Efficacy of Mazdutide for Treating PCOS

A Clinical Efficacy Study of Mazdutide in the Treatment of Polycystic Ovary Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Drug: Mazdutide

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: LIANGSHAN MU, MD, PhD; Phone Number: 695904 02164041990; Email: mu.liangshan@zs-hospital.sh.cn
• Study Contact Backup: Name: JINGJING JIANG, MD, PhD; Phone Number: 692023 02164041990; Email: jiang.jingjing@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Zhongshan Hospital Fudan University
    • Contact: LIANGSHAN MU, MD, PhD; Phone Number: 695904 02164041990; Email: mu.liangshan@zs-hospital.sh.cn
    • Contact: JINGJING JIANG, MD, PhD; Phone Number: 692023 02164041990; Email: jiang.jingjing@zs-hospital.sh.cn
    • Principal Investigator: Xi Dong, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mazdutide Treatment Arm; Subcutaneous injection of Mazdutide once weekly for 24 weeks.	Drug: 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.; Other Names: GLP-1R and GCGR dual agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Free Androgen Index (FAI)	FAI=total testosterone (nmol/L)/ sex hormone binding globulin (nmol/L) X 100	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Times of regular menses	Record of vaginal bleeding within 24 weeks after using Mazdutide	24 weeks
Number of immature follicles	Total number of follicles measuring 2-9 mm in diameter on ultrasound	24 weeks
Bilateral ovary volume	Total ovary volume is calculated based on length, width and height of bilateral ovaries measured by ultrasound	24 weeks
Serum anti-Mullerian hormone (AMH)	Measurement of serum AMH	24 weeks
HOMA insulin resistance index (HOMA-IR)	HOMA-IR=fasting plasma glucose (mmol/L)×fasting insulin (μU/mlINS)/22.5	24 weeks
HbA1c	Measurement of HbA1c	24 weeks
body mass index (BMI)	BMI = weight / height² (weight in kilograms and height in meters)	24 weeks

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: XI DONG, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 14, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Pathologic Processes; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Syndrome; Polycystic Ovary Syndrome
• Other Study ID Numbers: B2024-190R2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No