GLP-1 medication effects on reproductive hormones in obese teenage girls with PCOS
Official title: Effects of Glucagon-like Peptide-1 (GLP-1) Agonist in Neuro-reproductive Function in Obese Adolescent Females With Polycystic Ovary Syndrome (PCOS)
Run by Nemours Children's Clinic · NCT07169136 · Data updated 2026-11-12
We will test whether GLP-1 medications are linked to changes in reproductive hormones and menstrual cycles in obese adolescent girls with PCOS.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 12 Years to 18 Years |
| Sex | Women only |
| Enrollment | 20 (estimated) |
| Sponsor | Nemours Children's Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Status | Recruiting |
| Started | September 11, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | September 18, 2026 |
| Trial ID | NCT07169136 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Obese (≥95th percentile) female adolescents aged 12–18 years, at least two years post-menarche, diagnosed with PCOS by NIH criteria and still symptomatic despite lifestyle modifications are ideal candidates.
✕Probably not a fit
Patients with diabetes or impaired glucose tolerance, abnormal thyroid function, non-classic congenital adrenal hyperplasia, hyperprolactinemia, a personal or family history of medullary thyroid carcinoma/MEN2, pancreatitis, or recent use of metformin, GLP-1 agonists, hormonal contraception, progesterone, or other insulin sensitizers are unlikely to be eligible or to gain benefit from this observational analysis.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will enroll obese adolescent females with PCOS to examine relationships between GLP-1 receptor agonist exposure and neuro-reproductive function. Researchers will collect clinical histories, menstrual cycle data, metabolic measures, and blood samples to measure gonadotropin and sex steroid levels and to characterize GnRH/gonadotropin pulsatility. The study will also examine insulin and other metabolic markers and compare hormonal patterns in participants with and without GLP-1 agonist exposure. Work will be conducted at Nemours Children’s Clinic in Jacksonville and focuses on adolescents at least two years post-menarche who remain symptomatic despite lifestyle changes.
Why it matters
Potential benefit: If successful, this could point to GLP-1–based approaches that improve menstrual regularity and reproductive hormone balance in obese adolescents with PCOS.
How similar studies have gone: GLP-1 receptor agonists are proven for diabetes and weight loss and some adult studies show metabolic and reproductive improvements, but direct effects on neuro-reproductive function in adolescents with PCOS remain under-studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
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. * Diabetes mellitus * 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 GLP-1 agonists, oral contraception pills or progesterone for at least 6 weeks prior to Screening. * Is currently pregnant or has been pregnant.
Where it's running
-
Nemours Children's Clinic
Jacksonville, Florida, United States Recruiting
Study contacts
- Study coordinator: Camila Pereira-Eshraghi, MD. MS.
- Email: camila.pereira-eshraghi@nemours.org
- Phone: 1 + 904-408-7895
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.