Gastric Balloon for Obesity

(AUDACITY Trial)

Not currently recruiting at 20 trial locations

Overseen By Aurora Pryor, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Allurion Technologies

Must not be taking: Corticosteroids, Anticoagulants, Immunosuppressants, others

Disqualifiers: Heart failure, Respiratory disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness and safety of a gastric balloon device (AGBS) for weight loss when combined with lifestyle changes. Participants will receive either the balloon with lifestyle therapy or lifestyle therapy alone. The study aims to evaluate the balloon's effectiveness over 48 weeks and provide evidence for FDA approval. This trial may suit individuals with obesity (BMI 30–40) who have unsuccessfully tried other weight loss methods in the past two years. As an unphased trial, it offers participants a unique opportunity to contribute to groundbreaking research in weight loss solutions.

Do I need to stop my current medications for the trial?

Yes, you may need to stop certain medications. The trial requires participants to discontinue aspirin, NSAIDs, and several other medications like systemic corticosteroids, anticoagulants, and narcotics at least 7 days before the procedure and during the study.

What prior data suggests that the AGBS device is safe for obesity treatment?

Research shows that the AGBS, a type of gastric balloon for weight loss, is generally safe. Studies have found that this swallowable, gas-filled balloon effectively aids weight loss. These balloons are less invasive than surgery, offering a safer option for some patients.

One study found these balloons effective in managing obesity and related health issues. Another study with Korean patients reported a good safety record, indicating few serious side effects.

However, fluid-filled gastric balloons might lead to more weight loss but can be harder for some to tolerate. Gas-filled balloons, like the AGBS, usually have a better safety record. Overall, research suggests that AGBS is a well-tolerated choice for those seeking weight loss. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional obesity treatments that often involve medications or surgery, the AGBS (Adjustable Gastric Balloon System) offers a minimally invasive approach. This treatment involves placing a balloon in the stomach that can be adjusted to help control appetite and promote weight loss. Researchers are excited because it provides a non-surgical option that could be more appealing to patients who want to avoid the risks associated with surgery. Additionally, the ability to adjust the balloon offers a customizable and potentially more effective way to manage obesity compared to fixed treatments.

What evidence suggests that the AGBS device is effective for obesity?

Research has shown that the Adjustable Gastric Balloon System (AGBS), which participants in this trial may receive, can aid weight loss in people with obesity. One study found that participants lost an average of 12.9 kg in the first three months of using a similar gastric balloon. Another study reported a decrease in waist size by about 4.1 cm. Long-term results indicate that weight loss can be maintained for six to 60 months, with an average of 8.01 kg kept off. Additionally, participants experienced an 11.11% total body weight loss over a year. These findings suggest that the AGBS could be a promising option for managing weight. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

Adults aged 22-65 with a BMI between 30 and 40, who have tried and failed to lose weight in the past two years. Participants must be able to exercise without assistance devices, not pregnant or nursing, fully vaccinated against COVID-19, and willing to follow study procedures.

Inclusion Criteria

I have tried and failed to lose weight in the past 2 years.

BMI ≥30 kg/m2 and ≤ 40 kg/m2

Willing to comply with study requirements, including follow-up visits

Exclusion Criteria

I have not used marijuana products containing THC in the last month and am willing to abstain during the trial.

My cholesterol or triglycerides levels are not higher than the specified limits.

I have anemia with Hgb levels below the normal range.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the AGBS device and moderate intensity lifestyle modification therapy

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AGBS

Trial Overview The AUDACITY Study is testing the safety and effectiveness of AGBS (a device placed inside the stomach) combined with a moderate intensity lifestyle modification program over a period of 48 weeks in adults struggling with obesity.

How Is the Trial Designed?

Group I: AGBS + Moderate Intensity Lifestyle Therapy Group Experimental Treatment 1 Intervention

Patients randomized to treatment will receive the AGBS device

Group II: Moderate Intensity Lifestyle Therapy (CONTROL) Group Active Control 1 Intervention

Patients randomized to the control arm will receive moderate-intensity lifestyle therapy.

Who Is Running the Clinical Trial?

Allurion Technologies

Lead Sponsor

Trials

4

Recruited

1,500+

Published Research Related to This Trial

A review of FDA data from January 2017 to November 2020 identified 773 cases involving intragastric balloons, revealing a total of 1134 patient complications, primarily due to device leaks (33.4%).

The most common adverse events reported were vomiting (26.6%), abdominal pain (25.3%), and nausea (15.8%), indicating significant side effects that need to be managed to enhance the effectiveness of this obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Experience of Intragastric Balloons for Obesity: Insights from the FDA Manufacturer and User Facility Device Experience (MAUDE) Database. Ramai, D., Bhandari, P., Facciorusso, A., et al.[2021]

In a study of 190 obese patients undergoing gastric balloon therapy, the average weight loss was 21.2 kg after 6 months, indicating significant efficacy in promoting weight loss for morbidly obese individuals.

The procedure demonstrated a high safety profile, with only minor complications occurring in 2% of cases and no major complications or mortality, making it a viable option for initial obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative weight reduction using the intragastric balloon. Göttig, S., Weiner, RA., Daskalakis, M.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12354925/

Comparative Efficacy and Long-Term Outcomes of Intragastric ... Long-term outcomes revealed durable weight maintenance over six to 60 months (mean 8.01 kg, 95% CI 4.93-11.09; I² = 60.55%; BMI reduction: 4.96 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4917609/

Current status of intragastric balloon for obesity treatment - PMC The Orbera intragastric balloon was most effective during the first 3 mo of therapy. During that time, average weight loss of obese patients was 12.9 kg, or 80% ...

3. gastrojournal.org gastrojournal.org/article/S0016-5085(21)00477-7/fulltext

AGA Clinical Practice Guidelines on Intragastric Balloons ... Likewise, patients with obesity who used IGBs, on average, were able to reduce their waist circumference by 4.1 cm compared with patients who used noninvasive ...

4. link.springer.com link.springer.com/article/10.1007/s11695-023-06953-0

Safety and Efficacy of 12-Month Intra-gastric Balloon ... This equated to 11.11% total body weight loss (TBWL) (IQR 6.67–16.45%) or 36.58% excess BMI loss (IQR 21.05–56.50%) (Table 3). Of the entire ...

5. mdpi.com mdpi.com/2039-7283/14/3/61

Evaluating Weight Loss Efficacy in Obesity Treatment with ... This investigation confirms the hypothesis that Allurion's ingestible gastric balloon significantly reduces weight in the short term and enhances several ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10781818/

Safety and Efficacy of 12-Month Intra-gastric Balloon—Series ... The current study aimed to analyse the safety and efficacy of this 12-month IGB.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1550728918311018

Clinical safety and effectiveness of a swallowable gas-filled ... This swallowable gas-filled intragastric balloon system is safe and effective at inducing weight loss and offers physicians another tool for patients whose ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7939781/

The Clinical and Metabolic Effects of Intragastric Balloon ... IGB placement provides a minimally invasive, safe, and effective method for managing patients with obesity and related metabolic comorbidities.

9. e-ce.org e-ce.org/journal/view.php?number=7693

Efficacy and safety of intragastric balloon for obesity in Korea IGB treatment showed good efficacy and safety profile in Korean patients with obesity. In terms of %TBWL and percentage excess body weight ...