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Recruiting NCT06519656

Efficacy of Mazdutide for Treating PCOS

Phase I / Phase II Interventional Polycystic Ovary Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mazdutide.
Who it may be relevant to
Registry conditions: Polycystic Ovary Syndrome. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Drug Mazdutide
    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.

Primary outcome measures

  • Free Androgen Index (FAI) [Time frame: 24 weeks]
Secondary outcome measures (7)
  • Times of regular menses [Time frame: 24 weeks]
  • Number of immature follicles [Time frame: 24 weeks]
  • Bilateral ovary volume [Time frame: 24 weeks]
  • Serum anti-Mullerian hormone (AMH) [Time frame: 24 weeks]
  • HOMA insulin resistance index (HOMA-IR) [Time frame: 24 weeks]
  • HbA1c [Time frame: 24 weeks]
  • body mass index (BMI) [Time frame: 24 weeks]

Eligibility criteria

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 :
  • Irregular cycles and ovulatory dysfunction: < 21 or > 35 days or < 8 cycles per year; > 90 days for any one cycle
  • Polycystic ovaries: ≥20 follicles in at least one of two ovaries (diameter<10mm), confirmed by ultrasound
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhongshan Hospital Fudan University — Shanghai

Identifiers

NCT: NCT06519656 · B2024-190R2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗