Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 40Years
FEMALE
NCT06519656

Efficacy of Mazdutide for Treating PCOS

Led by Shanghai Zhongshan Hospital · Updated on 2024-10-24

50

Participants Needed

1

Research Sites

88 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Efficacy of Mazdutide for Treating PCOS

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 to 40 years
  • Body mass index (BMI) of 28 kg/m2 or higher
  • No plans for pregnancy in the 8 months after enrollment
  • Must meet at least two of the following PCOS criteria according to 2023 guidelines:
    1. Irregular menstrual cycles with ovulatory dysfunction (less than 21 or more than 35 days, fewer than 8 cycles per year, or any cycle longer than 90 days)
    2. Polycystic ovaries confirmed by ultrasound with 20 or more follicles in at least one ovary
    3. Biochemical hyperandrogenism (total testosterone over 1.67 nmol/L) or clinical hyperandrogenism (modified Ferriman Gallwey score over 4)
Not Eligible

You will not qualify if you...

  • History of acute or chronic pancreatitis or pancreatic injury
  • Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2a or 2b
  • Severe hypertriglyceridemia (triglycerides over 5 mmol/L)
  • Type 1 or type 2 diabetes mellitus
  • Other endocrine diseases causing secondary PCOS such as 21 hydroxylase deficiency, prolactinoma, hypothyroidism, or Cushing's syndrome
  • Pregnancy or breastfeeding
  • Serious diseases affecting heart, liver, kidney, or other major organs
  • Any type of cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhongshan Hospital Fudan University

Shanghai, China, 200032

Actively Recruiting

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Research Team

L

LIANGSHAN MU, MD, PhD

CONTACT

J

JINGJING JIANG, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Efficacy of Mazdutide for Treating PCOS | DecenTrialz