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APPLE

CompletedPhase 2, PHASE3Results posted

Liver and Fat Regulation in Overweight Adolescent Girls

Assessment of Hepatic Glucose and Fat Regulation in Overweight Adolescent Girls

Lead sponsor

University of Colorado, Denver

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, PCOS

Key I/E criterion

•Female

Primary endpoint

•Hepatic Glucose Release

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 IDNCT02157974

Org study ID14-0542

Secondary IDK23DK107871

Secondary IDUL1TR001082

Timeline

Milestones

Study first posted2014-06-06estimated

Last update posted2024-06-04actual

Results first posted2024-06-04actual

Study start2014-08actual (month precision)

Primary completion2022-12actual (month precision)

Study completion2022-12actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweightPCOS

Eligibility

Who can enroll

Minimum age12 Years

Maximum age21 Years

SexFemale

Healthy volunteersAccepted

Inclusion criteria

•Females

•2 years post-menarche

•BMI percentile >90%

Exclusion criteria

•Type 2 diabetes

•Anemia

•Liver disease

•Medications known to effect insulin sensitivity

•Cause of oligomenorrhea or hirsutism other than PCOS,

•>3 hours a week of moderate exercise.

Endpoints (8)

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

MASH / liver

Glycemic / diabetes

Other clinical outcomes

Cardiometabolic biomarkers

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Hepatic Glucose Release

Time frame:Measured up to 4 months from enrollment

change from baseline, improvement

Posted result

Group	Value (mean), mg/kg/min	95% CI
Control	1.85	—
PCOS Medication Naive	1.46	—
PCOS, Medication Naive + Byetta	1.54	—
PCOS on COCPs	1.88	—
PCOS on Metformin	1.57	—

Other/protocol endpoint

Whole Body Insulin Sensitivity

Time frame:Measured up to 4 months from enrollment

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Value (mean), dL/kg/min/μU/mL	95% CI
Control	0.000319383	—
PCOS Medication Naive	0.00021077	—
PCOS, Medication Naive + Byetta	0.00033516	—
PCOS on COCPs	0.00021791	—
PCOS on Metformin	0.0000959833333	—

MASH / liver

3 endpoints

Secondary/protocol endpoint/low confidence

Hepatic Phosphate Concentrations

Time frame:Measured up to 4 months from enrollment

ratio, descriptive

Posted result

Group	Value (mean), ratio over total phosphate	95% CI
ControlPDE/TP	0.167684728	—
PME/TP	0.067905319	—
ATP/TP	0.592517535	—
Pi/TP	0.041945761	—
NADPH/TP	0.097201285	—
UDPG/TP	0.032745372	—
PCOS, Medication Naive + ByettaPDE/TP	0.198640255	—
PME/TP	0.077949656	—
ATP/TP	0.566952309	—
Pi/TP	0.054581135	—
NADPH/TP	0.068550332	—
UDPG/TP	0.033326313	—
PCOS on COCPsPDE/TP	0.198787476	—
PME/TP	0.075872089	—
ATP/TP	0.565157308	—
Pi/TP	0.046604505	—
NADPH/TP	0.067305736	—
UDPG/TP	0.046272886	—
PCOS on MetforminPDE/TP	0.186923469	—
PME/TP	0.066789803	—
ATP/TP	0.557277652	—
Pi/TP	0.074459672	—
NADPH/TP	0.074693726	—
UDPG/TP	0.039855678	—

Secondary/protocol endpoint

Hepatic Fat Fraction

Time frame:Measured up to 4 months from enrollment

Liver fat content, change

change from baseline, improvement

Posted result

Group	Value (mean), percent fat	95% CI
Control	4.1	—
PCOS Medication Naive	7.6	—
PCOS, Medication Naive + Byetta	6.9	—
PCOS on COCPs	6.8	—
PCOS on Metformin	13.3	—

Secondary/protocol endpoint

Hepatic de Novo Lipogenesis

Time frame:Measured up to 4 months from enrollment

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
Control	9.3	—
PCOS Medication Naive	6.6	—
PCOS, Medication Naive + Byetta	7.9	—
PCOS on COCPs	18.2	—
PCOS on Metformin	19.4	—

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Rates of Lipolysis

Time frame:Measured up to 4 months from enrollment

change from baseline, descriptive

Posted result

Group	Value (mean), mg/kg/min	95% CI
Control	0.54	—
PCOS Medication Naive	0.49	—
PCOS, Medication Naive + Byetta	0.49	—
PCOS on COCPs	0.78	—
PCOS on Metformin	0.65	—

Other clinical outcomes

2 endpoints

Other/protocol endpoint

Sleep Quality

Time frame:Measured up to 4 months from enrollment

AHI, change

change from baseline, improvement

Posted result

Group	Value (mean), Apnea Hypopnea Index	95% CI
Control	9.15	—
PCOS, Medication Naive + Byetta	31.25	—
PCOS on COCPs	19.32	—
PCOS on Metformin	19	—

Other/protocol endpoint

Sleep Duration

Time frame:Measured up to 4 months from enrollment

descriptive

Posted result

Group	Value (mean), minutes	95% CI
Control	430.85	—
PCOS Medication Naive	437.88	—
PCOS, Medication Naive + Byetta	410.3	—
PCOS on COCPs	438.29	—
PCOS on Metformin	414.87	—

Publications (3)

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

Relative Skeletal Muscle Mass Is Associated With Hepatic Steatosis in Adolescents With Overweight and Obesity.
Pediatric obesity2026 Apr (month)PMID42014131doi:10.1111/ijpo.70108via clinicaltrials gov reference derived + pubmed nct search
Clinical prediction score of nonalcoholic fatty liver disease in adolescent girls with polycystic ovary syndrome (PCOS-HS index).
Clinical endocrinology2019 Oct (month)PMID31301251doi:10.1111/cen.14062via clinicaltrials gov reference derived + pubmed nct search
Morning Circadian Misalignment Is Associated With Insulin Resistance in Girls With Obesity and Polycystic Ovarian Syndrome.
The Journal of clinical endocrinology and metabolism2019 Aug 1PMID30888398doi:10.1210/jc.2018-02385via clinicaltrials gov reference derived + 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.