GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT01484873

CompletedPhase 2Results posted

Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor

Effects of Exenatide on Body Weight in Patients With Hypothalamic Obesity

Lead sponsor

Vanderbilt University Medical Center

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Hypothalamic / syndromic obesity, Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Body weight, absolute change (kg)

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 IDNCT01484873

Org study ID111185

Timeline

Milestones

Study first posted2011-12-02estimated

Results first posted2016-08-11estimated

Last update posted2017-03-03actual

Study start2012-06 (month precision)

Primary completion2015-03actual (month precision)

Study completion2015-03actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Hypothalamic / syndromic obesityObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age40 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age 18 to 40 years old

•History of craniopharyngioma or other lesion in the hypothalamic region

•Greater than 6 months post-treatment, including chemotherapy, surgery or radiation

•BMI >30 mg/m2

•Females must be post-menopausal, surgically sterile or using effective birth control for at least 12 weeks

Exclusion criteria

•HgbA1C >7%

•Use of diabetes medications other than metformin in the past 12 weeks, including exenatide

•Use of weight loss drugs or initiation of a weight loss program in past 3 months

•Impaired renal function or history of kidney transplant

•History of gall stones (unless s/p cholecystectomy), pancreatitis or alcoholism

•Personal or family history of medullary carcinoma of the thyroid or MEN type 2

•History of gastroparesis or other gastric motility problems as exenatide decreases gastric motility

•History of allergic reaction to exenatide or other medication components

•Other significant comorbidities other than pituitary deficiencies

•Currently prescribed warfarin (exenatide may alter warfarin metabolism)

•Pregnant or lactating females

•History of severe hypoglycemia (BG <60 and requiring assistance from another person)

Endpoints (5)

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.

Coverage by outcome category

Weight & body composition

Glycemic / diabetes

Patient-reported / QoL

Other clinical outcomes

Weight & body composition

2 endpoints

Primary/protocol endpoint

Body Weight (kg)

Time frame:baseline, 50 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Exenatide	-1.4	-2.2 – 4.9

Secondary/protocol endpoint/low confidence

Resting Energy Expenditure (Kcals Per Day)

Time frame:baseline, 50 weeks

change from baseline, descriptive

Posted result

Group	Value (mean), kcal/day	95% CI
Exenatide	-157.7	-766.1 – 450.6

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Insulin Secretion (Area Under the Curve)

Time frame:baseline, 50 weeks

C-peptide AUC

change from baseline, improvement

Posted result

Group	Value (mean), 120 min*uU/mL x	95% CI
Exenatide	-89.3	-5127 – 4948

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Visual Analogue Scales for Post-meal Satiety

Time frame:baseline, 50 weeks

change from baseline, improvement

Posted result

Group	Value (mean), mm	95% CI
Exenatide	-2.5	-19.7 – 14.7

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint/low confidence

Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life)

Time frame:baseline, 50 weeks

change from baseline, improvement

Posted result

Group	Value (mean), minutes	95% CI
Exenatide	12.9	-38.5 – 64.3

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

A 52-week pilot study of the effects of exenatide on body weight in patients with hypothalamic obesity.
Obesity (Silver Spring, Md.)2016 Jun (month)PMID27133664doi:10.1002/oby.21493via CT.gov reference + pubmed nct search

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.