Semaglutide for Polycystic Ovary Syndrome

Overseen By Bethany Brauer

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Methodist Health System

Must not be taking: Hormonal contraceptives, Insulin

Disqualifiers: Hysterectomy, Endometrial ablation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how semaglutide, a medication, could potentially help women with Polycystic Ovary Syndrome (PCOS). Researchers seek to determine if semaglutide can manage symptoms associated with PCOS. Suitable candidates for this trial have a PCOS diagnosis, a body mass index (BMI) over 30, and are not currently using hormone-based contraceptives. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this potentially beneficial treatment.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, especially if you are using hormone-containing contraceptives, insulin, or specific fertility treatments like letrozole or clomiphene citrate. The trial does not specify a washout period, but these medications are excluded from participation.

Is there any evidence suggesting that semaglutide is likely to be safe for humans?

Research has shown that semaglutide is a safe treatment for women with Polycystic Ovary Syndrome (PCOS). Commonly used for Type 2 diabetes, this medication can also be safely used by women with PCOS. It belongs to a group of treatments known as GLP-1 receptor agonists, which help with weight loss and are generally well-tolerated.

Some studies have found that semaglutide can cause side effects like nausea or digestive issues, but these are usually mild. In one study with PCOS patients, semaglutide was used at a low dose and helped with weight loss without major safety concerns. However, since this trial is still in its early stages, more information is needed to fully understand its safety for this specific use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PCOS?

Semaglutide is unique because it offers a new approach to managing Polycystic Ovary Syndrome (PCOS) by targeting the GLP-1 receptor, which is different from the hormonal or insulin-sensitizing treatments typically used. Most current treatments for PCOS focus on hormonal regulation or improving insulin sensitivity, like birth control pills and metformin. Semaglutide, originally developed for diabetes, has shown promise in regulating appetite and metabolism, which could address weight management issues often associated with PCOS. Researchers are excited because semaglutide could offer a dual benefit of metabolic regulation and weight loss, potentially improving overall health outcomes for women with PCOS.

What evidence suggests that semaglutide might be an effective treatment for PCOS?

Research shows that semaglutide, the investigational treatment in this trial, can help women with Polycystic Ovary Syndrome (PCOS). Studies have found that semaglutide aids nearly 80% of women with PCOS who are obese and haven't achieved weight loss through lifestyle changes. It also improves body mass index (BMI) and cholesterol levels, which are crucial for managing PCOS. Additionally, semaglutide reduces waist size, lowers blood fat levels, and decreases testosterone levels, all beneficial for women with PCOS. These findings suggest that semaglutide may help manage PCOS symptoms. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for women aged 18-45 with a BMI over 30 who have been diagnosed with Polycystic Ovarian Syndrome (PCOS). Participants must have normal levels of certain hormones. Women using hormone-based contraceptives, fertility drugs, insulin, or those who've had a hysterectomy or endometrial ablation cannot join.

Inclusion Criteria

I have been diagnosed with PCOS.

Body mass index(BMI) > 30

Normal thyroid stimulating hormone, prolactin, follicle-stimulating hormone (FSH), estradiol, and normal progesterone

Exclusion Criteria

I am not using any hormone-based birth control methods.

I take insulin for my diabetes.

I have had a hysterectomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide therapy to assess its effects on ovulation, menstrual regularity, androgen levels, weight, BMI, and HbA1c

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide

Trial Overview

The study is looking at the effects of Semaglutide on women with PCOS to see if it can be an effective treatment. It's not clear how many groups there are or if there will be comparisons to other treatments.

How Is the Trial Designed?

Group I: Protocol group Experimental Treatment 1 Intervention

PCOS women in the age 18 to 45 years

Semaglutide is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in United States as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Canada as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Japan as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in United States as Wegovy for:

• Obesity

Approved in United States as Rybelsus for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

Methodist Health System

Lead Sponsor

Trials

156

Recruited

4,826,000+

Published Research Related to This Trial

Semaglutide (Ozempic®) is an effective once-weekly treatment for type 2 diabetes, showing superior glucose-lowering effects and greater weight loss compared to other GLP-1 receptor agonists in Phase III clinical trials.

It is approved for use in Belgium for patients with type 2 diabetes who have not achieved adequate control with other antidiabetic therapies, particularly in those with a body mass index of 30 kg/m² or higher.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. Scheen, AJ.[2019]

In a study of 27 obese patients with PCOS who did not respond to lifestyle modifications, treatment with semaglutide led to an average weight loss of 7.6 kg after three months, with 80% of participants achieving at least a 5% reduction in body weight.

Semaglutide treatment not only resulted in significant weight loss but also improved insulin sensitivity and normalized menstrual cycles in 80% of responsive patients, all with minimal side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide Treatment of Excessive Body Weight in Obese PCOS Patients Unresponsive to Lifestyle Programs. Carmina, E., Longo, RA.[2023]

Oral semaglutide significantly reduced HbA1c levels in Japanese patients by 1.0% to 1.7% depending on the dosage, showing greater or similar efficacy compared to other diabetes medications.

The treatment also led to notable body weight reductions of up to 4.7%, with gastrointestinal side effects being the most common but generally mild to moderate, indicating that it is well tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral semaglutide in Japanese patients with type 2 diabetes: A post hoc subgroup analysis of the PIONEER 1, 3, 4 and 8 trials. Araki, E., Terauchi, Y., Watada, H., et al.[2022]

Oral semaglutide (Rybelsus®) has been shown to provide better glycaemic control and promote weight loss in patients with type 2 diabetes (T2DM) compared to standard oral glucose-lowering medications, based on data from the PIONEER clinical trial program involving 9543 patients.

The safety profile of oral semaglutide is similar to other GLP-1 receptor agonists, and it demonstrated cardiovascular safety comparable to placebo in high-risk patients, making it a viable option for T2DM management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. Paquot, N.[2022]

Oral semaglutide is the first FDA-approved oral GLP-1 receptor agonist for type 2 diabetes, showing effectiveness in reducing blood sugar levels and body weight in patients with uncontrolled diabetes, while maintaining a safety profile similar to injectable GLP-1RAs.

It is particularly beneficial for patients with inadequate glycemic control on other medications, those needing weight loss, and those at risk of hypoglycemia, but it is contraindicated in individuals with a history of certain thyroid cancers and pancreatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating oral semaglutide into clinical practice in primary care: for whom, when, and how? Brunton, SA., Mosenzon, O., Wright, EE.[2020]

In a 52-week study involving 731 patients with type 2 diabetes, oral semaglutide significantly reduced HbA1c levels and body weight compared to placebo, demonstrating its efficacy when added to insulin with or without metformin.

The most common side effect of oral semaglutide was nausea, which was mostly mild to moderate, indicating a safety profile similar to other glucagon-like peptide 1 receptor agonists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial. Zinman, B., Aroda, VR., Buse, JB., et al.[2022]

Semaglutide, a GLP-1 receptor agonist for type 2 diabetes, has a good safety profile but is associated with a high prevalence of gastrointestinal disorders, reported in over 3500 cases (53.2%).

Compared to other diabetes medications like sitagliptin and empagliflozin, semaglutide has a significantly higher number of reported gastrointestinal adverse events, indicating the need for careful monitoring in certain patient subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal disorders potentially associated with Semaglutide: an analysis from the Eudravigilance Database. Cabral Lopes, A., Roque, F., Lourenço, O., et al.[2023]

In a study of 20 patients with type 2 diabetes in Slovenia, oral semaglutide significantly reduced HbA1c levels and fasting plasma glucose, indicating its efficacy in improving glycaemic control.

Patients reported high satisfaction with the treatment, and while some experienced mild gastrointestinal side effects, the overall safety profile was considered good, suggesting that oral semaglutide is a promising option for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and patient satisfaction with oral semaglutide: first single-centre clinical experience. Janić, M., Jovanović, M., Janež, A., et al.[2023]

Semaglutide, marketed as Rybelsus, is the first oral glucagon-like peptide receptor agonist approved by the FDA in 2019 for treating type 2 diabetes, highlighting its innovative delivery method.

This medication, taken once daily, aids in glucose control and weight management, potentially leading to improved health outcomes for individuals with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. Blakely, KK., Weaver, K.[2021]

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Ozempic and PCOS: What Are the Benefits and Risks?

You can safely take Ozempic (semaglutide) to treat Type 2 diabetes if you have polycystic ovary syndrome (PCOS). PCOS is a complex hormone ...