An observational study in Polycystic Ovarian Syndrome in Adolescent Females and Obesity (Disorder), sponsored by Nemours Children's Clinic. Recruiting at 1 site in United States. Open to female participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Nemours Children's Clinic · Observational
Among 14 studies in Obesity by Nemours Children's Clinic — 2 open to participants now, 2 under way, none of them phase 3. Obesity · Nemours Children's Clinic.
Among the 14 studies in Obesity by Nemours Children's Clinic, this one is one of 2 that started in 2025, is one of 2 observational ones, and was the 13th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 20 is below the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →2 of the 14 studies in Obesity by Nemours Children's Clinic are open now, in 1 country. Each count lists the studies.
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 12 Years to 18 Years · female · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2025.
Median enrollment 39 across the 11 interventional studies, 20 across the 3 observational. Of the 12 that completed or were terminated, 4 (33%) have results posted.
Nemours Children's Clinic is the lead sponsor of 130 studies on the registry; 26 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
1 of the studies in Obesity by Nemours Children's Clinic that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07169136Nemours Children's ClinicEffects of Glucagon-like Peptide-1 (GLP-1) Agonist in Neuro-reproductive Function in Obese Adolescent Females With Polycystic Ovary Syndrome (PCOS) | 2026-12 |
Among the 14 studies in Obesity by Nemours Children's Clinic, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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
Adolescent females with Obesity and PCOS.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: GLP-1 Receptor Agonists
Weekly subcutaneous Semaglutide.
This study also gives Semaglutide. No intervention listed here names it: that was found by reading the record.
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Blood sampling will occur at study enrollment and then 4 months post intervention.
Body composition will be measured by dual x-ray absorptiometry (DXA) scan.
Body composition will be measured by DEXA (Hologic Discovery A)
Time frame: 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).
Time frame: Sampling will occur at enrollement and 4 months post intervention.
Plan to share: Yes — All IPD captured during the study trial will be shared deidentified.
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