Efficacy of Mazdutide for Treating PCOS

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT06519656
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Polycystic Ovary Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Jul 25, 2024
Start date
Oct 21, 2024
Status verified
Oct 2024
Primary completion
Sep 1, 2026
Completion
Sep 18, 2026

Study Design

Enrollment
43 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mazdutide Treatment Arm
    Subcutaneous injection of Mazdutide once weekly for 24 weeks.

Primary Outcome Measure

Free Androgen Index (FAI) [ Time Frame: 24 weeks ]

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