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CompletedPhase 2Results posted

Exenatide in Extreme Pediatric Obesity

Asset

Exenatide

GLP-1 agonist

Listed sites

2

Recruiting sites

Enrollment

26

actual

Study population

Obesity / overweight

Key I/E criterion

Primary endpoint

BMI, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01237197
Org study ID1009M88952

Timeline

Milestones

Study first posted2010-11-09estimated
Last update posted2014-09-12estimated
Results first posted2014-09-12estimated
Study start2010-10 (month precision)
Primary completion2012-05actual (month precision)
Study completion2012-10actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age12 Years
Maximum age19 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Body mass index > or = 1.2 times the 95th percentile (based on gender and age) or Body mass index > or = 35 kg/m2
12-19 years old

Exclusion criteria

Type 1 or 2 diabetes mellitus
Previous (within 3-months) or current use of weight loss medication (patients may undergo washout)
Previous bariatric surgery
Recent initiation (within 1-month) of anti-hypertensive or lipid medication
Previous (within 1-month) or current use of medication to treat insulin resistance or hyperglycemia (patients may undergo washout)
Major psychiatric disorder
Pregnant or planning to become pregnant
Tobacco use
Liver/renal dysfunction
History of pancreatitis
Obesity associated with genetic disorder
Hyperthyroidism or uncontrolled hypothyroidism
Uncontrolled hypertriglyceridemia (=300 mg/dL)
Current eating disorder
Previous (within 3-months) or current use of drugs associated with weight gain (e.g. steroids/anti-psychotics)

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Weight & body composition

1 endpoint
Primary/protocol endpoint

Percent Change From Baseline in Body Mass Index at 3-months

Time frame:Baseline and 3-months

BMI, change

percent change from baseline, improvement

Posted result

GroupValue (mean), percentage of change in BMI95% CI
Exenatide-2.9-5.02 – -0.37
Placebo Injection-0.15

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.