Efficacy of Mazdutide for Treating PCOS

NCT ID: NCT06519656

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-21
• Study Completion Date: 2026-06-30

Brief Summary

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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mazdutide Treatment Arm

Subcutaneous injection of Mazdutide once weekly for 24 weeks.

Group Type: EXPERIMENTAL

Mazdutide

Intervention Type: 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.

Interventions

Mazdutide

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.

Intervention Type: DRUG

Other Intervention Names

GLP-1R and GCGR dual agonist

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

XI DONG, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Zhongshan Hospital Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

LIANGSHAN MU, MD, PhD

Role: CONTACT

mu.liangshan@zs-hospital.sh.cn

02164041990 ext. 695904

JINGJING JIANG, MD, PhD

Role: CONTACT

jiang.jingjing@zs-hospital.sh.cn

02164041990 ext. 692023

Facility Contacts

LIANGSHAN MU, MD, PhD

Role: primary

mu.liangshan@zs-hospital.sh.cn

02164041990 ext. 695904

JINGJING JIANG, MD, PhD

Role: backup

jiang.jingjing@zs-hospital.sh.cn

02164041990 ext. 692023

Other Identifiers

B2024-190R2

Identifier Type: -

Identifier Source: org_study_id