Efficacy of Mazdutide for Treating PCOS
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: endocrine, other_emerging
- Who it enrolls
- age 18 Years to 40 Years; female; excludes diabetes; BMI ≥28 required; conditions: Polycystic Ovary Syndrome
- Interventions
- Mazdutide
- Conditions
- Polycystic Ovary Syndrome
- Phase and size
- Phase 1, Phase 2 · 50 participants
- Dates
- Start 2024-10-21
Primary completion 2025-12-31 - Sponsor
- Shanghai Zhongshan Hospital (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Free Androgen Index (FAI)24 weeks
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.