Phase 2Not yet recruitingAge-related condition
Study of safety and tolerability following administration of metformin in patients with idiopathic pulmonary fibrosis (IPF) (KKS-329)
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)
- Sponsor
- Philipps-Universitaet Marburg (Industry)
- Enrollment
- 40 planned
- Conditions
- Idiopathic pulmonary fibrosis
- Interventions
- P-Tabletten weiß 7 mm Lichtenstein; Metformin-ratiopharm 500 mg Filmtabletten
- Ages
- adults, older adults
- Registry
- CTIS2025-523341-10-00
Full record on the EU Clinical Trials Information System
From the registry
Main objective: 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
Primary outcomes
- 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
History
Registered