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NCT05929495
Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma
Phase 2 trial testing Metformin in Glioblastoma, IDH-wildtype in 25 participants. Currently enrolling.
1 January 2026
Quick facts
| Lead sponsor | University of Milano Bicocca |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 12 February 2024 |
| Primary completion | 1 January 2026 |
| Estimated completion | 1 January 2026 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Metformin (metformin) — full drug profile →
Conditions studied
- Glioblastoma, IDH-wildtype — all drugs for Glioblastoma, IDH-wildtype →
- Metformin — all drugs for Metformin →
- Malignancies — all drugs for Malignancies →
Sponsor
University of Milano Bicocca
Who can join
18 and older, any sex, with Glioblastoma, IDH-wildtype or Metformin. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
About 75% of CNS malignant tumors are classified as gliomas and the IDH-wildtype glioblastoma (GBM) represents the most aggressive form among CNS malignancies. This is a nationwide single-center phase II drug clinical trial with an approximate duration of 32 months. The clinical trial will be single-arm to evaluate the biological activity and effects of metformin in combination with TMZ in patients with GBM.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Metformin: A Dual-Role Player in Cancer Treatment and Prevention.
Galal MA, Al-Rimawi M, Hajeer A, Dahman H, et al · · 2024 · cited 44× · PMID 38612893 · DOI 10.3390/ijms25074083 -
Drug Repurposing for Cancer Treatment: A Comprehensive Review.
Al Khzem AH, Gomaa MS, Alturki MS, Tawfeeq N, et al · · 2024 · cited 24× · PMID 39596504 · DOI 10.3390/ijms252212441 -
Advances in Anti-Cancer Drug Development: Metformin as Anti-Angiogenic Supplemental Treatment for Glioblastoma.
Shah S, Mansour HM, Aguilar TM, Lucke-Wold B. · · 2024 · cited 16× · PMID 38891882 · DOI 10.3390/ijms25115694 -
Multivariate analysis of metabolic state vulnerabilities across diverse cancer contexts reveals synthetically lethal associations.
Abecunas C, Kidd AD, Jiang Y, Zong H, et al · · 2024 · cited 6× · PMID 39305483 · DOI 10.1016/j.celrep.2024.114775 -
Metabolic adaptation of myeloid cells in the glioblastoma microenvironment.
Essakhi N, Bertucci A, Baeza-Kallee N, Colin C, et al · · 2024 · cited 4× · PMID 39763643 · DOI 10.3389/fimmu.2024.1431112 -
Targeting the Mitochondria in High-Grade Gliomas.
Sathe S, Li Q, Jung J, Wu J. · · 2025 · cited 2× · PMID 41008904 · DOI 10.3390/cancers17183062 -
Targeting tumor dormancy: the next frontier in gastrointestinal stromal tumor therapy.
Wu S, Liu H, Yin Y, Li J, et al · · 2026 · PMID 41955967 · DOI 10.1016/j.neo.2026.101306 -
Metformin Suppresses Glioblastoma Tumor Growth and Progression Through the AMPK/FoxO3a/Survivin Axis.
Cavaliere F, Pellegrino M, Cormace A, Spadafora S, et al · · 2026 · PMID 41677673 · DOI 10.3390/cells15030310
Verify or expand the search:
- PubMed search for NCT05929495
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Glioblastoma, IDH-wildtype
Currently open trials in the same condition.
- NCT06419946 — Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma · Phase 3 · recruiting
- NCT06327451 — Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma · Phase 2 · recruiting
- NCT06418113 — Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma · Phase 1 · recruiting
- NCT05941234 — Stem Cell Analysis, Omics (Including Immunomics) and Artificial Intelligence in Glioblastoma · NA · recruiting
- NCT06047379 — Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis · Phase 1, PHASE2 · recruiting
Other University of Milano Bicocca trials
Trials by the same sponsor.
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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 NCT05929495 (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 Milano Bicocca
- Last refreshed: 25 July 2025
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/NCT05929495.
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