CompletedPhase 2Results posted

Exenatide in Extreme Pediatric Obesity

Lead sponsor

University of Minnesota

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight

Eligibility highlights

Primary endpoint

•BMI, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. 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

Exenatide

Who this study enrolls

Obesity / overweight

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

Group	Mean · percentage of change in BMI	95% 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

The effect of glucagon-like peptide-1 receptor agonist therapy on body mass index in adolescents with severe obesity: a randomized, placebo-controlled, clinical trial.
JAMA pediatrics2013 Apr (month)PMID23380890doi:10.1001/jamapediatrics.2013.1045via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.