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Effects of Glucagon-like Peptide-1 (GLP-1) Agonist in Neuro-reproductive Function in Obese Adolescent Females With Polycystic Ovary Syndrome (PCOS)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 18 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: X-rays

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Body composition will be measured by dual x-ray absorptiometry (DXA) scan 3."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how a GLP-1 medicine, along with diet and exercise changes, affects hormones, body fat, and blood sugar use. It is for girls ages 12–18 with obesity and polycystic ovary syndrome (PCOS), a condition that affects hormones and periods. Treatment lasts 16 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have PCOS with periods less than 21 or more than 35 days apart and higher-than-normal levels of male-type hormones for your stage of puberty.
  • Be in good overall health.
  • Have obesity, with body size at or above the 95th percentile.
  • Be female and 12–18 years old, with your first period at least 2 years ago.
  • Still have PCOS symptoms and obesity after at least 4 months of lifestyle changes.

Who can't join

  • Have abnormal thyroid blood tests at screening.
  • Have diabetes.
  • Have non-classic congenital adrenal hyperplasia, an inherited condition that affects hormone production.
  • Have high levels of prolactin, a hormone that helps the body make breast milk.
  • Have a personal or family history of medullary thyroid cancer or MEN2, a condition linked to tumors, and a history of pancreatitis (swelling of the pancreas).
  • Have received GLP-1 medicines, birth control pills, or progesterone for at least 6 weeks before screening.
  • Are pregnant now or have ever been pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

FL