Efficacy of Mazdutide for Treating PCOS

Last updated: October 22, 2024
Sponsor: Shanghai Zhongshan Hospital
Overall Status: Active - Recruiting

Phase

1/2

Condition

Reproductive Health

Polycystic Ovarian Syndrome

Treatment

Mazdutide

Clinical Study ID

NCT06519656
B2024-190R2
  • Ages 18-40
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 2023international evidence-based guideline for PCOS :

  1. Irregular cycles and ovulatory dysfunction: < 21 or > 35 days or < 8 cycles peryear; > 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 clinicalhyperandrogenism: modified Ferriman Gallwey score (mFG)>4

Exclusion

Exclusion Criteria:

  • Previous history of acute or chronic pancreatitis or pancreatic injury

  • Previous history or family history of medullary thyroid cancer, multiple endocrineneoplasia 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 limitedto: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc

  • Pregnancy or breast-feeding

  • Patients with other serious diseases affecting heart, liver, kidney, or other majororgans

  • Patients with any type of cancer

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Mazdutide
Phase: 1/2
Study Start date:
October 21, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Zhongshan Hospital Fudan University

    Shanghai, 200032
    China

    Active - Recruiting

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