Efficacy of Mazdutide for Treating PCOS

Phase 1

Recruiting

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Mazdutide

• Registration Number: NCT06519656
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-14
• Study First Submitted QC: 2024-07-19
• Study First Posted: 2024-07-25
• Status Verified: 2024-10
• Study Start: 2024-10-21
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mazdutide Treatment Arm	Mazdutide	Subcutaneous injection of Mazdutide once weekly for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Free Androgen Index (FAI)	24 weeks	FAI=total testosterone (nmol/L)/ sex hormone binding globulin (nmol/L) X 100

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, China