Efficacy of Mazdutide for Treating PCOS

Fudan University

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Polycystic Ovary Syndrome

Treatments

Drug: Mazdutide

Study type

Interventional

Funder types

Other

Identifiers

NCT06519656

B2024-190R2

Details and patient eligibility

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.

Enrollment

50 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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