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Efficacy of Mazdutide for Treating PCOS

RECRUITINGPhase 1/2Sponsored by Shanghai Zhongshan Hospital
Actively Recruiting
PhasePhase 1/2
SponsorShanghai Zhongshan Hospital
Started2024-10-21
Est. completion2025-12-31
Eligibility
Age18 Years – 40 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06519656

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

Age: 18 Years – 40 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions2

CancerPolycystic Ovary Syndrome

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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