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The Role of the GIP/GLP-1 dual receptor agonist tirzepatide in patients with polycystic ovary syndrome and overweight/obesity: A randomized, controlled clinical trial

The Clinical Study of GIP/GLP-1 Dual Receptor Agonists in Overweight and Obese Patients with Polycystic Ovary Syndrome

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105880
Enrollment
Unknown
Registered
2025-07-14
Start date
2025-07-30
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Control group:Oral administration of metformin
group A:Tirzepatide injection therapy
group B:Treatment with metformin combined with tirzepatide

Sponsors

The Second Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Women of childbearing age aged 18 - 40 years; 2. BMI ranging from 24.0 to 38.0 kg/m^2; 3. Without other serious chronic diseases; 4. Normal liver function, kidney function, HIV/HCV, and electrocardiogram; 5. Meeting the diagnostic criteria for polycystic ovary syndrome (PCOS diagnostic criteria are based on the Rotterdam criteria in 2003), and excluding other diseases such as congenital adrenal hyperplasia, Cushing's syndrome, and androgen-secreting tumors; 6. Voluntarily participating in the trial after fully understanding the trial content and signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with diabetes (type 1 or type 2) before enrollment; 2. Patients with previous chronic diseases of the heart, liver, and kidneys; 3. Patients with a family history and personal history of thyroid cancer; 4. Patients with a history of drug allergy, allergic disorders or allergic constitution; smokers and heavy drinkers; 5. Patients with Cushing's syndrome, congenital adrenal hyperplasia, benign and malignant tumors of various systems, abnormal liver and kidney functions, organic heart diseases, rheumatoid arthritis, systemic lupus erythematosus, polycystic kidney, mental diseases, chronic diseases such as HIV/tuberculosis/HCV, etc.; 6. Patients with a history of using glucocorticoids, estrogens, progestogens, and insulin drugs within 3 months before enrollment; Patients who cannot cooperate with the follow-up for personal reasons; 7. Pregnant patients; 8. Also includes: 1) Patients who have participated in other clinical trials within one month before the test or are currently participating in other clinical trials; 2) Patients who the researchers consider not suitable for the clinical trial for other reasons.

Design outcomes

Primary

MeasureTime frame
BMI;Waist-to-hip ratio;blood pressure;

Secondary

MeasureTime frame
Pregnancy status after follow - up medication;

Countries

China

Contacts

Public ContactDongfang Liu/Cong Wang

The Second Affiliated Hospital of Chongqing Medical University

303791@hospital.cqmu.edu.cn+86 182 0235 4957

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026