Semaglutide for Polycystic Ovary Syndrome

CN
BB
Overseen ByBethany Brauer
Age: 18 - 65
Sex: Female
Trial Phase: Phase 1
Sponsor: Methodist Health System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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.12345

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.34567

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.
See 4 more

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?
1Treatment groups
Experimental Treatment
Group I: Protocol groupExperimental Treatment1 Intervention

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

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Approved in European Union as Ozempic for:
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Approved in United States as Ozempic for:
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Approved in Canada as Ozempic for:
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Approved in Japan as Ozempic for:
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Approved in United States as Wegovy for:
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Approved in United States as Rybelsus for:

Find a Clinic Near You

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.
[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.
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.
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]

Citations

Semaglutide Treatment of Excessive Body Weight in ...Treatment with semaglutide, at low doses, significantly reduces body weight in almost 80% of obese PCOS patients who were unresponsive to a previous lifestyle ...
Semaglutide vs Metformin in Polycystic Ovary Syndrome ...In patients with type 2 diabetes, there was ≥5% weight loss in 63% of patients treated with Semaglutide. On the other hand, liraglutide has shown around 5-7 kg ...
Effects of combined metformin and semaglutide therapy on ...The results indicate that the combination therapy significantly reduced body weight and FBG levels compared to MET monotherapy, though it did ...
The efficacy and safety of GLP-1 agonists in PCOS women ...In summary, GLP1-RAs can reduce waist circumference, BMI, serum triglycerides and total testosterone in women with polycystic ovarian syndrome (PCOS). This ...
Meta-analysis of the effects of semaglutide on body mass ...Semaglutide significantly improves BMI and lipid profiles in PCOS, particularly at higher doses, and in obese patients. Further long-term studies are needed to ...
Semaglutide: Double-edged Sword with Risks and BenefitsSemaglutide can also be used to treat chronic kidney disease and polycystic ovary syndrome. Semaglutide therapy has adverse anesthetic risks due to delayed ...
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 ...
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