Status
Recruiting
Phase
Phase 1 / Phase 2
Enrollment
50
Locations
1
Results
Not posted
Publications
0
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.
Interventions
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.
Timeline
First posted
Jul 25, 2024
Study start
Oct 21, 2024
Primary completion
Dec 31, 2025
Study completion
Jun 30, 2026
Results posted
Not reported
Registry updated
Oct 24, 2024
Outcomes
Free Androgen Index (FAI)
Time frame · 24 weeks
FAI=total testosterone (nmol/L)/ sex hormone binding globulin (nmol/L) X 100
Times of regular menses
Time frame · 24 weeks
Record of vaginal bleeding within 24 weeks after using Mazdutide
Number of immature follicles
Time frame · 24 weeks
Total number of follicles measuring 2-9 mm in diameter on ultrasound
Bilateral ovary volume
Time frame · 24 weeks
Total ovary volume is calculated based on length, width and height of bilateral ovaries measured by ultrasound
Serum anti-Mullerian hormone (AMH)
Time frame · 24 weeks
Measurement of serum AMH
HOMA insulin resistance index (HOMA-IR)
Time frame · 24 weeks
HOMA-IR=fasting plasma glucose (mmol/L)×fasting insulin (μU/mlINS)/22.5
HbA1c
Time frame · 24 weeks
Measurement of HbA1c
body mass index (BMI)
Time frame · 24 weeks
BMI = weight / height² (weight in kilograms and height in meters)
Eligibility
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 locations
China. Showing up to 24 locations stored in the fast local snapshot.
Zhongshan Hospital Fudan University
Shanghai, China
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
West China Hospital · Metabolic Dysfunction-Associated Steatohepatitis · Hepatic Steatosis
Phase 2 / Phase 3
Not yet recruiting
60
2026-07
Eli Lilly · Obesity · Overweight
Phase 2
Recruiting
1,481
2026-07
Tianjin Medical University · Type 2 Diabetes Mellitus (T2DM) · Nonalcoholic Fatty Liver Disease (NAFLD) With History of Diabetes Melitus
Not applicable
Not yet recruiting
72
2026-07
Eli Lilly · Alcohol Use Disorder
Phase 2
Completed
308
2026-07
China National Center for Cardiovascular Diseases · Obesity & Overweight · Coronary Heart Disease
Phase 4
Not yet recruiting
116
2026-06
Shandong Provincial Hospital · Prediabetes · Impaired Fasting Glucose
Phase 4
Not yet recruiting
150
2026-06
Innovent Biologics (Suzhou) Co. Ltd. · Type 2 Diabetes · Obesity
Phase 3
Completed
349
2026-06
China-Japan Friendship Hospital · Obesity
Not applicable
Recruiting
200
2026-06
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.