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NCT07169136 · ClinicalTrials.gov registry record

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

A clinical trial of Obesity (Disorder) and Polycystic Ovarian Syndrome in Adolescent Females, sponsored by Nemours Children's Clinic.

Recruiting
Registry status
20
Enrollment target
1
Study location

NCT07169136 is a study of Obesity (Disorder) and Polycystic Ovarian Syndrome in Adolescent Females that is actively recruiting participants, run by Nemours Children's Clinic. The registered enrollment target is 20 participants, below the 110-participant average among 5 other Obesity (Disorder) trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT07169136, a study of Obesity (Disorder) and Polycystic Ovarian Syndrome in Adolescent Females, is actively recruiting participants, sponsored by Nemours Children's Clinic.

RECRUITING
Registry status
20 participants
Enrollment target
1
Study location

Study 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. 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

Conditions Studied

Obesity (Disorder) Polycystic Ovarian Syndrome in Adolescent Females

Interventions

  • DRUG GLP-1 Receptor Agonists

Study Locations (1)

Florida

  • Nemours Children's Clinic - Jacksonville

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2025-09-11
Est. Completion 2026-12

Sponsor

Nemours Children's Clinic

108 total trials

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What the Registry Record Tells You About NCT07169136

The ClinicalTrials.gov registry entry for NCT07169136 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 110-participant average among 5 other Obesity (Disorder) trials with a reported enrollment target (82% lower). The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Obesity (Disorder) appearing as the primary indexed condition, and to 1 intervention - of which GLP-1 Receptor Agonists is the first listed.

NCT07169136 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT07169136 about?

NCT07169136 is a clinical study titled "Effects of Glucagon-like Peptide-1 (GLP-1) Agonist in Neuro-reproductive Function in Obese Adolescent Females With Polycystic Ovary Syndrome (PCOS)". 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-pituita...

What is the current status of trial NCT07169136?

This trial is currently recruiting. The enrollment target is 20 participants. The study started on 2025-09-11. Estimated completion is 2026-12.

What conditions does trial NCT07169136 study?

This clinical trial studies the following conditions: Obesity (Disorder), Polycystic Ovarian Syndrome in Adolescent Females.

What interventions are being tested in trial NCT07169136?

The interventions under investigation include: GLP-1 Receptor Agonists (DRUG).

Who is sponsoring clinical trial NCT07169136?

This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07169136 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.