GLP-1 Peptide Atlas, by Delfa

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CompletedPhase NAResults posted

Effects of Exenatide on Overweight Adolescents With Prader-Willi Syndrome

Effects of Exenatide on Obesity and Appetite in Overweight Patients With Prader-Willi Syndrome

Lead sponsor

Children's Hospital Los Angeles

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Hypothalamic / syndromic obesity, Obesity / overweight

Key I/E criterion

—

Primary endpoints

•Body weight, absolute change (kg)•BMI, change•BMI SDS, 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 IDNCT01444898

Org study IDCCI 11-00227

Timeline

Milestones

Study first posted2011-10-03estimated

Last update posted2016-09-29estimated

Results first posted2016-09-29estimated

Study start2012-03 (month precision)

Primary completion2013-05actual (month precision)

Study completion2013-12actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Hypothalamic / syndromic obesityObesity / overweight

Eligibility

Who can enroll

Minimum age13 Years

Maximum age20 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of Prader Willi Syndrome confirmed by genetic testing (DNA methylation or FISH)

•Ages 13-20 years

•body mass index (BMI) > 85th percentile for age and gender

Exclusion criteria

•Is currently using or has previously used a glucagon-like peptide-1 (GLP-1) agonist

•History of pancreatitis, or renal failure

•History of familial pancreatitis

•Amylase, or lipase levels > 2.5 times the upper limit of normal any time in the previous 2 years

•Creatinine clearance < 30 mL/min

•Other syndromic diagnoses

•gastrointestinal (GI) or renal illness in the 1 month prior to entering study

•Inability to take study drug

•Pregnancy

•Initiation of growth hormone (GH), estrogen, or testosterone or change > 25% of dose/kg/day during the 6 months prior to starting study

•Non-English speaking

Endpoints (9)

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

Cardiometabolic biomarkers

Glycemic / diabetes

Patient-reported / QoL

Weight & body composition

3 endpoints

Primary/protocol endpoint

Change in Weight

Time frame:6 months

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Exenatide	-.5	—

p.07Mixed Models Analysis

Primary/protocol endpoint

% Change in Body Mass Index (BMI)

Time frame:6 months

BMI, change

percent change from baseline, improvement

Posted result

Group	Value (mean), % change in BMI	95% CI
Exenatide	1.3	—

p0.08Mixed Models Analysis

Primary/protocol endpoint

Change in BMI Z-Score

Time frame:6 months

BMI SDS, change

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	95% CI
Exenatide	.1	—

p.8Mixed Models Analysis

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Change in HbA1c (%)

Time frame:6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage	95% CI
Exenatide	-.3	—

p.04Mixed Models Analysis

Primary/protocol endpoint

Change in Insulin Levels

Time frame:6 months

change from baseline, improvement

Posted result

Group	Value (mean), u/U ml^-1	95% CI
Exenatide	3	—

p.8Mixed Models Analysis

Cardiometabolic biomarkers

3 endpoints

Primary/protocol endpoint

Change in Leptin

Time frame:6 months

Leptin, change

change from baseline, improvement

Posted result

Group	Value (mean), ng ml^-1	95% CI
Exenatide	-7.4	—

p.2Mixed Models Analysis

Primary/protocol endpoint

Change in Acy Ghr

Time frame:6 months

acyl ghrelin plasma

change from baseline, improvement

Posted result

Group	Value (mean), pg ml^-1	95% CI
Exenatide	263	—

p.2Mixed Models Analysis

Primary/protocol endpoint

Change in Pancreatic Peptide (PP)

Time frame:6 months

change from baseline, descriptive

Posted result

Group	Value (mean), pg ml^-1	95% CI
Exenatide	15	—

p.04Mixed Models Analysis

Patient-reported / QoL

1 endpoint

Primary/protocol endpoint

Appetite Scores

Time frame:6 months

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	95% CI
ExenatideTotal Appetite Score Baseline	32.2	—
Total Appetite Score 6 month	25.4	—
Behavior Score Baseline	14.5	—
Behavior Score 6 months	10.6	—
Drive Score Baseline	12.6	—
Drive Score 6 months	10.4	—
Severity Score Baseline	5.1	—
Severity Score 6 months	4.4	—

p.004Mixed Models Analysis

Publications (10)

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

Effects of exenatide on weight and appetite in overweight adolescents and young adults with Prader-Willi syndrome.
Pediatric obesity2017 Jun (month)PMID27071367doi:10.1111/ijpo.12131via CT.gov reference
Treating diabetes mellitus in Prader-Willi syndrome with Exenatide.
Diabetes research and clinical practice2011 Apr (month)PMID21227526doi:10.1016/j.diabres.2010.12.009via CT.gov background
Effects of exenatide and lifestyle modification on body weight and glucose tolerance in obese subjects with and without pre-diabetes.
Diabetes care2010 Jun (month)PMID20332357doi:10.2337/dc09-1203via CT.gov background
The role of gut hormones and the hypothalamus in appetite regulation.
Endocrine journal2010 (year)PMID20424341doi:10.1507/endocrj.k10e-077via CT.gov background
Exendin-4 potently decreases ghrelin levels in fasting rats.
Diabetes2007 Jan (month)PMID17192476doi:10.2337/db05-0996via CT.gov background
The hypothalamus, hormones, and hunger: alterations in human obesity and illness.
Progress in brain research2006 (year)PMID16876568doi:10.1016/S0079-6123(06)53003-1via CT.gov background
Correlation between fasting plasma ghrelin levels and age, body mass index (BMI), BMI percentiles, and 24-hour plasma ghrelin profiles in Prader-Willi syndrome.
The Journal of clinical endocrinology and metabolism2004 Aug (month)PMID15292322doi:10.1210/jc.2003-032137via CT.gov background
Prader-Willi syndrome: advances in genetics, pathophysiology and treatment.
Trends in endocrinology and metabolism: TEM2004 Jan-Feb (year)PMID14693421doi:10.1016/j.tem.2003.11.003via CT.gov background
Elevated plasma ghrelin levels in Prader Willi syndrome.
Nature medicine2002 Jul (month)PMID12091883doi:10.1038/nm0702-643via CT.gov background
Ghrelin enhances appetite and increases food intake in humans.
The Journal of clinical endocrinology and metabolism2001 Dec (month)PMID11739476doi:10.1210/jcem.86.12.8111via CT.gov background

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.