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NCT Number: NCT06519656

Efficacy of Mazdutide for Treating PCOS

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 :
  • Irregular cycles and ovulatory dysfunction: < 21 or > 35 days or < 8 cycles per year; > 90 days for any one cycle
  • Polycystic ovaries: ≥20 follicles in at least one of two ovaries (diameter<10mm), confirmed by ultrasound
  • 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

Treatment and study plan

Mazdutide

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.

Other names: GLP-1R and GCGR dual agonist

Primary outcomes

  1. Free Androgen Index (FAI)

    Time frame: 24 weeks

    FAI=total testosterone (nmol/L)/ sex hormone binding globulin (nmol/L) X 100

Secondary outcomes

  1. Times of regular menses

    Time frame: 24 weeks

    Record of vaginal bleeding within 24 weeks after using Mazdutide

  2. Number of immature follicles

    Time frame: 24 weeks

    Total number of follicles measuring 2-9 mm in diameter on ultrasound

  3. Bilateral ovary volume

    Time frame: 24 weeks

    Total ovary volume is calculated based on length, width and height of bilateral ovaries measured by ultrasound

  4. Serum anti-Mullerian hormone (AMH)

    Time frame: 24 weeks

    Measurement of serum AMH

  5. HOMA insulin resistance index (HOMA-IR)

    Time frame: 24 weeks

    HOMA-IR=fasting plasma glucose (mmol/L)×fasting insulin (μU/mlINS)/22.5

  6. HbA1c

    Time frame: 24 weeks

    Measurement of HbA1c

  7. body mass index (BMI)

    Time frame: 24 weeks

    BMI = weight / height² (weight in kilograms and height in meters)

Study contacts

Contact information is provided by the study sponsor or research team.

JINGJING JIANG, MD, PhD

CONTACT

[email protected]

02164041990 ext. 692023

LIANGSHAN MU, MD, PhD

CONTACT

[email protected]

02164041990 ext. 695904

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 25, 2024
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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