Allurion Publishes Landmark Peer-Reviewed Study Demonstrating Over 20% Total Body Weight Loss With Consecutive Use of Its Smart Capsule
Allurion Technologies, Inc. (NYSE: ALUR), a global leader in developing innovative, non-surgical weight-loss solutions, announced a major milestone in the field of metabolic health with the publication of the first peer-reviewed study investigating the consecutive use of the Allurion Smart Capsule. This swallowable, procedure-less weight-loss device—widely recognized as a transformative approach in obesity management—has now been shown to achieve weight-loss results comparable to those of bariatric surgery and high-dose GLP-1 therapies, according to findings published in Obesity Surgery, a top international journal focusing on obesity and metabolic diseases.
The newly published multicenter, retrospective study provides compelling evidence that two consecutive treatments with the Allurion Smart Capsule can result in an average total body weight loss (TBWL) of 22.1%, or approximately 19.3 kilograms, among overweight and obese adults. These results are not only clinically significant but also establish the Smart Capsule as a safe, effective, and scalable alternative for patients seeking substantial weight loss without surgery or long-term medication dependence.
Study Overview: Expanding the Boundaries of Non-Surgical Weight Loss
The study examined a cohort of 121 adult participants across 11 international clinical centers, including both overweight individuals (Body Mass Index [BMI] of 25–30) and patients with obesity (BMI of 30 or higher). Participants underwent two consecutive Smart Capsule treatments, each designed to last four months. Researchers evaluated total body weight loss, percentage changes in BMI, and safety outcomes over the treatment period.
Remarkably, no serious device-related adverse events were reported across the entire study population. This excellent safety profile reinforces the reliability of Allurion’s swallowable capsule as a repeatable, low-risk intervention.
Dr. Roberta Ienca, Senior Author of the study and a physician at Nuova Villa Claudia Clinic in Rome, Italy, underscored the significance of these results:
“This study provides robust evidence that consecutive use of the Allurion Smart Capsule is both safe and effective. What excites me most is that it shows patients can achieve weight loss of over 20% without surgery. Consecutive treatment broadens what is possible in obesity care, as a flexible, scalable tool that could meet the needs of patients at different stages of their weight-loss journey.”
Dr. Ienca’s statement highlights a key advantage of Allurion’s approach—the ability to tailor treatment intensity and duration based on individual patient needs. Unlike traditional surgical procedures or injectable medications, the Smart Capsule allows for stepwise interventions, making it especially suitable for patients hesitant or ineligible for invasive procedures.
Reinforcing Evidence From the AUDACITY Trial
The design of this study closely mirrors the structure of AUDACITY, Allurion’s pivotal FDA clinical trial evaluating the Smart Capsule as a potential first-line therapy for patients requiring more than 20% weight loss. The convergence of findings between these two studies strengthens the evidence base supporting the capsule’s use in clinical practice.
Earlier in 2025, Allurion submitted the fourth and final module of its Pre-Market Approval (PMA) application for the Smart Capsule to the U.S. Food and Drug Administration (FDA), signaling the company’s commitment to bringing this innovation to patients in the United States. The publication of this peer-reviewed research further validates Allurion’s technology and supports its regulatory and commercial strategy.
The Smart Capsule represents an entirely new category of weight management technology—a swallowable device that requires no surgery, endoscopy, or anesthesia. Once ingested, the capsule is filled with gas via a thin catheter, expanding into a soft balloon that occupies space in the stomach to induce satiety. After approximately four months, a time-activated release valve allows the balloon to naturally deflate and pass through the digestive system.
Setting a New Benchmark for Non-Surgical Weight Loss
For decades, bariatric surgery has been considered the most effective intervention for significant, sustained weight loss. However, surgical approaches come with inherent risks, high costs, and limited accessibility. Meanwhile, the recent surge in GLP-1 receptor agonists, such as semaglutide, has opened new therapeutic avenues—but these injectable medications often require lifelong administration and can be cost-prohibitive for many patients.
Against this backdrop, the Allurion Smart Capsule offers a third pathway—a non-invasive, temporary, yet highly effective method for achieving clinically meaningful weight loss. The consecutive-use study now positions this device as a viable alternative capable of matching or exceeding results from the most advanced pharmacological and surgical treatments available.
Dr. Shantanu Gaur, Founder and CEO of Allurion Technologies, emphasized the broader implications of this research:
“This is a milestone for Allurion, but more importantly, for patients. The data show that a non-surgical, swallowable device can deliver weight-loss outcomes once thought possible only with surgery or high-dose drugs. As we continue to build the evidence base, our goal is to redefine what is possible in non-surgical weight loss and set a new benchmark for innovation in the field.”
Dr. Gaur further noted that the findings represent a crucial step toward establishing a new standard of care—one that is both scalable and accessible to millions of people struggling with obesity worldwide. By expanding treatment options and bridging the gap between lifestyle interventions and invasive procedures, Allurion aims to empower both patients and clinicians with flexible, data-driven tools.
The Science Behind the Allurion Smart Capsul
The Allurion Smart Capsule’s innovation lies in its simplicity and integration with digital health tools. The capsule is designed to be swallowed during a brief outpatient visit, requiring no endoscopic assistance. Once inside the stomach, it is filled with gas through a thin catheter that is subsequently removed. The expanded capsule then occupies space in the stomach, promoting early satiety and reducing caloric intake.
After about four months, the capsule naturally empties and exits the body without medical intervention, minimizing patient downtime and discomfort.
This physical intervention is enhanced by Allurion’s Virtual Care Suite (VCS), a digital ecosystem that provides real-time behavioral support and remote monitoring throughout the treatment journey. Through connected scales, health apps, and telehealth check-ins, the VCS empowers patients to build sustainable habits and maintain their weight loss beyond the device’s lifespan.
Together, the Smart Capsule and the Virtual Care Suite form the Allurion Program—a comprehensive, end-to-end weight-loss experience that blends biomedical engineering, behavioral science, and digital health innovation.
A Step Toward Redefining Obesity Care
The publication of this study in Obesity Surgery marks more than just a scientific milestone—it signals a paradigm shift in how obesity can be managed. The consecutive use of the Allurion Smart Capsule challenges long-held assumptions that significant weight loss requires either surgical intervention or continuous pharmacotherapy. Instead, it points toward a modular, repeatable, and non-invasive pathway that fits seamlessly into a patient’s evolving health journey.
For patients, the implications are profound. The ability to safely undergo consecutive treatments provides flexibility in reaching personalized health goals, whether that means losing 10% or more than 20% of total body weight. For clinicians, this approach offers a new, evidence-based treatment strategy to expand obesity care beyond traditional limitations.
Allurion’s growing body of peer-reviewed research, coupled with its ongoing regulatory initiatives, reflects the company’s commitment to scientific rigor and patient safety. The company’s technology continues to demonstrate strong performance across diverse populations, geographies, and BMI categories—an essential factor as global obesity rates continue to climb.
With obesity affecting more than 1 billion people worldwide, there is an urgent need for safe, effective, and accessible interventions that can be deployed at scale. The Allurion Smart Capsule, supported by an expanding library of clinical evidence, stands poised to play a transformative role in addressing this public health crisis.
As Dr. Gaur summarized:
“Our mission is to democratize weight loss. By offering a simple, procedure-less solution supported by digital care, we are moving closer to making meaningful weight loss achievable for everyone—without the barriers of surgery or the burden of chronic medication.”
Through its continued innovation, clinical validation, and patient-centered approach, Allurion Technologies is not just introducing a new medical device—it is helping to reshape the future of obesity treatment and redefine what success looks like in metabolic health.
