RecruitingPhase 1Phase 2NCT06519656

Efficacy of Mazdutide for Treating PCOS

A Clinical Efficacy Study of Mazdutide in the Treatment of Polycystic Ovary Syndrome


Sponsor

Shanghai Zhongshan Hospital

Enrollment

50 participants

Start Date

Oct 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether mazdutide, a drug originally developed for weight management and diabetes, can help treat polycystic ovary syndrome (PCOS) — a hormonal condition that affects menstrual cycles and fertility. **You may be eligible if...** - You have a BMI of 28 or higher - You are not planning to become pregnant in the next 8 months - You meet the criteria for PCOS: irregular periods, polycystic ovaries on ultrasound, or elevated male hormones (at least 2 of 3 criteria) **You may NOT be eligible if...** - You have a history of pancreatitis - You or a family member has had medullary thyroid cancer or a condition called multiple endocrine neoplasia (MEN2) - Your triglycerides are severely elevated - You have type 1 or type 2 diabetes - You have another hormonal disorder causing PCOS-like symptoms (e.g., Cushing's syndrome, prolactinoma) - You are pregnant or breastfeeding - You have serious heart, liver, or kidney disease - You have any type of cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMazdutide

In the initial 4 weeks, the subjects are given Mazdutide 2mg once weekly. If well tolerated, the dosage is increased to 4mg once weekly for another 4 weeks. If still well tolerated, the dosage is further increased to 6mg once weekly and maintained for the ensuing 16 weeks.


Locations(1)

Zhongshan Hospital Fudan University

Shanghai, China

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NCT06519656


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