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NCT05368259 · ClinicalTrials.gov registry record · NA
The AUDACITY Study (AllUrion Device in Adults With Clinical ObesITY)
A NA study of Obesity, sponsored by Allurion Technologies.
- Active
- Registry status
- NA
- Development phase
- 1,000
- Enrollment target
- 17
- Study locations
NCT05368259: Active NA study of Obesity, sponsored by Allurion Technologies.
NCT05368259 is a NA study of Obesity that is active but no longer recruiting, run by Allurion Technologies. The registered enrollment target is 1,000 participants, above the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (22% higher). The trial reports 17 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05368259, a NA study of Obesity, is active but no longer recruiting, sponsored by Allurion Technologies.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 1,000 participants
- Enrollment target
- 17
- Study locations
Study 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.
Primary Outcome
Responder Rate (RR) dichotomized at 5% TBWL at 48 weeks is significantly greater than 50%
Conditions Studied
Interventions
- DEVICE AGBS
Study Locations (17)
Massachusetts
- Tufts Medical Center - Boston
- Lahey Hospital and Medical Center - Burlington
Missouri
- Saint Luke's Hospital Kansas City - Kansas City
- Washington University - St Louis
Texas
- UT Health Science Center at Houston - Bellaire
- Segar MD - San Antonio
Arizona
- HonorHealth Research Institute - Scottsdale
California
- Cedars-Sinai - Los Angeles
Colorado
- University of Colorado, Anschutz Health and Wellness Center - Aurora
Florida
- University of Miami, Miller School of Medicine - Doral
Illinois
- Chicago Institue of Advanced Surgery - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2022-05-12 |
| Est. Completion | 2025-03-01 |
| Phase | NA |
What the registry record for NCT05368259 still lists
NCT05368259 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (22% higher).
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which AGBS is the first listed.
NCT05368259 lists 17 locations in 14 states (Massachusetts, Missouri, Texas).
Frequently Asked Questions
What is clinical trial NCT05368259 about?
NCT05368259 is a clinical study titled "The AUDACITY Study (AllUrion Device in Adults With Clinical 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.
What is the current status of trial NCT05368259?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,000 participants. The study started on 2022-05-12. Estimated completion is 2025-03-01.
What conditions does trial NCT05368259 study?
This clinical trial studies the following conditions: Obesity.
What interventions are being tested in trial NCT05368259?
The interventions under investigation include: AGBS (DEVICE).
Who is sponsoring clinical trial NCT05368259?
This trial is sponsored by Allurion Technologies, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05368259 being conducted?
This trial has 17 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05368259's enrollment target sits among peer trials
1,000 73rd of 1053 higher than 978 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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