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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

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

92

Study population

Obesity / overweight, PCOS

Eligibility highlights

•Female

Primary endpoint

•Hepatic Glucose Release

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 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

Who this study enrolls

Obesity / overweightPCOS

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
3
Glycemic / diabetes
2
Other clinical outcomes
2
Cardiometabolic biomarkers
1

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

GroupMean · mg/kg/min95% CI
Control1.85-
PCOS Medication Naive1.46-
PCOS, Medication Naive + Byetta1.54-
PCOS on COCPs1.88-
PCOS on Metformin1.57-
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

GroupMean · dL/kg/min/μU/mL95% CI
Control0.000319383-
PCOS Medication Naive0.00021077-
PCOS, Medication Naive + Byetta0.00033516-
PCOS on COCPs0.00021791-
PCOS on Metformin0.0000959833333-

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

GroupMean · ratio over total phosphate95% CI
ControlPDE/TP0.167684728-
PME/TP0.067905319-
ATP/TP0.592517535-
Pi/TP0.041945761-
NADPH/TP0.097201285-
UDPG/TP0.032745372-
PCOS, Medication Naive + ByettaPDE/TP0.198640255-
PME/TP0.077949656-
ATP/TP0.566952309-
Pi/TP0.054581135-
NADPH/TP0.068550332-
UDPG/TP0.033326313-
PCOS on COCPsPDE/TP0.198787476-
PME/TP0.075872089-
ATP/TP0.565157308-
Pi/TP0.046604505-
NADPH/TP0.067305736-
UDPG/TP0.046272886-
PCOS on MetforminPDE/TP0.186923469-
PME/TP0.066789803-
ATP/TP0.557277652-
Pi/TP0.074459672-
NADPH/TP0.074693726-
UDPG/TP0.039855678-
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

GroupMean · percent fat95% CI
Control4.1-
PCOS Medication Naive7.6-
PCOS, Medication Naive + Byetta6.9-
PCOS on COCPs6.8-
PCOS on Metformin13.3-
Secondary/protocol endpoint

Hepatic de Novo Lipogenesis

Time frame:Measured up to 4 months from enrollment

change from baseline, improvement

Posted result

GroupMean · mg/dL95% CI
Control9.3-
PCOS Medication Naive6.6-
PCOS, Medication Naive + Byetta7.9-
PCOS on COCPs18.2-
PCOS on Metformin19.4-

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

GroupMean · mg/kg/min95% CI
Control0.54-
PCOS Medication Naive0.49-
PCOS, Medication Naive + Byetta0.49-
PCOS on COCPs0.78-
PCOS on Metformin0.65-

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

GroupMean · Apnea Hypopnea Index95% CI
Control9.15-
PCOS, Medication Naive + Byetta31.25-
PCOS on COCPs19.32-
PCOS on Metformin19-
Other/protocol endpoint

Sleep Duration

Time frame:Measured up to 4 months from enrollment

descriptive

Posted result

GroupMean · minutes95% CI
Control430.85-
PCOS Medication Naive437.88-
PCOS, Medication Naive + Byetta410.3-
PCOS on COCPs438.29-
PCOS on Metformin414.87-

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

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.