NIH-funded research R01 grant

Semaglutide to help restore ovulation in youth 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-11378816 · Data updated 2026-11-12

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

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 year2026
Award (this year)$517,990
NIH project number5R01HD108340-04
Project IDNIH-11378816 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates are adolescents or adults with PCOS, particularly those with obesity or insulin resistance, who may benefit from improved ovulation and metabolic health.

Less likely to help

Patients without PCOS or without ovulatory dysfunction may not benefit from this intervention.

What this research studies

If you or your child has PCOS and struggles with irregular periods and weight-related health issues, this research looks at whether an oral semaglutide helps restore ovulation. The study builds on early findings that this drug can improve glucose and weight patterns, and it aims to see if those benefits translate into more regular menstrual cycles and better hormonal balance. Participants would be monitored over several months to track ovulation, insulin sensitivity, and related health measures. The goal is to offer a new option that could improve fertility and reduce long-term health risks for people with PCOS.

Why it matters

Potential benefit: If successful, the approach could improve ovulation, hormonal balance, and metabolic health for people with PCOS.

How similar studies have gone: Preliminary data in similar GLP-1 RA therapies show potential improvements in menstrual frequency and testosterone levels in PCOS, but results are still early.

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

  • 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

  • Resistant starch to help heart and gut health in PCOS women

    A study tests whether resistant starch can improve heart and metabolic health and the gut bacteria in women with PCOS who have high androgens.

    NIH research University of Pennsylvania · Philadelphia, United States · NIH-11377590

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.