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

NCT05368259 | Active Not Recruiting DMC FDA Device

• 1 other identifier: TRL-1000-0007
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• 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%

  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%

  48 weeks

Secondary Outcomes (1)

• Responder Rate (RR) dichotomized at both 5% and 10% TBWL at both 16 and 24 weeks

  48 weeks

Other Outcomes (3)

• RR dichotomized at 10% TBWL at both 40 and 48 weeks

  48 Weeks

• Change in body fatness as measured by Body Mass Index (BMI) at 24 and 48 weeks

  48 Weeks

• Change in metabolic parameters

  48 Weeks

Study Arms (2)

AGBS + Moderate Intensity Lifestyle Therapy Group

EXPERIMENTAL

Patients randomized to treatment will receive the AGBS device

Device: AGBS

Moderate Intensity Lifestyle Therapy (CONTROL) Group

NO INTERVENTION

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

Interventions

AGBS DEVICE

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.

Also known as: Allurion Gastric Balloon System (AGBS)

AGBS + Moderate Intensity Lifestyle Therapy Group

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allurion Technologies: lead

Study Sites (17)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

Cedars-Sinai

Los Angeles, California, 90048, United States

Location

University of Colorado, Anschutz Health and Wellness Center

Aurora, Colorado, 80045, United States

Location

University of Miami, Miller School of Medicine

Doral, Florida, 33166, United States

Location

Chicago Institue of Advanced Surgery

Chicago, Illinois, 60657, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Saint Luke's Hospital Kansas City

Kansas City, Missouri, 64111, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68106, United States

Location

Northwell Health

New Hyde Park, New York, 11004, United States

Location

Atrium Health Care

Charlotte, North Carolina, 28204, United States

Location

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt Center for Surgical Weight Loss

Nashville, Tennessee, 37204, United States

Location

UT Health Science Center at Houston

Bellaire, Texas, 77401, United States

Location

Segar MD

San Antonio, Texas, 78258, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 10, 2022
• Study Start: May 12, 2022
• Primary Completion: November 1, 2024
• Study Completion: March 1, 2025
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

US (17)