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NCT05702905
Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome
Phase 4 trial testing Metformin Hydrochloride 500 MG in PCOS (Polycystic Ovary Syndrome) in 75 participants. Status unknown.
31 December 2024
Quick facts
| Lead sponsor | Peking University First Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 75 |
| Start date | 9 May 2023 |
| Primary completion | 31 December 2024 |
| Estimated completion | 30 June 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Metformin Hydrochloride 500 MG
- Semaglutide, 1.34 mg/mL — full drug profile →
- Semaglutide, 1.34 mg/mL and Metformin Hydrochloride 500 MG — full drug profile →
- calorie-restricted diet
- physical exercise
Conditions studied
- PCOS (Polycystic Ovary Syndrome) — all drugs for PCOS (Polycystic Ovary Syndrome) →
- Semaglutide — all drugs for Semaglutide →
Sponsor
Peking University First Hospital
Who can join
Adults 22 to 40, female only, with PCOS (Polycystic Ovary Syndrome) or Semaglutide. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To investigate the efficacy of semaglutide in obese infertile women of childbearing age with polycystic ovary syndrome (PCOS), we design this prospective, randomized, open and controlled study. 75 obese infertile PCOS patients will be recruited and randomized into three groups: metformin, semaglutide and metformin+semaglutide, on the basis of calorie-restricted diet and physical exercise. All subjects will be treated for 12 weeks, and then stop taking the drug for at least 8 weeks to initiate ovulation induction or ovulation induction combined with artificial insemination. All subjects will be followed up for 24 weeks for pregnancy outcome. The primary endpoint of the study is the percentage of weight loss at 12 weeks of treatment. The secondary endpoints include HOMA-IR and androgen levels at 12 weeks of treatment, ovulation rate at 24 weeks of follow-up, clinical pregnancy rate and cumulative pregnancy rate, and depression, anxiety, diet and quality of life scores at 12 weeks of treatment.
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 NCT05702905
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Metformin Hydrochloride 500 MG
Trials testing the same drug.
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- NCT06229795 — Effect of Green Tea on Obese Pediatrics With Prediabetes · Phase 3 · completed
- NCT06215976 — The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer · Phase 4 · recruiting
- NCT05981742 — Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activiti · Phase 2 · completed
- NCT05753371 — Bioequivalence Study of Metformin Hydrochloride 500 mg Film-Coated Tablets in Indonesia Healthy Subject · NA · completed
Other recruiting trials for PCOS (Polycystic Ovary Syndrome)
Currently open trials in the same condition.
- NCT07197255 — Transcriptomic Profiling of Cumulus Cells From CAPA-IVM · recruiting
- NCT07159880 — Letrozole Extended vs Traditional Therapy for Ovulation Induction in Women With PCOS (PROLEx-PCOS) · NA · recruiting
- NCT07426146 — Feasibility Effects of a Low-GI, High-fibre Diet in PCOS: a Prospective Cohort Study in Remote Yunnan · recruiting
- NCT07448272 — Letrozole 5 mg for 10 Days Versus Letrozole 10 mg for 5 Days for Ovarian Stimulation in PCOS · NA · active not recruiting
- NCT06793085 — Pro- and Anti-inflammatory Cytokines in PCOS · recruiting
Other Peking University First Hospital trials
Trials by the same sponsor.
- NCT07498907 — Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelia · Phase 2 · not yet recruiting
- NCT07517276 — TUDCA in High-Risk Lactating Mothers Identified by Early Postpartum Milk Hydrophobicity Index · Phase 2 · not yet recruiting
- NCT07504939 — Multimodal Kidney-Sparing Strategy for High-Risk Upper Tract Urothelial Carcinoma · not yet recruiting
- NCT07464119 — A Clinical Study of iPSC-Derived Islet Cells for Diabetes Mellitus Therapy · NA · not yet recruiting
- NCT07460843 — Comparison of TB+PB and TB+6SB for Prostate Cancer Diagnosis · NA · recruiting
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 NCT05702905 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Peking University First Hospital
- Last refreshed: 25 March 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/NCT05702905.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing