NCT06896981

Semaglutide in Women With Polycystic Ovary Syndrome and Obesity

Recruiting now Phase 2, PHASE3 Last updated 2 April 2025

What this trial tests

Phase 2, PHASE3 trial testing Metformin with Semaglutide in Polycystic Ovary Syndrome (PCOS) Women in 30 participants. Currently enrolling.

Timeline

1 February 2025

Primary endpoint
31 October 2025

31 December 2025

Quick facts

Lead sponsor	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Phase	Phase 2, PHASE3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 February 2025
Primary completion	31 October 2025
Estimated completion	31 December 2025
Sites	1 location across Bangladesh

Drugs / interventions tested

• Metformin with Semaglutide — full drug profile →

Conditions studied

• Polycystic Ovary Syndrome (PCOS) Women — all drugs for Polycystic Ovary Syndrome (PCOS) Women →
• Obesity — all drugs for Obesity →

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Who can join

Adults 10 to 45, female only, with Polycystic Ovary Syndrome (PCOS) Women or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Polycystic Ovary Syndrome (PCOS) is a common endocrine disorder that is frequently associated with metabolic features, including obesity. Improvement of metabolic manifestations helps in the control of symptoms, including subfertility. Metformin has been commonly used to decrease insulin resistance and weight in PCOS patients suffering from obesity. Glucagon-like peptide (GLP-1) agonist semaglutide is also effective in managing different metabolic features, including obesity and insulin resistance. There is limited data about using a combination of semaglutide and metformin in women with PCOS suffering from obesity. This study aims to compare the metabolic changes after giving a combination of low-dose semaglutide and metformin vs. metformin alone over 12 weeks among women with PCOS and obesity. This open label randomized trial will be conducted in the Department of Endocrinology, Bangabandhu Sheikh Mujib Medical University (BSMMU). After obtaining informed written consent, a total of 30 patients with PCOS and obesity will be enrolled conveniently (sampling) in the study as per inclusion and exclusion criteria from the outdoor, indoor, and PCOS clinic, Endocrinology, BSMMU. Study participants will be divided into two groups randomly by a computerized random number generator (allocation). One study arm will be treated with low-dose subcutaneous semaglutide (0.25 mg/week for 4 weeks followed by 0.5mg per week for 12 weeks) in combination with metformin (500 mg bid). Another study arm will receive monotherapy with metformin (500 mg bid) for treatment. Both arms will receive standard unified lifestyle advices. Patients will be followed every four weeks for clinical data for up to twelve weeks. Laboratory tests will be done at baseline and the final follow-up in an 8 - 12 hours of fasting state. Two mL of blood will be used to measure glucose using the glucose oxidase method on the same day of sample collection. The remaining three mL of blood will be centrifuged, the serum will be separated and analyzed for insulin, TT, SHBG, ALT and lipid profiles on the same day. All the clinical and biochemical information will be documented in a pretested, semi-structured case record form. Recorded data will be entered, edited, and analyzed by SPSS software version 25.0. Data will be expressed as frequencies \& percentages (%) for qualitative values and mean \& standard deviation (±SD) or median \& inter-quartile range (IQR) for quantitative values depending on their distribution. Kaplan Meier Curve will be used to show the comparison between primary outcomes. For quantitative variables, a comparison between two groups will be done using Mann-Whitney U test, and within a group, a paired t-test or Wilcoxon test will be used. For qualitative variables, a comparison between two groups will be tested using Pearson's chi-square test and within the group by the McNemar test. Regression Analysis will be done to correlate between treatment and outcome. Any p-value below 0.05 will be considered statistically significant. Confidentiality will be strictly maintained. Informed written consent will be taken from patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.