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

Allurion

Status

Active, not recruiting

Conditions

Obesity

Treatments

Device: AGBS

Study type

Interventional

Funder types

Industry

Identifiers

NCT05368259

TRL-1000-0007

Details and patient eligibility

About

The objective for this clinical study is to provide FDA with clinical evidence regarding the effectiveness and safety of the AGBS + moderate intensity lifestyle modification therapy program, indwell time of the AGBS inside the stomach, and outcomes at 48 weeks.

Full description

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

22 to 65 years old

Volunteers

Accepts Healthy Volunteers

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