Semaglutide vs Metformin in Polycystic Ovary Syndrome (PCOS)
The Effect of Semaglutide Compared to Metformin in Obese Women With Polycystic Ovary Syndrome (PCOS): a Randomised Controlled Study (Semaglutide-PCOS Trial).
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
1
Recruiting sites
-
Estimated enrollment
60
Study population
Obesity / overweight, PCOS
Eligibility highlights
•BMI ≥30•Female
Primary endpoint
•Body weight, absolute change (kg)
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Inclusion criteria
1. Willingness and ability to provide signed informed consent prior to any trial activity.
2. Women, aged 18-45 years (inclusive), with confirmed diagnosis of PCOS based on Rotterdam criteria [12].
3. Body mass index ≥30 kg/m2
4. Negative pregnancy test during screening visit and agree to use barrier contraception during the study period.
5. Participants from all ethnicities who are English speakers
Exclusion criteria
1. Non-classical 21-hydroxylase deficiency, hyperprolactinaemia, Cushing's disease, and androgen-secreting tumours will be excluded by appropriate tests.
2. Confirmed type 2 diabetes and type 1 diabetes.
3. Pregnancy, breastfeeding or intends to become pregnant.
4. Subjects who are on any of the following medications within 3 months of screening:
5. Have been involved in another medicinal trial (CTIMP) within the past four weeks.
6. Presence or history of neoplasm within 5 years prior to screening. Basal skin carcinoma is allowed.
7. History of pancreatitis
8. Any regular medications that would affect weight management (such as steroids)
9. Any contraindications for treatment with semaglutide.
10. Participants under 18 years
11. Participants who cannot adequately understand verbal and / or written explanations given in English.
12. Confirmed excessive and compulsive drinking of alcohol i.e., alcohol abuse as determined from GP medical notes by the Fast Alcohol Screening Test (FAST) or history of previous alcohol abuse.
13. Moderate to severe renal impairment (creatinine clearance [CrCl] ≤ 60 ml/min or estimated glomerular filtration rate [eGFR] ≤ 60 ml/min/1.73 m2.
14. Severe hepatic insufficiency / and or significant abnormal liver function defines as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and / or alanine aminotransferase (ALT) > 3ULN.
15. History of a major surgical procedure involving the stomach or small intestine which could affect absorption as judged by the investigator.
16. Have severe and enduring mental health problems.
17. Personal or first-degree relative history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid cancer (MTC).
18. Clinical or radiological evidence of thyroid nodules.
19. Any contraindication to the administration of metformin.
Endpoints (6)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsWeight loss (kg)
Time frame:28 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Fat mass
Time frame:28 weeks
Total fat mass
change from baseline, improvement
Glycemic / diabetes
1 endpointGlucose tolerance
Time frame:28 weeks
Postprandial glucose
change from baseline, improvement
Cardiometabolic biomarkers
2 endpointsBlood pressure
Time frame:28 weeks
change from baseline, improvement
Pulse rate
Time frame:28 weeks
Heart rate, change
change from baseline, improvement
Other clinical outcomes
1 endpointFree androgen index (FAI)
Time frame:28 weeks
Androgen, change
percent change from baseline, improvement
Publications (10)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Human reproduction update2013 Sep-Oct (year)PMID23727939doi:10.1093/humupd/dmt015via CT.gov background
- Human reproduction (Oxford, England)2012 Jul (month)PMID22552687doi:10.1093/humrep/des138via CT.gov background
- Clinical endocrinology2008 Dec (month)PMID18410553doi:10.1111/j.1365-2265.2008.03260.xvia CT.gov background
- The Journal of clinical endocrinology and metabolism2008 Sep (month)PMID18583464doi:10.1210/jc.2008-0751via CT.gov background
- The Journal of clinical endocrinology and metabolism2008 Apr (month)PMID18182456doi:10.1210/jc.2007-0425via CT.gov background
- The Journal of clinical endocrinology and metabolism2008 Jan (month)PMID17925334doi:10.1210/jc.2007-1834via CT.gov background
- Human reproduction (Oxford, England)2007 Aug (month)PMID17537782doi:10.1093/humrep/dem108via CT.gov background
- Fertility and sterility2002 Jun (month)PMID12057712doi:10.1016/s0015-0282(02)03111-4via CT.gov background
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.