NCT06519656 Efficacy of Mazdutide for Treating PCOS
| NCT ID | NCT06519656 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Polycystic Ovary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-10-21 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2024-10-21 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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 : 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
Contact & Investigator
XI DONG, MD
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT06519656 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Polycystic Ovary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06519656 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06519656 currently recruiting?
Yes, NCT06519656 is actively recruiting participants. Contact the research team at mu.liangshan@zs-hospital.sh.cn for enrollment information.
Where is the NCT06519656 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06519656 clinical trial?
NCT06519656 is sponsored by Shanghai Zhongshan Hospital. The principal investigator is XI DONG, MD at Fudan University. The trial plans to enroll 50 participants.