Using Mazdutide to treat PCOS in obese women
A Clinical Efficacy Study of Mazdutide in the Treatment of Polycystic Ovary Syndrome
This study is testing if a new medication called Mazdutide can help obese women with polycystic ovary syndrome (PCOS) by lowering their hormone levels over 24 weeks.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06519656 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy of Mazdutide in treating obese female adults diagnosed with polycystic ovary syndrome (PCOS). Participants will receive Mazdutide injections once a week for 24 weeks and will attend clinic visits every four weeks for monitoring and assessments. The primary objective is to determine whether Mazdutide can effectively lower the free androgen index (FAI) in this patient population. The study will include various eligibility criteria to ensure appropriate candidate selection.
Who should consider this trial
Good fit: Ideal candidates for this study are obese female adults with a BMI of 28 or higher who have been diagnosed with PCOS.
Not a fit: Patients with a history of certain endocrine disorders or severe hypertriglyceridemia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for managing PCOS symptoms in obese women.
How similar studies have performed: While there may be other studies exploring treatments for PCOS, the specific use of Mazdutide in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai
- Zhongshan Hospital Fudan University — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Xi Dong, Md — Fudan University
- Study coordinator: LIANGSHAN MU, MD, PhD
- Email: mu.liangshan@zs-hospital.sh.cn
- Phone: 02164041990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.