Actively Recruiting
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
Eligibility Criteria
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:
- 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)
- Polycystic ovaries confirmed by ultrasound with 20 or more follicles in at least one ovary
- Biochemical hyperandrogenism (total testosterone over 1.67 nmol/L) or clinical hyperandrogenism (modified Ferriman Gallwey score over 4)
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
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital Fudan University
Shanghai, China, 200032
Actively Recruiting
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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