse events among Allurion Balloon subjects, at 3.1%, marking the lowest in a pivotal FDA trial for a liquid-filled intragastric balloon aimed at weight loss. Following these results, Allurion plans to submit the final module of its Pre-Market Approval application to the FDA.
