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NCT05646199
Semaglutide vs Metformin in Polycystic Ovary Syndrome (PCOS)
Phase 2, PHASE3 trial testing Metformin in Polycystic Ovary Syndrome in 60 participants. Not yet recruiting.
30 September 2025
Quick facts
| Lead sponsor | University of Hull |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 March 2025 |
| Primary completion | 30 September 2025 |
| Estimated completion | 30 December 2025 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Metformin (metformin) — full drug profile →
- Semaglutide Injectable Product — full drug profile →
Conditions studied
- Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →
Sponsor
University of Hull
Who can join
Adults 18 to 45, female only, with Polycystic Ovary Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Semaglutide as a GLP-1 Agonist: A Breakthrough in Obesity Treatment.
Salvador R, Moutinho CG, Sousa C, Vinha AF, et al · · 2025 · cited 9× · PMID 40143174 · DOI 10.3390/ph18030399
Verify or expand the search:
- PubMed search for NCT05646199
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07585396 — Inositol in Letrozol Resistant PCOS Women · Phase 2, PHASE3 · not yet recruiting
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Other recruiting trials for Polycystic Ovary Syndrome
Currently open trials in the same condition.
- NCT07591246 — Efficay of Physical Activity Program in PCOS Females With Fatty Pancrease and Thyroid Hypofunction · NA · recruiting
- NCT07446985 — Is There a Benefit From Addition of Physical Exercise to Diet Restriction/Limitation in PCOS Women With Asthma? · NA · recruiting
- NCT07385716 — Evaluation of the Effect of Time-Restricted Feeding and Mediterranean Diet Model in Women With Polycystic Ovary Syndrome · NA · recruiting
- NCT07366944 — PCOS and Problem of Eye Dryness: Is There a Benefit From Lifetyle Changes · NA · recruiting
- NCT07289399 — Is There a Benefit From Addition of Treadmill Walking to Diet Restriction in Psoriasis Women With PCOS? · NA · recruiting
Other University of Hull trials
Trials by the same sponsor.
- NCT06276686 — Exercise for Improving Long-course Chemoradiotherapy Efficacy in People With Locally Advanced Rectal Cancer · EARLY_PHASE1 · recruiting
- NCT07299682 — Facilitating Effective Eating With DoddleBags: A Single-Arm Acceptability Study Of DoddleBags to Assess Impact on Self F · NA · recruiting
- NCT07376694 — Improving Uptake of Bowel Cancer Screening Among South Asian Adults in Bradford · NA · active not recruiting
- NCT06595316 — Exercise for Ameliorating Chemotherapy Cardiotoxicity · NA · not yet recruiting
- NCT06292975 — Exercise for Improving Radiotherapy Efficacy in Rectal Cancer · NA · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05646199 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Hull
- Last refreshed: 10 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05646199.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing