NCT06519656招募中1 期
A Clinical Efficacy Study of Mazdutide in the Treatment of Polycystic Ovary Syndrome
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Free Androgen Index (FAI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mazdutide Treatment Arm
Experimental
Subcutaneous injection of Mazdutide once weekly for 24 weeks.
干预措施: Mazdutide (Drug)
结局指标
主要结局
Free Androgen Index (FAI)
时间窗: 24 weeks
FAI=total testosterone (nmol/L)/ sex hormone binding globulin (nmol/L) X 100
次要结局
- Number of immature follicles(24 weeks)
- HOMA insulin resistance index (HOMA-IR)(24 weeks)
- body mass index (BMI)(24 weeks)
- Times of regular menses(24 weeks)
- Bilateral ovary volume(24 weeks)
- Serum anti-Mullerian hormone (AMH)(24 weeks)
- HbA1c(24 weeks)
研究者
研究点 (1)
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