Semaglutide vs Metformin in Polycystic Ovary Syndrome (PCOS)

Summary

The goal of this clinical trial is to compare the effect of Semaglutide and metformin on weight loss in obese women with Polycystic Ovarian Syndrome (PCOS) over a 28-week treatment period. The main question it aims to answer is: • Which of the 2 drugs, metformin or Semaglutide causes more weight loss when used over a 28 week treatment period in obese women with PCOS? Participants will be divided into 2 groups by chance. In the first group, participants will be asked to take metformin orally. In the second group, participants will take Semaglutide by injection under the skin weekly. The maximum duration of participation for the patients in the trial is 32 weeks. Researchers will compare the weight reduction, quality of life and individuals' wellbeing between the two groups.

Timeline

Start

2025-03-01

Primary completion

2025-09-30

Completion

2025-12-30

Publications

• Background Teede HJ, Joham AE, Paul E, Moran LJ, Loxton D, Jolley D, Lombard C. Longitudinal weight gain in women identified with polycystic ovary syndrome: results of an observational study in young women. Obesity (Silver Spring). 2013 Aug;21(8):1526-32. doi: 10.1002/oby.20213. Epub 2013 Jul 2.
• Background Ovalle F, Azziz R. Insulin resistance, polycystic ovary syndrome, and type 2 diabetes mellitus. Fertil Steril. 2002 Jun;77(6):1095-105. doi: 10.1016/s0015-0282(02)03111-4.
• Background Shaw LJ, Bairey Merz CN, Azziz R, Stanczyk FZ, Sopko G, Braunstein GD, Kelsey SF, Kip KE, Cooper-Dehoff RM, Johnson BD, Vaccarino V, Reis SE, Bittner V, Hodgson TK, Rogers W, Pepine CJ. Postmenopausal women with a history of irregular menses and elevated androgen measurements at high risk for worsening cardiovascular event-free survival: results from the National Institutes of Health--National Heart, Lung, and Blood Institute sponsored Women's Ischemia Syndrome Evaluation. J Clin Endocrinol Metab. 2008 Apr;93(4):1276-84. doi: 10.1210/jc.2007-0425. Epub 2008 Jan 8.
• Background Yildiz BO, Knochenhauer ES, Azziz R. Impact of obesity on the risk for polycystic ovary syndrome. J Clin Endocrinol Metab. 2008 Jan;93(1):162-8. doi: 10.1210/jc.2007-1834. Epub 2007 Oct 9.
• Background Skubleny D, Switzer NJ, Gill RS, Dykstra M, Shi X, Sagle MA, de Gara C, Birch DW, Karmali S. The Impact of Bariatric Surgery on Polycystic Ovary Syndrome: a Systematic Review and Meta-analysis. Obes Surg. 2016 Jan;26(1):169-76. doi: 10.1007/s11695-015-1902-5.
• Background Moran LJ, Ko H, Misso M, Marsh K, Noakes M, Talbot M, Frearson M, Thondan M, Stepto N, Teede HJ. Dietary composition in the treatment of polycystic ovary syndrome: a systematic review to inform evidence-based guidelines. Hum Reprod Update. 2013 Sep-Oct;19(5):432. doi: 10.1093/humupd/dmt015. Epub 2013 May 31. No abstract available.
• Background Thomson RL, Brinkworth GD, Noakes M, Clifton PM, Norman RJ, Buckley JD. The effect of diet and exercise on markers of endothelial function in overweight and obese women with polycystic ovary syndrome. Hum Reprod. 2012 Jul;27(7):2169-76. doi: 10.1093/humrep/des138. Epub 2012 May 2.
• Background Barnard L, Ferriday D, Guenther N, Strauss B, Balen AH, Dye L. Quality of life and psychological well being in polycystic ovary syndrome. Hum Reprod. 2007 Aug;22(8):2279-86. doi: 10.1093/humrep/dem108. Epub 2007 May 30.
• Background Thomson RL, Buckley JD, Noakes M, Clifton PM, Norman RJ, Brinkworth GD. The effect of a hypocaloric diet with and without exercise training on body composition, cardiometabolic risk profile, and reproductive function in overweight and obese women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2008 Sep;93(9):3373-80. doi: 10.1210/jc.2008-0751. Epub 2008 Jun 26.
• Background Sathyapalan T, Cho LW, Kilpatrick ES, Coady AM, Atkin SL. A comparison between rimonabant and metformin in reducing biochemical hyperandrogenaemia and insulin resistance in patients with polycystic ovary syndrome (PCOS): a randomized open-label parallel study. Clin Endocrinol (Oxf). 2008 Dec;69(6):931-5. doi: 10.1111/j.1365-2265.2008.03260.x. Epub 2008 Apr 10.

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Indications