Semaglutide in Women With Polycystic Ovary Syndrome and Obesity

Launched by BANGABANDHU SHEIKH MUJIB MEDICAL UNIVERSITY, DHAKA, BANGLADESH · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how effective a combination of two medications, semaglutide and metformin, is in improving health for women who have Polycystic Ovary Syndrome (PCOS) and are also struggling with obesity. PCOS is a condition that can lead to various health problems, including difficulty getting pregnant and weight gain. The trial aims to see if adding semaglutide to metformin, a standard treatment for these patients, can lead to better results over a 12-week period.

To participate in this study, women aged between 18 and 45 who have been diagnosed with PCOS and obesity are eligible, as long as they do not have certain other health issues, like diabetes or significant heart or kidney problems. Participants will be randomly assigned to one of two groups: one will receive both semaglutide and metformin, while the other will take metformin alone. Throughout the study, participants will receive lifestyle advice and will have regular check-ups and blood tests to monitor their health. This trial is important because it could help find better treatment options for women dealing with PCOS and obesity.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Reproductive-aged women with PCOS diagnosed according to International evidence based guidelines 2023 and obesity
• Exclusion Criteria:
• • 1. Having DM, other significant systemic diseases- chronic kidney disease (eGFR \<60mL/minute/ 1.73 m2 BSA), chronic liver disease (ALT \>3 × ULN), and heart failure
• • 2. Patients having PCOS mimicking endocrine disorders (untreated thyroid dysfunctions, hyperprolactinemia, congenital adrenal hyperplasia, Cushing's syndrome, acromegaly, hypothalamic disorder etc.)
• • 3. Those taking any other weight loss medications (eg., orlistat, liraglutide) within the last 3 months
• • 4. Those who have undergone bariatric surgery
• • 5. Any conditions causing weight loss (thyrotoxicosis, Addison's disease, chronic infection, connective tissue disorder, cancer, etc)
• • 6. Secondary causes of obesity (major mood disorders, steroids, valproate, oral contraceptives, etc)
• • 7. Contraindications for semaglutide: personal or family history of medullary carcinoma of the thyroid, history of acute pancreatitis, gallbladder disease
• • 8. Planning for pregnancy or current pregnancy/ lactation