The AUDACITY Study (AllUrion Device in Adults With Clinical ObesITY)

Prospective, open-label, multi-center, randomized study comparing the AGBS + moderate intensity lifestyle modification therapy program vs. moderate intensity lifestyle modification therapy program for the treatment of adults with obesity.

Inclusion criteria

• Age ≥22 years and ≤ 65 years of age
• BMI ≥30 kg/m2 and ≤ 40 kg/m2
• Have signed study-specific Informed Consent Form
• Willing to comply with study requirements, including follow-up visits
• Documented negative pregnancy test in women of childbearing potential
• Women of childbearing potential not intending to become pregnant for the duration of study participation. (Note: Women of childbearing potential must not be nursing at the time of treatment).
• Fully ambulatory without any severe chronic orthopedic disease that requires reliance on crutches, walkers, or a wheelchair that could preclude exercise during the study
• At least one unsuccessful attempt at weight loss, such as self-administered, commercial, or medically supervised lifestyle therapy program attempted within the 24 months preceding enrollment

Exclusion criteria

• Unable to walk 400 meters (the length of one loop of a track and field race track) without the use of an assistance device (e.g. cane, crutches, walker, wheel chair)
• Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease
• Pre-existing significant respiratory disease such as chronic obstructive pulmonary disease (COPD), severe sleep apnea and pneumonia
• Previous bariatric surgery including adjustable gastric band and endoscopic sleeve gastroplasty, or likely to undergo bariatric surgery during the study period
• Previous use of an intragastric gastric balloon
• Current use of an intragastric device, PlenityTM and digital weight loss solutions (e.g. Noom or Calibrate)
• History of any cancer other than non-melanoma skin cancer or papillary thyroid cancer within the last 5 years
• Benign or malignant gastrointestinal tumors
• History of chronic pancreatitis or acute pancreatitis within 12 months of enrollment
• History of, or current, small bowel obstruction
• History of severe GI motility disorder, such as severe gastroparesis
• History of any esophageal, gastric, or small bowel surgery
• History of, or current inflammatory bowel disease
• Any history of intraperitoneal adhesions
• Any history of open abdominal or gynecological surgery and/or radiation therapy to the abdomen, with the exception of cesarean sections performed at least 12 months prior to study enrollment
• History of/or signs and symptoms of/or radiographic evidence of esophageal, gastric, or duodenal disease including, but not limited to hiatal hernia ≥5cm, inflammatory diseases, varices, severe gastroparesis, recent history of gastric or duodenal ulcers, stricture/stenosis, achalasia, severe GERD requiring maximal medical therapy, or LA Grade B, C, or D esophagitis
• Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma)
• Immunocompromised due to medications or medical disease or diagnosed with HIV
• History of genetic or endocrine causes of obesity not adequately controlled by medication, including hypothyroidism
• Type 1 diabetes or Type 2 diabetes with HgbA1c ≥ 7%, or treated with any anti-diabetic medications other than metformin
• Significant acute and/or chronic infections
• Severe coagulopathy defined as INR 1.5 or higher or platelet count <150, hepatic insufficiency, or cirrhosis
• Unable or unwilling to discontinue use of aspirin and/or nonsteroidal anti-inflammatory agents (NSAIDs) at least 7 days prior to Allurion Deployment and continuing for 7 days after the Allurion Balloon is excreted
• Currently taking the following medications (within 30 days prior to enrollment) and/or there is a need or anticipated need for these medications during the study: Excluded Medications Systemic corticosteroids Anticoagulant therapy (e.g., warfarin, dabigatran) or anti-platelet therapy Immunosuppressive therapy (e.g., azathioprine, cyclosporine) Narcotics, opiates, or benzodiazepines Insulin for treatment of diabetes Anti-seizure therapy (e.g., clonazepam, phenytoin) Anti-arrhythmics (e.g., amiodarone)
• Inability or unwillingness to take anti-emetics during the device residence
• Prescription or over-the- counter weight loss medication known to cause significant weight gain or weight loss within 90 days of study enrollment through study participation
• Uncontrolled or severe psychiatric disease other than mild depression with a patient health questionnaire score of 9 or below
• History of pulmonary embolism or deep venous thrombosis
• Has cardiac pacemaker or other electric implantable device
• Anemia defined as either:

Hgb <11 g/dL for females, <12 g/dL for males

• Cessation of any nicotine product within 3 months of enrollment or plans to quit use during the study
• Documented total body weight loss of ≥ 5% anytime 6 months preceding enrollment
• Residing in a location without access to study site medical resources
• History of or currently active eating disorders including night eating syndrome (NES), bulimia, or binge eating disorder
• Unwilling to refrain from any reconstructive and/or cosmetic surgery that may affect body weight during the study such as mammoplasty and lipoplasty
• Current, or history of, illicit drug use (defined per state law) or excessive alcohol use
• Enrolled in another investigational study that has not completed the required primary endpoint follow-up period (Note: Subjects involved in a long-term surveillance phase of another study are eligible for enrollment in this study).
• Current Use (within the last month) of any smoked or non-smoked marijuana products that contain THC or unwilling to abstain from THC containing marijuana products during the trial.
• Any conditions that, in the opinion of each site investigator, may render the subject unable to complete the study with a likely final outcome, or lead to difficulties for subject compliance with study requirements, or could confound study data.
• Subject is not of sufficient medical health as determined by the Investigator to participate in the study.
• Employees/family members of Allurion Technologies or any of its affiliates or contractors
• Immediate employees/family members of the Investigator, sub- Investigators, or their medical office or practice, or surgical, bariatric or hospital organizations at which study procedures may be performed
• An immediate family member (by marriage or blood relationship) of another subject already enrolled in the study
• Positive breath or stool test for H. Pylori
• History of covid-19 with any residual symptoms
• Known or suspected allergies to polyurethane
• Uncontrolled high blood pressure defined as ≥160/100 mmHg with or without medications
• Uncontrolled high cholesterol or triglycerides defined as LDL ≥190 mg/dL or triglycerides ≥500 mg/dL
• Inability to swallow Allurion Practice Capsule