Using Semaglutide and Metformin to Treat Obesity in Women with PCOS
Comparison Between the Effects of Low-Dose Semaglutide With Metformin vs. Metformin Alone Over Metabolic Profile in Obese Polycystic Ovary Syndrome: A Phase II Randomized Controlled Trial
This study is testing if a combination of low-dose semaglutide and metformin can help women with PCOS and obesity manage their weight and improve their symptoms better than metformin alone.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 10 Years to 45 Years |
| Sex | Female |
| Sponsor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Academic / other |
| Locations | 1 site (Dhaka, Dhaka Division) |
| Trial ID | NCT06896981 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a combination of low-dose semaglutide and metformin compared to metformin alone in women with Polycystic Ovary Syndrome (PCOS) and obesity. The study aims to assess metabolic changes over a 12-week period, focusing on improving symptoms associated with PCOS, such as insulin resistance and weight management. Participants will be reproductive-aged women diagnosed with PCOS and obesity, and the trial will be conducted at the Department of Endocrinology at Bangabandhu Sheikh Mujib Medical University in Dhaka, Bangladesh.
Who should consider this trial
Good fit: Ideal candidates for this study are reproductive-aged women diagnosed with PCOS and obesity.
Not a fit: Patients with diabetes, significant systemic diseases, or those taking other weight loss medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for managing obesity and metabolic symptoms in women with PCOS.
How similar studies have performed: While there is limited data on the combination of semaglutide and metformin specifically for PCOS, similar approaches have shown promise in managing obesity and metabolic disorders.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dhaka, Dhaka Division
- Department of Endocrinology, Bangabandhu Sheikh Mujib Medical University — Dhaka, Dhaka Division, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Muhammad Abul Hasanat, MD — Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Study coordinator: Muhammad Abul Hasanat, MD
- Email: hasnat_endo@bsmmu.edu.bd
- Phone: +880 1711-670735
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.