Could a weekly shot fix hormone chaos in teens with PCOS?
NCT ID NCT07169136
First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 2 times
Summary
This study tests whether a weekly injection of semaglutide (a GLP-1 drug used for obesity) can improve the brain's reproductive hormone signals in obese adolescent girls with polycystic ovary syndrome (PCOS). Twenty girls aged 12–18 will receive the drug plus lifestyle advice for 16 weeks. Researchers will measure changes in overnight hormone pulses and body composition to see if the treatment helps restore normal reproductive function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Semaglutide (a GLP-1 receptor agonist, given as a weekly injection)
- What this could lead to
- If it works, this could point toward a treatment that helps restore normal menstrual cycles and hormone balance in obese adolescents with PCOS.
- What could go wrong
- This is a very small, early-phase study with only 20 participants, so results may not apply widely. The drug may not improve hormone rhythms, and side effects like nausea or vomiting are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adolescent females with Obesity and PCOS.
- Ages
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12 to 18 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Nemours Children's Clinic
RECRUITINGJacksonville, Florida, 32207, United States
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