Safety and Tolerability of systemic administration of metformin in patients with Idiopathic Pulmonary Fibrosis (IPF): A randomized, placebo-controlled, double-blind, phase II proof-of-concept study (Met_for_IPF)
interventional
N/A
1 country
3
The primary objective is to evaluate the effect of metformin compared to placebo on the change in PRO-C3 from randomization until the end of the 12-weeks treatment period
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 6, 2026
Actual (reported)The primary endpoint is the mean difference in the absolute change from baseline in PRO-C3 release in serum (∆ PRO-C3) between both treatment groups as determined from the analysis of covariance (ANCOVA) model adjusting for baseline differences
Assessment of ∆ PRO-C3 between both treatment groups from randomization until the end of the follow-up period in accordance with the method used for assessment of the primary endpoint (see above).
Assessment of lung mechanics: Change in lung function over time: IVC, RV, IC, FEV1, FVC, TLC, sRaw effect and FEV1/FVC ratio
Assessment of exercise capacity and gas exchange over time : Change in exercise capacity: 6-minute walking test (6MWT) Change in partial pressure of O2 (pO2), change in O2 saturation between rest and exercise (at the end of the 6MWT), of CO2 (pCO2) Change in gas exchange: diffusion capacity for CO (DLCO, KCO)
Assessment of changes in PRO-C6, C3M-HP, VICM, hsPRO-C4, CTX-III, SP-D, PAI-1 over time
Assessment of toxicity and safety during the course of the study until 4 weeks after the last dose of the medication: AEs, SAEs
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Thoraxklinik Heidelberg gGmbH
Heidelberg, 69126, Germany
Justus-Liebig-Universitaet Giessen
Giessen, 35392, Germany
LMU Klinikum Muenchen AöR
Munich, 81377, Germany
Project manager
First Submitted
August 6, 2026
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