NCT03233048: IGB

Intragastric Balloon in Obese Adolescents With Comorbidities

Completed NA Results posted Last updated 3 May 2022

What this trial tests

NA trial testing ORBERA™ Intragastric Balloon in Obesity in 5 participants. Completed in 1 December 2020.

Timeline

26 October 2017

Primary endpoint
1 December 2020

1 December 2020

Quick facts

Lead sponsor	Imad Absah
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	26 October 2017
Primary completion	1 December 2020
Estimated completion	1 December 2020
Sites	1 location across United States

Drugs / interventions tested

• ORBERA™ Intragastric Balloon

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

Imad Absah

Who can join

Adults 14 to 17, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects Achieving Greater Than or Equal to 10% Total Body Weight Loss Primary · up to 1 year

Weight loss will be measured by change in weight divided by baseline weight.

Group	Value	95% CI
ORBERA™ Intragastric Balloon	2

Change in Alanine Aminotransferase (ALT) Secondary · Baseline, end of study (approximately 1 year)

Change will be measured as a percentage by taking change in ALT divided by baseline ALT.

Group	Value	95% CI
ORBERA™ Intragastric Balloon	25.7	± 36

Change in Aspartate Aminotransferase (AST) Secondary · Baseline, end of study (approximately 1 year)

Change will be measured as a percentage by taking change in AST divided by baseline AST.

Group	Value	95% CI
ORBERA™ Intragastric Balloon	11.5	± 12

Change in Fasting Insulin Secondary · Baseline, end of study (approximately 1 year)

Change will be measured as a percentage by taking change in fasting insulin divided by baseline fasting insulin.

Group	Value	95% CI
ORBERA™ Intragastric Balloon	33	± 57.5

Change in Hemoglobin A1c (HgA1c) Secondary · Baseline, end of study (approximately 1 year)

Change will be measured as a percentage by taking change in HgA1c divided by baseline HgA1c.

Group	Value	95% CI
ORBERA™ Intragastric Balloon	0.5	± 0.3

Change in High-density Lipoprotein (HDL) Secondary · Baseline, end of study (approximately 1 year)

Change will be measured as a percentage by taking change in HDL divided by baseline HDL.

Group	Value	95% CI
ORBERA™ Intragastric Balloon	23.4	± 31

Change in Low-density Lipoprotein (LDL) Secondary · Baseline, end of study (approximately 1 year)

Change will be measured as a percentage by taking change in LDL divided by baseline LDL.

Group	Value	95% CI
ORBERA™ Intragastric Balloon	9	± 19

Change in Triglycerides Secondary · Baseline, end of study (approximately 1 year)

Change will be measured as a percentage by taking change in triglycerides divided by baseline triglycerides.

Group	Value	95% CI
ORBERA™ Intragastric Balloon	28	± 22

Number of Participants With One or More Serious Adverse Events Secondary · Intragastric balloon (IGB) removal (approximately 6 months)

Number of participants to experience one or more serious adverse events as defined as Grade 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) scale.

Group	Value	95% CI
ORBERA™ Intragastric Balloon	0

Number of Subjects Who Had the Balloon Removed Early Secondary · Intragastric balloon (IGB) removal (approximately 6 months)

Early will be defined as balloon removal prior to the 6 month window time point as defined in the protocol.

Group	Value	95% CI
ORBERA™ Intragastric Balloon	1

Number of Subjects Whose Balloon Deflated Early Secondary · Intragastric balloon (IGB) removal (approximately 6 months)

Early will be defined as balloon deflation prior to the 6 month window time point as defined in the protocol.

Group	Value	95% CI
ORBERA™ Intragastric Balloon	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from baseline to end of study participation for a total of approximately 12 months on all participants. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ORBERA™ Intragastric Balloon

Serious: 0/5 (0%)

Deaths: 0/5

Other adverse events (3 terms — click to expand)

Reaction	System	ORBERA™ Intragastric Balloon
Abdominal pain/discomfort	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—

Data from ClinicalTrials.gov NCT03233048 adverse events section.

Sponsor's own description

The reason we are doing this research is to get information about the ORBERA™ Intragastric Balloon to learn if it is safe and if it works. We want to learn if older teenagers who are overweight will lose weight and if their other medical problems will get better. ORBERA™ is a special balloon approved by the FDA for overweight adults, and we would like to try using it for overweight teenagers.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Adolescents with Type 2 Diabetes: Overcoming Barriers to Effective Weight Management.
   Salama M, Biggs BK, Creo A, Prissel R, et al · · 2023 · cited 5× · PMID 36923685 · DOI 10.2147/dmso.s365829