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NCT05929495

Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma

Recruiting now Phase 2 Last updated 25 July 2025
What this trial tests

Phase 2 trial testing Metformin in Glioblastoma, IDH-wildtype in 25 participants. Currently enrolling.

Timeline
12 February 2024
Primary endpoint
1 January 2026
1 January 2026

Quick facts

Lead sponsorUniversity of Milano Bicocca
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment25
Start date12 February 2024
Primary completion1 January 2026
Estimated completion1 January 2026
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. Targeting the Mitochondria in High-Grade Gliomas.
    Sathe S, Li Q, Jung J, Wu J. · · 2025 · cited 2× · PMID 41008904 · DOI 10.3390/cancers17183062
  7. 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
  8. 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:

Other trials of Metformin

Trials testing the same drug.

Other recruiting trials for Glioblastoma, IDH-wildtype

Currently open trials in the same condition.

Other University of Milano Bicocca trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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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