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Trial Title:
Efficacy of Mazdutide for Treating PCOS
NCT ID:
NCT06519656
Condition:
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Mazdutide
Description:
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.
Arm group label:
Mazdutide Treatment Arm
Other name:
GLP-1R and GCGR dual agonist
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongshan Hospital Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
LIANGSHAN MU, MD, PhD
Phone:
02164041990
Phone ext:
695904
Email:
mu.liangshan@zs-hospital.sh.cn
Contact backup:
Last name:
JINGJING JIANG, MD, PhD
Phone:
02164041990
Phone ext:
692023
Email:
jiang.jingjing@zs-hospital.sh.cn
Investigator:
Last name:
Xi Dong, MD
Email:
Principal Investigator
Start date:
October 21, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Source:
Shanghai Zhongshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06519656
