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Tests treatment safety and results for Polycystic Ovary Syndrome
Official title Efficacy of Mazdutide for Treating PCOS
ClinicalTrials.gov ID: NCT06519656
What this study is testing
What is Mazdutide?
Mazdutide is an investigational medicine, given as an once-weekly, being studied as a potential treatment for polycystic ovary syndrome.
Also referred to as GLP-1R and GCGR dual agonist.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only
You may be able to join if
- 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: \ 35 days or \ 90 days for any one cycle
- Polycystic ovaries: ≥20 follicles in at least one of two ovaries (diameter\<10mm), confirmed by ultrasound
You likely can't join if
- 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...
- Pregnancy or breast-feeding
See the full eligibility 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 :
- Irregular cycles and ovulatory dysfunction: \ 35 days or \ 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.