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GLP-1 Agonist for PCOS in Obese Adolescent Females

This observational study is looking at how a medication called Semaglutide, a GLP-1 receptor agonist, affects young women with Polycystic Ovary Syndrome (PCOS) and obesity. Researchers want to understand if Semaglutide can improve reproductive hormones like LH (luteinizing hormone), FSH (follicle-stimulating hormone), total testosterone, and estradiol. They will measure changes in these hormones after four months of using Semaglutide. The study is for females aged 12 to 18 who have been diagnosed with PCOS and obesity. The goal is to enroll 20 participants.

Study design
This is an observational study with 20 planned participants. It is not specified if it is randomized or blinded.
What's involved
Participants will have blood samples taken at the start of the study and again after four months of using Semaglutide weekly.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for four months after starting the intervention to measure changes in hormone levels.

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NCT07169136

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

Recruiting
Not specifiedAges 12–18Observational
Nemours Children's Clinic
~20 participants
Updated 2025-09-16 on ClinicalTrials.gov
What's tested:GLP-1 Receptor Agonists

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in LH pulse frequency after 4 months of GLP-1 agonist use.
Measured over Blood sampling will occur at study enrollment and then 4 months post intervention.
+4 more outcomes measured

Conditions

Polycystic Ovarian Syndrome in Adolescent Females
Obesity (Disorder)

Explore related trials

ObesityPolycystic Ovary Syndrome

Where it's being run

1 sites across 1 states
Florida1

Who to contact

Camila Pereira-Eshraghi, MD. MS.
[email protected]
1 + 904-408-7895
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in LH pulse frequency after 4 months of GLP-1 agonist use.Blood sampling will occur at study enrollment and then 4 months post intervention.

    LH will be obtained every 20 minutes overnight. LH will be measured using a chemiluminescence assay. Pulse frequency will be calculated using mathematical deconvolution analysis.

  • Change in average levels of LH and FSH after 4 months of GLP-1 agonist use.Blood sampling will occur at study enrollment and then 4 months post intervention.

    LH and FSH will be measured using a chemiluminescence assay.

  • Change in average levels of Total testosterone and Estradiol after 4 months of GLP-1 agonist use.Blood sampling will occur at study enrollment and then 4 months post intervention.

    Total testosterone and estradiol will be measured by liquid chromatography-mass spectrometry

  • Change in average levels of progesterone after 4 months of GLP-1 agonist use.Blood sampling will occur at study enrollment and then 4 months post intervention.

    Progesterone will be measured using immunoassay.

  • Change in LH amplitude.Blood sampling will occur at study enrollment and then 4 months post intervention.

    LH will be obtained every 20 minutes overnight. LH will be measured using a chemiluminescence assay. Pulse amplitude will be calculated using mathematical deconvolution analysis.