Status:
RECRUITING
Efficacy of Mazdutide for Treating PCOS
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
PHASE2
Brief 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 Mazd...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06519656
Start Date
October 21 2024
End Date
June 30 2026
Last Update
October 24 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Zhongshan Hospital Fudan University
Shanghai, China, 200032