What side effects are associated with this type of intervention?

Common treatments for Polycystic Ovarian Syndrome (PCOS) include Glucagon-like peptide-1 (GLP-1) receptor agonists like liraglutide and semaglutide, which can cause gastrointestinal issues such as nausea, vomiting, and diarrhea, and carry potential risks of acute pancreatitis and gallbladder disease. There is also a concern about the long-term risk of thyroid C cell tumors. Metformin, another common treatment, can cause gastrointestinal discomfort, lactic acidosis (rarely), and vitamin B12 deficiency. Combined oral contraceptives (COCs) can lead to weight gain, mood changes, and an increased risk of thromboembolic events.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists, such as liraglutide and semaglutide, primarily for the treatment of type 2 diabetes and obesity. These drugs enhance insulin secretion, inhibit glucagon release, and slow gastric emptying. While not specifically approved for Polycystic Ovarian Syndrome (PCOS), their effects on weight loss and insulin sensitivity make them relevant for managing metabolic aspects of PCOS. Clinical trials are ongoing to evaluate their efficacy in treating PCOS.

What other types of research exist?

Promising alternatives to GLP-1 receptor agonist therapy for PCOS patients include metformin, which improves insulin sensitivity and reduces hepatic glucose production, and inositol, which has been shown to improve ovarian function and metabolic parameters. Orlistat, which aids in weight loss by inhibiting fat absorption, is another option. These alternatives have shown efficacy in managing PCOS symptoms and may be considered in treatment plans.

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GLP-1 Receptor Agonist

Semaglutide vs Lifestyle Changes for PCOS (TEAL Trial)

Phase 2 & 3

Waitlist Available

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

BMI equal or greater than the 90th percentile for age and gender

PCOS per the most stringent NIH criteria adapted for adolescents (irregular menses >12 months post-menarche and clinical or biochemical hypertestosteronemia)

Must not have

History of severe GI disease (e.g. gastroparesis)

Severe illness requiring hospitalization within 60 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The study compares two approaches to treat metabolic issues caused by obesity and PCOS: one group will receive Semaglutide (a medication), while another will follow a weight loss diet. The goal is to reduce liver fat and improve how the body uses insulin over a period of 12 weeks.

What are the potential side effects?

Semaglutide may cause side effects such as digestive problems (nausea, vomiting), risk of low blood sugar levels if combined with other diabetes medicines, possible thyroid tumors including cancer (rare), pancreatitis, gallbladder problems like gallstones.

Eligibility Criteria

Inclusion Criteria

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

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My BMI is in the top 10% for my age and gender.

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I have PCOS, diagnosed with irregular periods and high testosterone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe stomach or intestine condition.

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I have not been hospitalized for a severe illness in the last 60 days.

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I have had gallstones in the past.

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I have had pancreatitis before.

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I have liver disease, but it's not NAFLD, or my liver enzymes are high.

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I am currently experiencing symptoms or receiving treatment for an eating disorder.

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My last A1C level was above 6.4%, indicating diabetes.

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I haven't used metformin, certain steroids, psychiatric drugs, immunosuppressants, HIV drugs, hormonal birth control (past 6 months), weight loss drugs, stimulants, or GLP-1 agonists recently.

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I have a thyroid condition that hasn't been treated.

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I or someone in my family has medullary thyroid cancer or MEN 2.

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I have kidney disease or my kidney function test is low.

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My BMI is below the 90th percentile for my age and sex, and my weight is either over 325 lbs or under 84 lbs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 weeks 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 Hepatic Fat Fraction

Change in Weight

Secondary study objectives

Insulin

Change in Rate of De Novo Lipogenesis

Change in Whole Body Insulin Sensitivity

Other study objectives

Change in Free Androgen Index

Evaluation of Mitochondrial function via change in ratios of direct to indirect hepatic carbon flux in newly synthesized triglycerides

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: GLP-1 InterventionExperimental Treatment1 Intervention

Participants will take a daily oral tablet of semaglutide for 4 months.

Group II: Diet InterventionActive Control1 Intervention

Weight loss with dietary intervention

0 / 14Eligibility 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

Common treatments for Polycystic Ovarian Syndrome (PCOS) often target insulin resistance and hyperinsulinemia, which are central to the condition's pathophysiology. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, thereby improving insulin sensitivity and reducing hyperinsulinemia. Metformin, another frequently used treatment, enhances insulin sensitivity and decreases hepatic glucose production. These mechanisms are vital for PCOS patients as they help manage the metabolic disturbances that contribute to the reproductive and hyperandrogenic symptoms of the syndrome.

The Role of Glp-1 Receptor Agonists in Insulin Resistance with Concomitant Obesity Treatment in Polycystic Ovary Syndrome.Lifestyle intervention and anti-obesity therapies in the polycystic ovary syndrome: impact on metabolism and fertility.