Polycystic Ovarian Syndrome in Adolescent FemalesNCT07169136
Effects of Glucagon-like Peptide-1 (GLP-1) Agonist in Neuro-reproductive Function in Obese Adolescent Females With Polycystic Ovary Syndrome (PCOS)
An observational study of Polycystic Ovarian Syndrome in Adolescent Females and Obesity (Disorder), run by Nemours Children's Clinic at 1 site in United States.
Trial 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 ethnic minorities. Read more about this study
- Who is it for?
- Ages 12 to 18 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome in Adolescent Females, Obesity (Disorder)
- What is being tested?
- GLP-1 Receptor Agonists
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Adolescent females with Obesity and PCOS.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nemours Children's Clinic
Jacksonville, Florida, 32207
Camila Pereira-Eshraghi, MD. MS., 1 + 904-408-7895, camila.pereira-eshraghi@nemours.org
About this study
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 ethnic minorities. Normal puberty onset and progression is dependent on normal hypothalamic-pituitary-gonadal (HPG) axis which is affected by whole body metabolism. Gonadotropin-releasing hormone (GnRH) and gonadotropins, LH and FSH, are released in a pulsatile manner for appropriate sex steroids production and gonadal function. Proper pulsatility in the GnRH system is disrupted by a significant change in energy balance such as in obesity. Polycystic Ovary Syndrome (PCOS) is the most common neuroendocrine dysfunction in women of reproductive age. Glucagon-like peptide-1 (GL-1), a peptide hormone secreted by the intestinal enteroendocrine L-cells following glucose and fat intake, stimulates insulin release by the pancreas in response to glucose, decreases gastric emptying and inhibits glucagon secretion. GLP-1 receptors are present in the hypothalamic nuclei and pituitary gland; and it is thought that GLP-1 may directly stimulate GnRH secretion and partially regulate reproduction. In animal studies, GLP-1 was found to stimulate GnRH secretion, to regulate kisspeptin (Kiss-1) mRNA and GnRH mRAN expression. GLP-1 receptor agonists are FDA-approved to treat adults and adolescents with obesity. Although the impact of GLP-1 receptor agonists in reproductive health has been investigated in preclinical trials, and in men with obesity and functional hypogonadism, no studies to date have investigated the impact of GLP-1 receptor agonists in female neuroendocrine function, particularly in youth. The goal of this proposal is to gather critical preliminary data to investigate, in a group of obese adolescent females with PCOS, the impact of GLP-1 agonist administration in addition to lifestyle modifications on the neuroendocrine rhythms - LH frequency and amplitude (principal); body composition, adiposity; and carbohydrate metabolism and insulin sensitivity. To accomplish these aims, we will recruit a cohort of up to 20 adolescents ages 12-18 years, at least 2 years post-menarche, with obesity, PCOS, by NIH criteria, without carbohydrate intolerance and in otherwise good health. Research volunteers will be advised on lifestyle modifications of diet and exercise as per routine, and a GLP-1 agonist will be started according to the product's label as per FDA guidelines in children with obesity. Medication will be titrated to maximal therapeutic dose, as per routine clinical practice. Participants will be treated for a total of 16 weeks. Neuroendocrine rhythms pre- and post-treatment will be compared.
Read the 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 ethnic minorities. Normal puberty onset and progression is dependent on normal hypothalamic-pituitary-gonadal (HPG) axis which is affected by whole body metabolism. Gonadotropin-releasing hormone (GnRH) and gonadotropins, LH and FSH, are released in a pulsatile manner for appropriate sex steroids production and gonadal function. Proper pulsatility in the GnRH system is disrupted by a significant change in energy balance such as in obesity. Polycystic Ovary Syndrome (PCOS) is the most common neuroendocrine dysfunction in women of reproductive age.
Glucagon-like peptide-1 (GL-1), a peptide hormone secreted by the intestinal enteroendocrine L-cells following glucose and fat intake, stimulates insulin release by the pancreas in response to glucose, decreases gastric emptying and inhibits glucagon secretion. GLP-1 receptors are present in the hypothalamic nuclei and pituitary gland; and it is thought that GLP-1 may directly stimulate GnRH secretion and partially regulate reproduction. In animal studies, GLP-1 was found to stimulate GnRH secretion, to regulate kisspeptin (Kiss-1) mRNA and GnRH mRAN expression. GLP-1 receptor agonists are established diabetes drugs that are also promising anti-obesity drugs and are FDA-approved to treat adults and adolescents with obesity. Although the impact of GLP-1 receptor agonists in reproductive health has been investigated in preclinical trials, and in men with obesity and functional hypogonadism, no studies to date have investigated the impact of GLP-1 receptor agonists in female neuroendocrine function, particularly in youth.
The goal of this proposal is to gather critical preliminary data to investigate, in a group of obese adolescent females with oligomenorrhea due to PCOS, the impact of GLP-1 agonist administration in addition to lifestyle modifications on -
Aim 1. neuroendocrine rhythms - LH frequency and amplitude (principal); Aim 2. body composition; Aim 3. carbohydrate metabolism and insulin sensitivity. The investigators hypothesize that 16 weeks intervention with a GLP-1 agonist will result in improvement of gonadotropin release patterns.
To accomplish these aims, the investigators will recruit a cohort of up to 20 adolescents ages 12-18 years, at least 2 years post-menarche, with obesity (BMI-for-age equal to or more than the 95th percentile), with PCOS, by NIH criteria: oligomenorrhea and hyperandrogenism (testosterone level or free androgen index > refence range for tanner stage.), in otherwise good health. Research volunteers will be advised on lifestyle modifications of diet and exercise as per routine, and a GLP-1 agonist will be started according to the product's label as per FDA guidelines in children with obesity. Medication will be titrated to maximal therapeutic dose, as per routine clinical practice, and continued for a total of 16 weeks.
Principal Study Outcomes
- Reproductive measures will include change in: LH pulse frequency and amplitude, average levels of LH and FSH, and estradiol, total testosterone
- Body composition will be measured by dual x-ray absorptiometry (DXA) scan
- Carbohydrate metabolism and insulin sensitivity will be measured by HOMA-IR (using fasting insulin and glucose levels).
- Being tested
- GLP-1 Receptor Agonists
- Keywords
- PCOS, Obesity, Adolescent Female, irregular menstrual cycles
- Medical subject headings
- Obesity, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 Receptor AgonistsDrug
Weekly subcutaneous Semaglutide.
| Study group | Role | What they receive |
|---|---|---|
| Females ages 12 to 18 years, at least 2 years post-menarche, with obesity and PCOS.. | Females ages 12 to 18 years, at least 2 years post-menarche, with obesity (BMI equal to or more than the 95th percentile for age) and with PCOS, by NIH criteria: oligomenorrhea (menstrual cycles <21 or >35 days) [4] and hyperandrogenism (testosterone level or free androgen index (FAI) > refence range for tanner stage) and in good overall health. FAI is calculated as total testosterone*100/sex hormone binding globulin. Receives: Drug: GLP-1 Receptor Agonists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LH pulse frequency after 4 months of GLP-1 agonist use.
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.
Measured: Blood sampling will occur at study enrollment and then 4 months post intervention.
Change in average levels of LH and FSH after 4 months of GLP-1 agonist use.
LH and FSH will be measured using a chemiluminescence assay.
Measured: Blood sampling will occur at study enrollment and then 4 months post intervention.
Change in average levels of Total testosterone and Estradiol after 4 months of GLP-1 agonist use.
Total testosterone and estradiol will be measured by liquid chromatography-mass spectrometry
Measured: Blood sampling will occur at study enrollment and then 4 months post intervention.
Change in average levels of progesterone after 4 months of GLP-1 agonist use.
Progesterone will be measured using immunoassay.
Measured: Blood sampling will occur at study enrollment and then 4 months post intervention.
Change in LH amplitude.
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.
Measured: Blood sampling will occur at study enrollment and then 4 months post intervention.
Secondary outcomes (2)
Body composition will be measured by dual x-ray absorptiometry (DXA) scan.
Body composition will be measured by DEXA (Hologic Discovery A)
Measured: At enrollment and 4 months post intervention.
Carbohydrate metabolism and insulin sensitivity will be analyzed.
Carbohydrate metabolism and insulin sensitivity will be measured by HOMA-IR (using fasting insulin and glucose levels).
Measured: Sampling will occur at enrollement and 4 months post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start11 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovarian Syndrome in Adolescent FemalesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camila Pereira-Eshraghi, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169136
- Sponsor's protocol ID
- 25-014
- Status last verified
- Sep 2025
- First submitted
- 19 Aug 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD captured during the study trial will be shared deidentified.
Publications
McCartney CR, Campbell RE. Abnormal GnRH Pulsatility in Polycystic Ovary Syndrome: Recent Insights. Curr Opin Endocr Metab Res. 2020 Jun;12:78-84. doi: 10.1016/j.coemr.2020.04.005. Epub 2020 Apr 23.
PubMed 32676541Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.
PubMed 3899825Ruffing KM, Koltun KJ, De Souza MJ, Williams NI. Moderate Weight Loss is associated with Reductions in LH Pulse Frequency and Increases in 24-hour Cortisol with no change in Perceived Stress in Young Ovulatory Women. Physiol Behav. 2022 Oct 1;254:113885. doi: 10.1016/j.physbeh.2022.113885. Epub 2022 Jun 16.
PubMed 35718216McCartney CR, Prendergast KA, Blank SK, Helm KD, Chhabra S, Marshall JC. Maturation of luteinizing hormone (gonadotropin-releasing hormone) secretion across puberty: evidence for altered regulation in obese peripubertal girls. J Clin Endocrinol Metab. 2009 Jan;94(1):56-66. doi: 10.1210/jc.2008-1252. Epub 2008 Oct 28.
PubMed 18957503
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Glucagon-like Peptide-1 (GLP-1) Agonist in Neuro-reproductive Function in Obese Adolescent Females With Polycystic Ovary Syndrome (PCOS)
- ClinicalTrials.gov ID
- NCT07169136
- Acronym / sponsor ID
- 25-014
- Keywords
- PCOS, Obesity, Adolescent Female, irregular menstrual cycles
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ethnic minorities. Normal puberty onset and progression is dependent on normal hypothalamic-pituitary-gonadal (HPG) axis which is affected by whole body metabolism. Gonadotropin-releasing hormone (GnRH) and gonadotropins, LH and FSH, are released in a pulsatile manner for appropriate sex steroids production and gonadal function. Proper pulsatility in the GnRH system is disrupted by a significant change in energy balance such as in obesity. Polycystic Ovary Syndrome (PCOS) is the most common neuroendocrine dysfunction in women of reproductive age. Glucagon-like peptide-1 (GL-1), a peptide hormone secreted by the intestinal enteroendocrine L-cells following glucose and fat intake, stimulates insulin release by the pancreas in response to glucose, decreases gastric emptying and inhibits glucagon secretion. GLP-1 receptors are present in the hypothalamic nuclei and pituitary gland; and it is thought that GLP-1 may directly stimulate GnRH secretion and partially regulate reproduction. In animal studies, GLP-1 was found to stimulate GnRH secretion, to regulate kisspeptin (Kiss-1) mRNA and GnRH mRAN expression. GLP-1 receptor agonists are FDA-approved to treat adults and adolescents with obesity. Although the impact of GLP-1 receptor agonists in reproductive health has been investigated in preclinical trials, and in men with obesity and functional hypogonadism, no studies to date have investigated the impact of GLP-1 receptor agonists in female neuroendocrine function, particularly in youth. The goal of this proposal is to gather critical preliminary data to investigate, in a group of obese adolescent females with PCOS, the impact of GLP-1 agonist administration in addition to lifestyle modifications on the neuroendocrine rhythms - LH frequency and amplitude (principal); body composition, adiposity; and carbohydrate metabolism and insulin sensitivity. To accomplish these aims, we will recruit a cohort of up to 20 adolescents ages 12-18 years, at least 2 years post-menarche, with obesity, PCOS, by NIH criteria, without carbohydrate intolerance and in otherwise good health. Research volunteers will be advised on lifestyle modifications of diet and exercise as per routine, and a GLP-1 agonist will be started according to the product's label as per FDA guidelines in children with obesity. Medication will be titrated to maximal therapeutic dose, as per routine clinical practice. Participants will be treated for a total of 16 weeks. Neuroendocrine rhythms pre- and post-treatment will be compared.
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 ethnic minorities. Normal puberty onset and progression is dependent on normal hypothalamic-pituitary-gonadal (HPG) axis which is affected by whole body metabolism. Gonadotropin-releasing hormone (GnRH) and gonadotropins, LH and FSH, are released in a pulsatile manner for appropriate sex steroids production and gonadal function. Proper pulsatility in the GnRH system is disrupted by a significant change in energy balance such as in obesity. Polycystic Ovary Syndrome (PCOS) is the most common neuroendocrine dysfunction in women of reproductive age.
Glucagon-like peptide-1 (GL-1), a peptide hormone secreted by the intestinal enteroendocrine L-cells following glucose and fat intake, stimulates insulin release by the pancreas in response to glucose, decreases gastric emptying and inhibits glucagon secretion. GLP-1 receptors are present in the hypothalamic nuclei and pituitary gland; and it is thought that GLP-1 may directly stimulate GnRH secretion and partially regulate reproduction. In animal studies, GLP-1 was found to stimulate GnRH secretion, to regulate kisspeptin (Kiss-1) mRNA and GnRH mRAN expression. GLP-1 receptor agonists are established diabetes drugs that are also promising anti-obesity drugs and are FDA-approved to treat adults and adolescents with obesity. Although the impact of GLP-1 receptor agonists in reproductive health has been investigated in preclinical trials, and in men with obesity and functional hypogonadism, no studies to date have investigated the impact of GLP-1 receptor agonists in female neuroendocrine function, particularly in youth.
The goal of this proposal is to gather critical preliminary data to investigate, in a group of obese adolescent females with oligomenorrhea due to PCOS, the impact of GLP-1 agonist administration in addition to lifestyle modifications on -
Aim 1. neuroendocrine rhythms - LH frequency and amplitude (principal); Aim 2. body composition; Aim 3. carbohydrate metabolism and insulin sensitivity. The investigators hypothesize that 16 weeks intervention with a GLP-1 agonist will result in improvement of gonadotropin release patterns.
To accomplish these aims, the investigators will recruit a cohort of up to 20 adolescents ages 12-18 years, at least 2 years post-menarche, with obesity (BMI-for-age equal to or more than the 95th percentile), with PCOS, by NIH criteria: oligomenorrhea and hyperandrogenism (testosterone level or free androgen index > refence range for tanner stage.), in otherwise good health. Research volunteers will be advised on lifestyle modifications of diet and exercise as per routine, and a GLP-1 agonist will be started according to the product's label as per FDA guidelines in children with obesity. Medication will be titrated to maximal therapeutic dose, as per routine clinical practice, and continued for a total of 16 weeks.
Principal Study Outcomes
- Reproductive measures will include change in: LH pulse frequency and amplitude, average levels of LH and FSH, and estradiol, total testosterone
- Body composition will be measured by dual x-ray absorptiometry (DXA) scan
- Carbohydrate metabolism and insulin sensitivity will be measured by HOMA-IR (using fasting insulin and glucose levels).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Females ages 12 to 18 years, at least 2 years post-menarche, with obesity and PCOS.. | – | Drug: GLP-1 Receptor AgonistsFemales ages 12 to 18 years, at least 2 years post-menarche, with obesity (BMI equal to or more than the 95th percentile for age) and with PCOS, by NIH criteria: oligomenorrhea (menstrual cycles <21 or >35 days) [4] and hyperandrogenism (testosterone level or free androgen index (FAI) > refence range for tanner stage) and in good overall health. FAI is calculated as total testosterone*100/sex hormone binding globulin. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescent females with Obesity and PCOS.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1 Receptor AgonistsWeekly subcutaneous Semaglutide. | Drug | Females ages 12 to 18 years, at least 2 years post-menarche, with obesity and PCOS.. |
Primary outcome
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Blood sampling will occur at study enrollment and then 4 months post intervention.
Progesterone will be measured using immunoassay.
Change in LH amplitude.
Time frame: 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.
2 secondary outcomes
Body composition will be measured by dual x-ray absorptiometry (DXA) scan.
Time frame: At enrollment and 4 months post intervention.
Carbohydrate metabolism and insulin sensitivity will be analyzed.
Time frame: Sampling will occur at enrollement and 4 months post intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Background: PubMed 32676541McCartney CR, Campbell RE. Abnormal GnRH Pulsatility in Polycystic Ovary Syndrome: Recent Insights. Curr Opin Endocr Metab Res. 2020 Jun;12:78-84. doi: 10.1016/j.coemr.2020.04.005. Epub 2020 Apr 23.
- Background: PubMed 3899825Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.
- Background: PubMed 35718216Ruffing KM, Koltun KJ, De Souza MJ, Williams NI. Moderate Weight Loss is associated with Reductions in LH Pulse Frequency and Increases in 24-hour Cortisol with no change in Perceived Stress in Young Ovulatory Women. Physiol Behav. 2022 Oct 1;254:113885. doi: 10.1016/j.physbeh.2022.113885. Epub 2022 Jun 16.
- Background: PubMed 18957503McCartney CR, Prendergast KA, Blank SK, Helm KD, Chhabra S, Marshall JC. Maturation of luteinizing hormone (gonadotropin-releasing hormone) secretion across puberty: evidence for altered regulation in obese peripubertal girls. J Clin Endocrinol Metab. 2009 Jan;94(1):56-66. doi: 10.1210/jc.2008-1252. Epub 2008 Oct 28.
- Individual participant dataSharing planned: Yes. All IPD captured during the study trial will be shared deidentified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovarian Syndrome in Adolescent Females and Obesity (Disorder), run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camila Pereira-Eshraghi, MD. MS. (1 + 904-408-7895, camila.pereira-eshraghi@nemours.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07169136, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.