Clinical trial

Efficacy of Mazdutide for Treating PCOS

Recruiting now · Phase 1, Phase 2 · 1 countries · Registry ID NCT06519656

Recruiting nowPhase 1, Phase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 40 Years

SexFemale

Healthy volunteersNot accepted

ConditionPolycystic Ovary Syndrome

Full registry 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

Treatments and study arms

Mazdutide

Drug

In the initial 4 weeks, the subjects are given Mazdutide 2mg once weekly. If well tolerated, the dosage is increased to 4mg once weekly for another 4 weeks. If still well tolerated, the dosage is further increased to 6mg once weekly and maintained for the ensuing 16 weeks.

Primary outcomes

Free Androgen Index (FAI)24 weeks

FAI=total testosterone (nmol/L)/ sex hormone binding globulin (nmol/L) X 100

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Zhongshan Hospital Fudan University🇨🇳 Shanghai, China

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LIANGSHAN MU, MD, PhDContact

Email · Call 02164041990

JINGJING JIANG, MD, PhDContact

Email · Call 02164041990

Xi Dong, MDPrincipal Investigator