Semaglutide vs Metformin in Polycystic Ovary Syndrome (PCOS)

NCT05646199 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: R2603
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• Weight loss (kg)

  Changes in weight from baseline

  28 weeks

Secondary Outcomes (5)

• Fat mass

  28 weeks

• Free androgen index (FAI)

  28 weeks

• Blood pressure

  28 weeks

• Pulse rate

  28 weeks

• Glucose tolerance

  28 weeks

Study Arms (2)

Metformin

ACTIVE COMPARATOR

Participants in this group will be given metformin

Drug: Metformin

Semaglutide

ACTIVE COMPARATOR

Participants in this group with receive Semaglutide

Drug: Semaglutide Injectable Product

Interventions

Metformin DRUG

Participants will receive metformin

Metformin

Semaglutide Injectable Product DRUG

Participants in this group will receive injectable Semaglutide

Semaglutide

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Willingness and ability to provide signed informed consent prior to any trial activity.
• Women, aged 18-45 years (inclusive), with confirmed diagnosis of PCOS based on Rotterdam criteria \[12\].
• Body mass index ≥30 kg/m2
• Negative pregnancy test during screening visit and agree to use barrier contraception during the study period.
• Participants from all ethnicities who are English speakers

You may not qualify if:

• Non-classical 21-hydroxylase deficiency, hyperprolactinaemia, Cushing's disease, and androgen-secreting tumours will be excluded by appropriate tests.
• Confirmed type 2 diabetes and type 1 diabetes.
• Pregnancy, breastfeeding or intends to become pregnant.
• Subjects who are on any of the following medications within 3 months of screening:
• Metformin or other insulin-sensitizing medications (e.g. pioglitazone)
• Hormonal contraceptives (e.g. birth control pills, hormone-releasing implants. Locally acting hormone - containing IUD such as Mirena coil is permitted).
• Anti-androgens (e.g., spironolactone, flutamide, finasteride, etc.)
• Clomiphene citrate or oestrogen modulators such as letrozole
• GnRH modulators such as leuprolide
• Minoxidil
• Have been involved in another medicinal trial (CTIMP) within the past four weeks.
• Presence or history of neoplasm within 5 years prior to screening. Basal skin carcinoma is allowed.
• History of pancreatitis
• Any regular medications that would affect weight management (such as steroids)
• Any contraindications for treatment with semaglutide.

Sponsors & Collaborators

• University of Hull: lead

Study Sites (1)

Hull University Teaching Hospitals NHS Trust

Hull, HU32RW, United Kingdom

Location

Related Publications (10)

• 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.

  PMID: 23818329 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.

  PMID: 12057712 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.

  PMID: 18182456 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.

  PMID: 17925334 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.

  PMID: 26431698 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.

  PMID: 23727939 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.

  PMID: 22552687 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.

  PMID: 17537782 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.

  PMID: 18583464 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.

  PMID: 18410553 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Thozhukat Sathyapalan, MD, FRCP

  University of Hull

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chair in Academic Diabetes, Endocrinology and Metabolism

CONTACT

+441482675387; thozhukat.sathyapalan@hyms.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 12, 2022
• Study Start: March 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)