ObesityAUDACITYNCT05368259
The AUDACITY Study (AllUrion Device in Adults With Clinical ObesITY)
A study testing AGBS in people with Obesity, run by Allurion Technologies at 17 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- AGBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 17 sitesUnited States
- Study dates
- 12 May 2022to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 50Show fewer
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of Colorado, Anschutz Health and Wellness Center
Aurora, Colorado, 80045
UT Health Science Center at Houston
Bellaire, Texas, 77401
Tufts Medical Center
Boston, Massachusetts, 02111
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Atrium Health Care
Charlotte, North Carolina, 28204
Chicago Institue of Advanced Surgery
Chicago, Illinois, 60657
University of Miami, Miller School of Medicine
Doral, Florida, 33166
Indiana University
Indianapolis, Indiana, 46202
Saint Luke's Hospital Kansas City
Kansas City, Missouri, 64111
Cedars-Sinai
Los Angeles, California, 90048
Vanderbilt Center for Surgical Weight Loss
Nashville, Tennessee, 37204
Northwell Health
New Hyde Park, New York, 11004
University of Nebraska Medical Center
Omaha, Nebraska, 68106
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, 15213
Segar MD
San Antonio, Texas, 78258
HonorHealth Research Institute
Scottsdale, Arizona, 85258
Washington University
St Louis, Missouri, 63110
About this study
Official title: A Prospective, Open-Label, Multi-Center, Randomized, Pivotal Safety and Efficacy Study of the Allurion Gastric Balloon System + Moderate Intensity Lifestyle Modification Therapy Program vs. Moderate Intensity Lifestyle Modification Therapy Program for the Treatment of Adults With Obesity
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.
Read the detailed 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.
- Conditions
- Obesity
- Being tested
- AGBS
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGBSDevice
Also called Allurion Gastric Balloon System (AGBS)
The AGBS is designed to promote weight loss in individuals with obesity. The AGBS includes the Allurion Balloon, which is a temporary gastric balloon that promotes weight loss in individuals with obesity. The AGBS consists of up to 2 balloons placed during a 1-year period.
| Study group | Role | What they receive |
|---|---|---|
| AGBS + Moderate Intensity Lifestyle Therapy Group | Experimental | Patients randomized to treatment will receive the AGBS device Receives: Device: AGBS |
| Moderate Intensity Lifestyle Therapy (CONTROL) Group | No intervention | Patients randomized to the control arm will receive moderate-intensity lifestyle therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate (RR) dichotomized at 5% TBWL at 48 week
Responder Rate (RR) dichotomized at 5% TBWL at 48 weeks is significantly greater than 50%
Measured: 48 weeks
%TBWL is significantly greater than Control Group mean %TBWL at 48 weeks
%TBWL is significantly greater than Control Group mean %TBWL at 48 weeks, with a super superiority margin of 3.0%
Measured: 48 weeks
Secondary outcomes (1)
Responder Rate (RR) dichotomized at both 5% and 10% TBWL at both 16 and 24 weeks
Responder Rate (RR) dichotomized at both 5% and 10% TBWL at both 16 and 24 weeks: RR per treatment will be assessed using an exact binomial test and compared between treatments using a two-sided Fisher Exact test; p-values will be descriptive statistics.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start12 May 2022
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allurion Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368259
- Sponsor's protocol ID
- TRL-1000-0007
- Acronym
- AUDACITY
- Status last verified
- Oct 2024
- First submitted
- 6 May 2022
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Multi-Center, Randomized, Pivotal Safety and Efficacy Study of the Allurion Gastric Balloon System + Moderate Intensity Lifestyle Modification Therapy Program vs. Moderate Intensity Lifestyle Modification Therapy Program for the Treatment of Adults With Obesity
- ClinicalTrials.gov ID
- NCT05368259
- Acronym / sponsor ID
- AUDACITY / TRL-1000-0007
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Allurion TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 12 May 2022 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AGBS + Moderate Intensity Lifestyle Therapy Group | Experimental | Device: AGBSPatients randomized to treatment will receive the AGBS device |
| Moderate Intensity Lifestyle Therapy (CONTROL) Group | No intervention | –Patients randomized to the control arm will receive moderate-intensity lifestyle therapy. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (50 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGBSAlso: Allurion Gastric Balloon System (AGBS)The AGBS is designed to promote weight loss in individuals with obesity. The AGBS includes the Allurion Balloon, which is a temporary gastric balloon that promotes weight loss in individuals with obesity. The AGBS consists of up to 2 balloons placed during a 1-year period. | Device | AGBS + Moderate Intensity Lifestyle Therapy Group |
Primary outcome
Responder Rate (RR) dichotomized at 5% TBWL at 48 week
Time frame: 48 weeks
Responder Rate (RR) dichotomized at 5% TBWL at 48 weeks is significantly greater than 50%
%TBWL is significantly greater than Control Group mean %TBWL at 48 weeks
Time frame: 48 weeks
%TBWL is significantly greater than Control Group mean %TBWL at 48 weeks, with a super superiority margin of 3.0%
1 secondary outcome
Responder Rate (RR) dichotomized at both 5% and 10% TBWL at both 16 and 24 weeks
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AGBS in people with Obesity, run by Allurion Technologies at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 50 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder Rate (RR) dichotomized at 5% TBWL at 48 week (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.