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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 belowSelect...
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
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.
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.
Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists in the Treatment of Obese Women with Polycystic Ovary Syndrome.
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Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,049 Previous Clinical Trials
2,731,065 Total Patients Enrolled
106 Trials studying Obesity
102,590 Patients Enrolled for Obesity
University of Colorado, DenverLead Sponsor
1,802 Previous Clinical Trials
2,822,032 Total Patients Enrolled
106 Trials studying Obesity
214,426 Patients Enrolled for Obesity
Melanie Cree-Green, MD,PhDPrincipal InvestigatorUniversity of Colorado Anschutz/Children's Hospital Colorado
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