← Trials/Trial dossier/NCT01061775

CompletedPhase 1, PHASE2Results posted

Effects of Exenatide on Hypothalamic Obesity

Asset

Exenatide

GLP-1 agonist

Listed sites

2

Recruiting sites

Enrollment

19

actual

Study population

Hypothalamic / syndromic obesity, Obesity / overweight

Key I/E criterion

Primary endpoints

BMI, changeWaist to Height Ratio (WHtR)

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 IDNCT01061775
Org study ID0903-028

Timeline

Milestones

Study first posted2010-02-03estimated
Results first posted2016-03-21estimated
Study completion2019-03-15actual
Last update posted2019-10-08actual
Study start2010-01 (month precision)
Primary completion2013-07actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Hypothalamic / syndromic obesityObesity / overweight

Eligibility

Who can enroll

Minimum age10 Years
Maximum age21 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

>/=6 months post surgical or radiation or chemotherapy treatment for 1° craniopharyngiomas or other suprasellar tumors
10-21 years old
Age-and sex-adjusted BMI >/=95%
Parent sign consent and patient sign assent

Exclusion criteria

< 6 months post surgical or radiation or chemotherapy treatment for 1° craniopharyngiomas or other suprasellar tumors
Pregnant or breastfeeding, or those women who plan to get pregnant
Renal impairment
Gastroparesis
Pancreatitis
Diabetes
<1 month post initiation of Metformin treatment
Prescription or over-the-counter weight loss medications within 3 months of screening
Are actively participating in, or have participated in a formal weight loss program within the last 3 months
Have had bariatric surgery

Endpoints (4)

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
2
Patient-reported / QoL
1
Other clinical outcomes
1

Weight & body composition

2 endpoints
Primary/protocol endpoint

BMI Change

Time frame:24 weeks

BMI, change

change from baseline, improvement

Posted result

GroupValue (mean), kg/m^295% CI
Exenatide-0.77-1.97 – 0.43
p.05t-test, 2 sided
Primary/protocol endpoint

Waist to Height Ratio (WHtR)

Time frame:24 weeks

ratio, improvement

Posted result

GroupValue (mean), percentage95% CI
Exenatide-2.06
p0.05t-test, 2 sided

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Childhood Eating Behavior Questionnaire (CEBQ)

Time frame:24 weeks

change from baseline, improvement

Posted result

GroupValue (mean), units on a scale95% CI
Exenatide1412.2167 – 15.7833
p0.05t-test, 2 sided

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Calorie Intake Based on 3-day Diet Records

Time frame:24 weeks

change from baseline, improvement

Posted result

GroupValue (mean), kcals95% CI
Exenatide406.700-117.088 – 930.488
p0.05t-test, 2 sided

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.