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Efficacy of Mazdutide for Treating PCOS

Efficacy of Mazdutide for Treating PCOS

Recruiting
18-40 years
Female
Phase 1/2

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Overview

The goal of this clinical trial is to learn the efficacy of Mazdutide in treating obese female adults diagnosed with polycystic ovary syndrome (PCOS). The main question it aims to answer is: Does Mazdutide lower the free androgen index (FAI) in obese female adults with PCOS? Participants will take Mazdutide once every week for 24 weeks and visit the clinic once every 4 weeks for checkups and tests.

Eligibility

Inclusion Criteria:

  • BMI≥28kg/M2
  • No plan for pregnancy in the coming 8 months after enrollment
  • Patients should meet at least two of the three criteria according to the 2023 international evidence-based guideline for PCOS :
    1. Irregular cycles and ovulatory dysfunction: < 21 or > 35 days or < 8 cycles per year; > 90 days for any one cycle
    2. Polycystic ovaries: ≥20 follicles in at least one of two ovaries (diameter<10mm), confirmed by ultrasound
    3. Biochemical hyperandrogenism: total testosterone>1.67 nmol/L or clinical hyperandrogenism: modified Ferriman Gallwey score (mFG)>4

Exclusion Criteria:

  • Previous history of acute or chronic pancreatitis or pancreatic injury
  • Previous history or family history of medullary thyroid cancer, multiple endocrine neoplasia type 2a or 2b
  • Severe hypertriglyceridemia (TG>5mmol/L)
  • Type 1 or type 2 diabetes mellitus
  • Other endocrine diseases that can cause secondary PCOS, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc
  • Pregnancy or breast-feeding
  • Patients with other serious diseases affecting heart, liver, kidney, or other major organs
  • Patients with any type of cancer

Study details
    Polycystic Ovary Syndrome

NCT06519656

Shanghai Zhongshan Hospital

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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