Status:
RECRUITING
Effects of Glucagon-like Peptide-1 (GLP-1) Agonist in Neuro-reproductive Function in Obese Adolescent Females With Polycystic Ovary Syndrome (PCOS)
Lead Sponsor:
Nemours Children's Clinic
Conditions:
Polycystic Ovarian Syndrome in Adolescent Females
Obesity (Disorder)
Eligibility:
FEMALE
12-18 years
Brief Summary
The prevalence of childhood obesity in the United States has more than tripled in the past four decades affecting one in every five adolescent girls and is disproportionally higher among racial and/or...
Detailed Description
The prevalence of childhood obesity in the United States has more than tripled in the past four decades affecting one in every five adolescent girls and is disproportionally higher among racial and/or...
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.
Key Trial Info
Start Date :
September 11 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07169136
Start Date
September 11 2025
End Date
December 1 2026
Last Update
September 16 2025
Active Locations (1)
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1
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207