Testing a weight loss medication to restore regular periods in young women with PCOS

Plain-English translation of NCT05819853 on ClinicalTrials.gov ↗ · Source last updated August 2026 · Translation generated September 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This trial is testing whether semaglutide, a medication originally developed for weight loss and diabetes, can help restore regular menstrual cycles in young women and teens with polycystic ovary syndrome (PCOS) who are living with obesity. Researchers know that excess weight worsens PCOS symptoms, including irregular or missing periods. This study will see if weight loss from the medication can help the body's reproductive system work better again.

PCOS is one of the most common hormonal conditions in women and often causes irregular or missing periods, especially in young people. While metformin (an older medication) helps some women, many still struggle with irregular periods even when taking it. Researchers want to know if this medication might offer better results by addressing the weight-related factors that drive PCOS symptoms.

Do you qualify?

You likely qualify if…

you are female and between ages 12 and 35 years old
you have been diagnosed with PCOS with irregular or missing periods
you are living with obesity (BMI in the 95th percentile or higher if under 18, or BMI of 30 or higher if 18–35)
you are not currently taking hormonal birth control and can use non-hormonal contraception (like a copper IUD) or remain abstinent during the study
you exercise less than 2 hours per week of moderate activity

You likely don't qualify if…

you have a personal or family history of medullary thyroid cancer or MEN2 syndrome
you are currently pregnant, breastfeeding, or planning to become pregnant during the study
you have been diagnosed with diabetes or have severe kidney disease
you are taking weight loss medications, other GLP-1 medications, or certain hormonal medications in the months before screening
you have a personal history of pancreatitis or severe digestive disorders like gastroparesis

What participation looks like

The study lasts about 14 months total. You'll start with a 4-month observation period where you either take no medication or continue metformin if you're already on it. Then you'll receive 10 months of semaglutide injections, starting at a low dose and gradually increasing over the first month to reach the full dose. Throughout the study, researchers will track your weight, menstrual cycles, hormone levels, and metabolic health through blood tests and office visits to see if the medication helps restore your periods and understand how weight loss affects your reproductive health.

AI-generated summary from trial data · Sep 4, 2026 · Not medical advice

Trial locations(1 site)

United States

University of Colorado Anschutz/Children's Hospital Colorado Aurora, Aurora, Colorado