Allurion Announces Positive Topline Results From AUDACITY Trial
Allurion Technologies (NYSE: ALUR) announced positive topline results from its AUDACITY trial, evaluating the safety and efficacy of the Allurion Balloon. This pivotal FDA trial is the first to report primary outcomes beyond 9 months for an intragastric balloon for weight loss. The trial included 550 subjects randomized 1:1 to either two cycles of the Allurion Balloon or a control group receiving moderate intensity lifestyle therapy.
At 48 weeks, over 50% of Allurion Balloon subjects lost more than 5% of their total body weight (58%; p-value = 0.0089). The Allurion Balloon group exhibited a 3.77% mean difference in total body weight loss compared to the control group, with a 2.69% superiority margin, which was under the pre-specified 3% margin (p-value=0.1616). At 40 weeks, the mean difference was 4.22%, exceeding the 3% margin.
The trial reported a low 3.1% rate of serious adverse events, the lowest for a liquid-filled intragastric balloon in an FDA trial. The fourth and final module of the Pre-Market Approval application is planned for 2025.
Allurion Technologies (NYSE: ALUR) ha annunciato risultati positivi dal trial AUDACITY, che valuta la sicurezza e l'efficacia del Pallone Allurion. Questo trial cruciale approvato dalla FDA è il primo a riportare i risultati principali oltre i 9 mesi per un pallone intragastrico destinato alla perdita di peso. Il trial ha coinvolto 550 soggetti randomizzati 1:1 a ricevere due cicli del Pallone Allurion o un gruppo di controllo che ha seguito una terapia di stile di vita di intensità moderata.
Dopo 48 settimane, oltre il 50% dei soggetti con Pallone Allurion ha perso più del 5% del loro peso corporeo totale (58%; p-value = 0.0089). Il gruppo del Pallone Allurion ha mostrato una differenza media del 3.77% nella perdita di peso totale rispetto al gruppo di controllo, con un margine di superiorità del 2.69%, che era al di sotto del margine pre-specificato del 3% (p-value=0.1616). Dopo 40 settimane, la differenza media era del 4.22%, superando il margine del 3%.
Il trial ha riportato un basso tasso dello 3.1% di eventi avversi gravi, il più basso per un pallone intragastrico riempito di liquido in un trial FDA. Il quarto e ultimo modulo dell'application per l'approvazione pre-mercato è previsto per il 2025.
Allurion Technologies (NYSE: ALUR) anunció resultados positivos de su ensayo AUDACITY, que evalúa la seguridad y eficacia del globo Allurion. Este ensayo pivotal de la FDA es el primero en reportar resultados primarios más allá de los 9 meses para un globo intragástrico destinado a la pérdida de peso. El ensayo incluyó 550 sujetos aleatorizados 1:1 a recibir dos ciclos del globo Allurion o un grupo de control que recibió terapia de estilo de vida de intensidad moderada.
A las 48 semanas, más del 50% de los sujetos del globo Allurion perdió más del 5% de su peso corporal total (58%; p-valor = 0.0089). El grupo del globo Allurion mostró una diferencia media del 3.77% en la pérdida de peso total en comparación con el grupo de control, con un margen de superioridad de 2.69%, que estuvo por debajo del margen preespecificado del 3% (p-valor=0.1616). A las 40 semanas, la diferencia media fue del 4.22%, superando el margen del 3%.
El ensayo reportó una baja tasa del 3.1% de eventos adversos graves, la más baja para un globo intragástrico lleno de líquido en un ensayo de la FDA. Se planea que el cuarto y último módulo de la solicitud de aprobación previa al mercado se presente en 2025.
알루리온 테크놀로지스 (NYSE: ALUR)는 체중 감소를 위한 알루리온 풍선의 안전성과 효능을 평가한 AUDACITY 시험에서 긍정적인 주요 결과를 발표했습니다. 이 FDA 승인이 필요한 주요 시험은 체중 감소를 위한 위내 풍선에 대해 9개월 이상 기본 결과를 보고한 첫 번째 사례입니다. 이 시험에는 550명의 피험자가 1:1로 무작위 배정되어 두 사이클의 알루리온 풍선 또는 중강도의 생활습관 치료를 받는 대조군으로 나누어졌습니다.
48주 후, 알루리온 풍선 그룹의 50% 이상이 전체 체중의 5% 이상을 감소시켰습니다 (58%; p-값 = 0.0089). 알루리온 풍선 그룹은 대조군에 비해 체중 감소의 평균 차이가 3.77%였으며, 우월성 마진은 2.69%로 사전 지정된 3% 마진을 하회했습니다 (p-값=0.1616). 40주 후에는 평균 차이가 4.22%로 3% 마진을 초과했습니다.
이 시험은 심각한 부작용 발생률이 3.1%로 가장 낮았으며, 이는 FDA 시험에서 액체로 채워진 위내 풍선의 가장 낮은 비율입니다. 시장 출시 전 승인 신청서의 4번째이자 마지막 모듈이 2025년에 계획되어 있습니다.
Allurion Technologies (NYSE: ALUR) a annoncé des résultats positifs de son essai AUDACITY, évaluant la sécurité et l'efficacité du Ballon Allurion. Cet essai majeur de la FDA est le premier à rapporter des résultats primaires au-delà de 9 mois pour un ballon intragastrique destiné à la perte de poids. L'essai a inclus 550 sujets randomisés 1:1 soit recevant deux cycles du Ballon Allurion, soit un groupe de contrôle suivant une thérapie de mode de vie de modérée intensité.
À 48 semaines, plus de 50 % des sujets du Ballon Allurion ont perdu plus de 5 % de leur poids total (58 % ; p-valeur = 0.0089). Le groupe du Ballon Allurion a montré une différence moyenne de 3.77 % dans la perte de poids totale par rapport au groupe de contrôle, avec une marge de supériorité de 2.69 %, ce qui était en dessous de la marge pré-spécifiée de 3 % (p-valeur=0.1616). À 40 semaines, la différence moyenne était de 4.22 %, dépassant la marge de 3 %.
L'essai a rapporté un faible taux de 3.1 % d'événements indésirables graves, le plus bas pour un ballon intragastrique rempli de liquide dans un essai FDA. Le quatrième et dernier module de la demande d'approbation préalable à la mise sur le marché est prévu pour 2025.
Allurion Technologies (NYSE: ALUR) gab positive Spitzenresultate aus seiner AUDACITY-Studie bekannt, die die Sicherheit und Wirksamkeit des Allurion-Ballons bewertet. Diese entscheidende FDA-Studie ist die erste, die primäre Ergebnisse nach mehr als 9 Monaten für einen intragastralen Ballon zur Gewichtsreduktion berichtet. In die Studie wurden 550 Probanden randomisiert 1:1 entweder für zwei Zyklen des Allurion-Ballons oder eine Kontrollgruppe, die eine Therapie mit moderater Intensität im Lebensstil erhielt, eingeteilt.
Nach 48 Wochen hatten über 50% der Probanden mit Allurion-Ballon mehr als 5% ihres gesamten Körpergewichts verloren (58%; p-Wert = 0.0089). Die Allurion-Ballon-Gruppe wies eine durchschnittliche Differenz von 3.77% im gesamten Körpergewichtsverlust im Vergleich zur Kontrollgruppe auf, mit einer Überlegenheitsspanne von 2.69%, die unter der vorher festgelegten Spanne von 3% lag (p-Wert=0.1616). Nach 40 Wochen betrug die durchschnittliche Differenz 4.22% und überschritt damit die 3%-Spanne.
Die Studie berichtete von einer niedrigen Rate schwerwiegender unerwünschter Ereignisse von 3.1%, dem niedrigsten Wert für einen mit Flüssigkeit gefüllten intragastralen Ballon in einer FDA-Studie. Das vierte und letzte Modul des Antrags auf Marktzulassung ist für 2025 geplant.
- Over 50% of Allurion Balloon subjects lost more than 5% of their total body weight.
- The Allurion Balloon group showed a 3.77% mean difference in total body weight loss compared to the control group.
- Low rate of serious adverse events at 3.1%, the lowest for a liquid-filled intragastric balloon in an FDA trial.
- The 2.69% superiority margin was less than the pre-specified 3% needed to meet the comparative co-primary endpoint.
Insights
The AUDACITY trial results demonstrate compelling evidence for the Allurion Balloon's effectiveness in weight management. The 58% responder rate achieving >5% total body weight loss at 48 weeks surpassed the statistical threshold (p=0.0089), marking a significant clinical achievement. The 3.1% serious adverse event rate represents the lowest reported among liquid-filled intragastric balloons in FDA trials, establishing a favorable safety profile.
The trial's dual-balloon approach, with sequential placement at Week 0 and Week 24, showcased optimal results at Week 40 with a 4.22% superiority margin over controls. While the 48-week endpoint showed a 2.69% margin, falling short of the pre-specified 3% threshold, this was primarily influenced by unexpectedly strong control group performance rather than treatment inefficacy.
Real-world data from 150,000 patients outside the US demonstrates even more promising outcomes, with weight loss ranging from <percent>14%</percent> with single balloon to <percent>22%</percent> when combined with their AI-powered Virtual Care Suite - substantially exceeding the trial results.
This pivotal FDA trial represents a critical milestone for Allurion's market positioning and competitive stance. The positive results, particularly the safety profile and responder rate, strengthen the company's PMA submission prospects. In the $70 billion obesity treatment market, Allurion's balloon system offers a unique value proposition as a non-surgical, non-pharmaceutical intervention.
The timing is particularly strategic given the current landscape dominated by GLP-1 medications. Allurion's potential positioning as an alternative or complementary treatment could capture significant market share, especially considering the ongoing supply constraints and high costs associated with GLP-1s. The demonstrated safety profile and efficacy data, combined with the scalable AI-powered virtual care platform, present a compelling commercial opportunity.
At 48 weeks, Allurion Balloon subjects had a greater than
Low rate of serious adverse events supports favorable safety profile of the Allurion Balloon
Fourth and final module of PMA submission including AUDACITY trial data planned for 2025
The AUDACITY trial is an open-label, multicenter, randomized, controlled study and is the first FDA pivotal trial on an intragastric balloon for weight loss to report primary outcomes beyond 9 months. 550 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
The rate of serious adverse events in Allurion Balloon subjects in the AUDACITY trial was
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.
“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 and Director, Endoscopic Bariatric and Metabolic Program Center for Digestive Health at Dartmouth-Hitchcock Health and Lead Investigator of the AUDACITY trial. “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.”
“Data from the AUDACITY trial demonstrate the Allurion Balloon’s positive impact on weight loss and excellent safety record,” said Dr. Ram Chuttani, Chief Medical Officer and Founding Partner of Allurion. “We believe that the Allurion Balloon will be a novel and very useful therapy for people in
“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,” said Dr. Shantanu Gaur, Founder and CEO of Allurion. “Our real-world experience in over 150,000 patients outside
Additional data on the AUDACITY trial will be presented at upcoming medical meetings.
About Allurion
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
For more information about Allurion and the Allurion Virtual Care Suite, please visit www.allurion.com.
Allurion is a trademark of Allurion Technologies, Inc. in
Forward-Looking Statements
This press release may contain certain forward-looking statements within the meaning of the
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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.
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Hannah Lindberg
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Source: Allurion Technologies, Inc.
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