What side effects are associated with this type of intervention?

Common treatments for Polycystic Ovary Syndrome (PCOS) include GLP-1 receptor agonists like liraglutide and semaglutide, which can cause gastrointestinal side effects such as nausea and vomiting. There are also concerns about the potential risk of pancreatitis and gallbladder disease with these medications. Metformin, another common treatment, primarily causes gastrointestinal discomfort and has a rare risk of lactic acidosis.

What prior FDA approvals exist?

The FDA has not specifically approved GLP-1 receptor agonists like liraglutide and semaglutide for the treatment of Polycystic Ovary Syndrome (PCOS). However, these drugs are being studied for their potential benefits in PCOS due to their effects on insulin secretion, glucagon inhibition, gastric emptying, and satiety. These mechanisms can help address metabolic issues and weight management, which are common concerns in PCOS. Currently, these medications are primarily approved for type 2 diabetes and obesity management.

What other types of research exist?

Promising alternatives to GLP-1 receptor agonists for PCOS patients include metformin, which improves insulin sensitivity and promotes weight loss, and inositol, which has shown potential in improving metabolic and reproductive outcomes. Additionally, orlistat, a weight loss medication, may be considered for its ability to reduce body weight. These alternatives can be used alone or in combination with lifestyle interventions.

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Glucagon-like peptide-1 receptor agonist

Semaglutide for Polycystic Ovary Syndrome (RESTORE Trial)

Phase 3

Recruiting

Led By Melanie Cree-Green, MD,PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with PCOS per the most stringent NIH criteria with adaptation for adolescents (oligomenorrhea >24 months post-menarche or primary amenorrhea after age 15 years and clinical/ biochemical hypertestosteronemia

If 18-35 years, initial BMI ≥30 kg/m2 OR initial BMI ≥27 kg/m2 with at least one weight-related comorbid condition, e.g., hypertension or dyslipidemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial involves girls and women aged 12-35 with obesity and PCOS taking a medication that helps manage blood sugar and promote weight loss. The goal is to see if this treatment can improve their weight and reproductive health.

Who is the study for?

This trial is for girls and women aged 12-35 with obesity and polycystic ovary syndrome (PCOS), who may or may not be taking metformin. Participants should exercise less than 2 hours a week, have irregular periods, and meet specific PCOS criteria. They must not use hormonal contraception but can use non-hormonal methods.

What is being tested?

The study tests the effects of Semaglutide (Wegovy) on metabolic changes, weight loss, and reproductive health in participants with PCOS over 10 months. Some will also continue their metformin treatment if they've been stable on it for at least three months.

What are the potential side effects?

Semaglutide might cause digestive issues like nausea or diarrhea, potential allergic reactions, increased heart rate, pancreatitis risk increase, kidney problems or gallbladder issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with PCOS following strict NIH criteria, including irregular periods or high testosterone.

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I am 18-35 years old with a BMI of 30 or more, or a BMI of 27 or more with a condition like high blood pressure.

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I am female.

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I am between 12 and 35 years old.

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I am under 18 and my BMI is in the top 5% for my age.

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I have been taking at least 1500 mg of metformin daily for over 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in ovulation frequency before and after semaglutide in females with PCOS

Secondary study objectives

Change in Whole Body Insulin Sensitivity

Change in ovarian morphology

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Untreated PCOSExperimental Treatment1 Intervention

Participants with PCOS who are not on metformin or hormonal therapy, will receive 10-months of semaglutide intervention. Participants will get either semaglutide as either: Wegovy: 0.25mg for 4 weeks, 0.5mg for 4 weeks, 1mg 4-weeks, and 1.7mg for the remainder of the study. or Ozempic: 0.25mg for 4 weeks, 0.5mg for 4 weeks, 1mg 4-weeks, and Wegovy for 1.7mg for the remainder of the study.

Group II: PCOS on MetforminExperimental Treatment1 Intervention

Participants with PCOS who are currently on metformin and still not having regular menses, will receive 10-months of semaglutide intervention. Participants in this arm will continue to take their metformin throughout the trial. Participants will get either semaglutide as either: Wegovy: 0.25mg for 4 weeks, 0.5mg for 4 weeks, 1mg 4-weeks, and 1.7mg for the remainder of the study. or Ozempic: 0.25mg for 4 weeks, 0.5mg for 4 weeks, 1mg 4-weeks, and Wegovy for 1.7mg for the remainder of the study.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

GLP-1 receptor agonists, such as liraglutide and semaglutide, are increasingly used in the treatment of PCOS due to their ability to enhance insulin secretion, inhibit glucagon release, slow gastric emptying, and promote satiety. These mechanisms help improve insulin sensitivity and promote weight loss, which are crucial for managing PCOS symptoms like hyperandrogenism and anovulation. Metformin, another common treatment, reduces insulin concentrations and promotes ovulation, while hormonal contraceptives help regulate menstrual cycles and reduce androgen levels. Together, these treatments address both the metabolic and reproductive abnormalities associated with PCOS, improving overall patient outcomes.

Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists in the Treatment of Obese Women with Polycystic Ovary Syndrome.