NIH-funded research R01 grant

Semaglutide to help restore monthly ovulation in teens and adults with PCOS

Official title: Role of semaglutide in restoring ovulation in youth and adults with polycystic ovary syndrome

Funded at University of Colorado Denver · NIH-11188966 · Data updated 2026-11-12

This project gives semaglutide to teens and adults with polycystic ovary syndrome (PCOS) to help with weight, insulin control, and return to regular ovulation.

More Polycystic Ovary Syndrome research and trials

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionUniversity of Colorado Denver
NIH-funded
Lab location1 site (Aurora, UNITED STATES)
Project startAugust 15, 2023
Project endJuly 31, 2028
Funding year2025
Award (this year)$526,747
NIH project number5R01HD108340-03
Project IDNIH-11188966 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates are adolescents and adults with a diagnosis of PCOS, especially those with obesity or insulin resistance and irregular or absent menstrual cycles, who can attend clinic visits in Aurora, Colorado.

Less likely to help

People without PCOS, those who are pregnant or planning pregnancy, those with contraindications to GLP-1 receptor agonists, or those unwilling/unable to attend regular clinic visits may not benefit or be eligible.

What this research studies

If you have PCOS and struggle with irregular or absent periods, researchers will give semaglutide and follow you over time to track menstrual cycles, hormones, weight, and blood sugar responses. The team will measure insulin sensitivity, post-meal glucose, testosterone, and whether ovulation resumes after treatment. The trial enrolls both adolescents and adults and expands on an initial short pilot that showed metabolic improvements with oral semaglutide. Visits will include blood tests, menstrual tracking, and in-person clinic appointments.

Why it matters

Potential benefit: If successful, semaglutide could restore regular ovulation and improve menstrual health, metabolic control, and weight for people with PCOS.

How similar studies have gone: Smaller trials of older GLP-1 drugs like liraglutide and exenatide showed improved menstrual frequency and lower testosterone, and a short semaglutide pilot in adolescents improved metabolic measures but did not yet confirm ovulation restoration.

Where this research is happening

  • University of Colorado Denver
    Aurora, United States
    Active

Researchers

  • Principal investigator: Cree, Melanie G — University of Colorado Denver
  • Study coordinator: Cree, Melanie G

Related research

Other NIH-funded projects on the same topics.

  • SMAD5 and PCOS/PMOS: a new genetic clue to infertility

    A research project at Baylor College of Medicine is studying a genetic variant in SMAD5 that may cause a form of PCOS/PMOS and could lead to new ways to diagnose or treat infertility.

    NIH research Baylor College of Medicine · Houston, United States · NIH-11595517

  • TLR4 blocker for improving fertility in PCOS

    A promising, already-approved drug (disulfiram) will be tested to see if it can reduce inflammation and improve ovulation in women with PCOS.

    NIH research University of California-Irvine · Irvine, United States · NIH-11456298

  • Genetic clues to PCOS: how genes shape a common women's health condition

    A doctor-scientist team at Boston Children’s Hospital is studying how genetic factors contribute to polycystic ovary syndrome (PCOS) across women, men, and children to understand the root causes.

    NIH research Boston Children's Hospital · Boston, United States · NIH-11402645

  • Semaglutide to help restore ovulation in youth and adults with PCOS

    A study tests an oral GLP-1 receptor agonist (semaglutide) to improve ovulation and hormonal balance in people with polycystic ovary syndrome (PCOS).

    NIH research University of Colorado Denver · Aurora, UNITED STATES · NIH-11378816

  • Understanding how PCOS develops during adolescence

    This grant looks at how polycystic ovary syndrome begins in teenagers and what early signs help doctors diagnose it accurately.

    NIH research Cornell University · Ithaca, United States · NIH-11378637

  • AI-powered ultrasound tool to help diagnose PCOS

    A new AI-based tool uses ultrasound images to help doctors reliably identify polycystic ovary syndrome (PCOS) in reproductive-age women.

    NIH research Cornell University · Ithaca, United States · NIH-11378391

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.