CompletedPhase 2Results posted

Enhancing Weight Loss Maintenance With GLP-1RA (BYDUREON™) in Adolescents With Severe Obesity

Lead sponsor

University of Minnesota

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

100

Study population

Obesity / overweight

Eligibility highlights

•Age 12-17

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 IDNCT02496611

Org study ID1505M72081

Timeline

Milestones

Study first posted2015-07-14estimated

Primary completion2020-08-14actual

Study completion2020-08-14actual

Last update posted2022-01-03actual

Results first posted2022-01-03actual

Study start2015-12 (month precision)

Assets

Investigational agents

Exenatide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age12 Years

Maximum age17 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•BMI ≥1.2 times the 95th percentile (based on sex and age) or BMI ≥35 kg/m2

•12-17 years old

Exclusion criteria

•Type 1 or 2 diabetes mellitus

•Previous (within 6 months) or current use of medication(s) prescribed primarily for weight loss (refer to appendix material for comprehensive list)

•If currently using weight altering drug(s) for non-obesity indication(s) (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months

•Previous bariatric surgery

•If currently using anti-hypertensive medication(s), lipid medication(s), and/or medication(s) to treat insulin resistance (refer to appendix material for comprehensive list), any change in drug(s) or dose within the previous 6 months

•If currently using CPAP/BIPAP (for sleep apnea), change in frequency of use or settings within the previous 6 months

•History of treatment with growth hormone

•Neurodevelopmental disorder severe enough to impair ability to comply with study protocol

•Clinical diagnosis of bipolar illness, schizophrenia, conduct disorder, and/or substance use/abuse

•Females: currently pregnant, planning to become pregnant, or unwilling to use 2 or more acceptable methods of contraception when engaging in sexual activity throughout the study

•Tobacco use

•Liver/renal dysfunction

•ALT or AST >2 times the upper limit of normal

•Bicarbonate <18 mmol/L

•Creatinine >1.2 mg/dL

•History of pancreatitis

•Personal- and/or family history of medullary thyroid carcinoma

•Personal- and/or family history of multiple endocrine neoplasia type 2

•Calcitonin level >50 ng/L

•Bulimia nervosa

•Neurological disorder

•Hypothalamic obesity

•Obesity associated with genetic disorder (monogenetic obesity)

•Hyperthyroidism or uncontrolled hypothyroidism

•History of suicide attempt

•History of suicidal ideation or self-harm within the past year

•History of cholelithiasis

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

Body Mass Index

Time frame:52 weeks

BMI, change

percent change from baseline, improvement

Posted result

Group	Mean · percentage (body mass index)	95% CI
Weight Loss Maintenance Without Pharmacotherapy	10.1	-
Weight Loss Maintenance With Pharmacotherapy	4.6	-

Publications (2)

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

Exenatide for weight-loss maintenance in adolescents with severe obesity: A randomized, placebo-controlled trial.
Obesity (Silver Spring, Md.)2022 May (month)PMID35403350doi:10.1002/oby.23395via clinicaltrials gov reference derived + pubmed nct search
Utility of Body Mass Index in Identifying Excess Adiposity in Youth Across the Obesity Spectrum.
The Journal of pediatrics2016 Oct (month)PMID27496270doi:10.1016/j.jpeds.2016.06.059via 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.