DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07169136

Recruiting

Effects of Glucagon-like Peptide-1 (GLP-1) Agonist in Neuro-reproductive Function in Obese Adolescent Females With Polycystic Ovary Syndrome (PCOS)

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

1

Recruiting sites

1

Enrollment

20

estimated

Study population

Obesity / overweight, PCOS

Key I/E criterion

•Female

Primary endpoints

•LH pulse frequency after 4 months of GLP-1 agonist use•Average levels of LH and FSH after 4 months of GLP-1 agonist use•Androgen, 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 IDNCT07169136
Org study ID25-014

Timeline

Milestones

Study first posted2025-09-11actual
Study start2025-09-11actual
Last update posted2025-09-16actual
Primary completion2026-12estimated (month precision)
Study completion2026-12estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-allSemaglutide

Study populations

Who this study enrolls

Obesity / overweightPCOS

Eligibility

Who can enroll

Minimum age12 Years
Maximum age18 Years
SexFemale
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Adolescent females with Obesity and PCOS.

Inclusion criteria

•Diagnosed with PCOS, by NIH criteria: oligomenorrhea (menstrual cycles <21 or >35 days) and hyperandrogenism (testosterone level or free androgen index (FAI) > refence range for tanner stage) and in good overall health
•Obesity (equal to or more than the 95th percentile)
•Females ages 12 to 18 years, at least 2 years post-menarche
•Participants has persistent symptoms of PCOS and obesity despite lifestyle modifications for at least 4 months.

Exclusion criteria

•Has abnormal thyroid function tests at Screening.
•Has suspected or known Diabetes mellitus, impaired fasting glucose, or elevated hemoglobin A1c.
•Has non-classic congenital adrenal hyperplasia.
•Has hyperprolactinemia.
•Has a known history or family history of medullary thyroid carcinoma or MEN2 and history of pancreatitis
•Participants receiving prior treatment with metformin, GLP-1 agonists, oral contraception pills, progesterone, or other insulin sensitizers for at least 6 weeks prior to Screening.
•Is currently pregnant or has been pregnant.

Endpoints (7)

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

Other clinical outcomes
5
Weight & body composition
1
Glycemic / diabetes
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Body composition will be measured by dual x-ray absorptiometry (DXA) scan.

Time frame:At enrollment and 4 months post intervention.

descriptive

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Carbohydrate metabolism and insulin sensitivity will be analyzed.

Time frame:Sampling will occur at enrollement and 4 months post intervention.

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other clinical outcomes

5 endpoints
Primary/protocol endpoint

Change in LH pulse frequency after 4 months of GLP-1 agonist use.

Time frame:Blood sampling will occur at study enrollment and then 4 months post intervention.

change from baseline, improvement

Primary/protocol endpoint

Change in average levels of LH and FSH after 4 months of GLP-1 agonist use.

Time frame:Blood sampling will occur at study enrollment and then 4 months post intervention.

change from baseline, improvement

Primary/protocol endpoint

Change in average levels of Total testosterone and Estradiol after 4 months of GLP-1 agonist use.

Time frame:Blood sampling will occur at study enrollment and then 4 months post intervention.

Androgen, change

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in average levels of progesterone after 4 months of GLP-1 agonist use.

Time frame:Blood sampling will occur at study enrollment and then 4 months post intervention.

Androgen, change

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in LH amplitude.

Time frame:Blood sampling will occur at study enrollment and then 4 months post intervention.

change from baseline, improvement

Publications (4)

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 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.