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UnknownPhase 2, PHASE3

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

University of Hull

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

-

Estimated enrollment

60

Study population

Obesity / overweight, PCOS

Eligibility highlights

BMI ≥30Female

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

NCT IDNCT05646199
Org study IDR2603

Timeline

Milestones

Study first posted2022-12-12actual
Last update posted2024-05-10actual
Study start2025-03-01estimated
Primary completion2025-09-30estimated
Study completion2025-12-30estimated

Assets

Investigational agents

Who this study enrolls

Obesity / overweightPCOS

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexFemale
Healthy volunteersNot accepted

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:

-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

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
Cardiometabolic biomarkers
2
Glycemic / diabetes
1
Other clinical outcomes
1

Weight & body composition

2 endpoints
Primary/protocol endpoint

Weight loss (kg)

Time frame:28 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Fat mass

Time frame:28 weeks

Total fat mass

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Glucose tolerance

Time frame:28 weeks

Postprandial glucose

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Blood pressure

Time frame:28 weeks

change from baseline, improvement

Secondary/protocol endpoint

Pulse rate

Time frame:28 weeks

Heart rate, change

change from baseline, improvement

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Free 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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.