NCT06519656CompletedPhase 1/2
Efficacy of Mazdutide for Treating PCOS
A Clinical Efficacy Study of Mazdutide in the Treatment of Polycystic Ovary Syndrome
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 14 Jul 2024
- Start date
- Oct 2024
- Primary completion date
- Sept 2026
- Lead sponsor
- Shanghai Zhongshan Hospital
- NCT number
- NCT06519656
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 43
- From Oct 2024 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- Patients with other serious diseases affecting heart, liver, kidney, or other major organs
- Patients with any type of cancer
Other
- Severe hypertriglyceridemia (TG\>5mmol/L)
- Pregnancy or breast-feeding
Who the study is looking for
- 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
Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.