Semaglutide vs Lifestyle Changes for PCOS
(TEAL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial involves treating girls with obesity and polycystic ovarian syndrome using either a medication that helps control blood sugar and appetite or a specific diet plan. The goal is to reduce liver fat and improve how their bodies use insulin. This group is targeted because they are at higher risk for metabolic diseases like fatty liver and insulin resistance.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications that affect insulin sensitivity, such as metformin, oral glucocorticoids, atypical antipsychotics, immunosuppressants, HIV medications, hormonal contraception, weight loss medications, stimulants, and other GLP-1 agonists. If you are on any of these, you would need to stop them before participating.
Is semaglutide safe for humans?
Semaglutide, used under various brand names like Ozempic, Wegovy, and Rybelsus, has been shown to be generally safe in humans. In studies, it has been associated with very few side effects, and its safety profile is consistent with other similar medications, even in patients with high cardiovascular risk.12345
How does the drug semaglutide differ from other treatments for PCOS?
Semaglutide is unique for PCOS treatment because it is an incretin mimetic drug that helps with weight loss and insulin resistance, which are common issues in PCOS, and it is administered as a once-weekly injection. Unlike standard lifestyle changes, semaglutide has shown significant weight loss and improvement in menstrual cycles in patients unresponsive to lifestyle modifications, with minimal side effects.12678
Who Is on the Research Team?
Melanie Cree-Green, MD, PhD
Principal Investigator
Children's Hospital Colorado
Are You a Good Fit for This Trial?
This trial is for girls with obesity and PCOS who are in the top 10% of weight for their age and gender, don't exercise much, aren't on hormonal birth control, and can avoid pregnancy. It's not for those who are pregnant or breastfeeding, have diabetes or severe illnesses, take certain medications affecting insulin sensitivity, or have specific medical conditions like liver disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either semaglutide or dietary intervention for 12 weeks to decrease metabolic syndrome
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Semaglutide
- Weight loss diet
Semaglutide is already approved in European Union, United States, Canada, Japan for the following indications:
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Obesity
- Type 2 diabetes
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator