Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis

Metformin · Фаза 3

ID реестра
NCT07520110
Фаза
Фаза 3
Статус
Набор еще не начат
Препарат / вмешательство
Metformin
Спонсор
University of Massachusetts, Worcester
Набор участников
800
Центры
15

Об исследовании

This is a randomized, placebo-controlled trial of metformin in 400 participants with idiopathic pulmonary fibrosis (IPF) who are at high risk of adverse clinical outcomes based on a proteomic classifier. The primary objective is to assess the safety and efficacy of metformin compared to placebo in participants with IPF who are at high-risk for adverse clinical events. Approximately 800 participants with IPF will be screened. 400 participants who are at high risk for adverse clinical events (proteomic signature present) will be randomized into receiving metformin (n\~200) or matching placebo (n\~200). Participants that meet the eligibility criteria but do not have the proteomic signature (proteomic signature absent) will be contacted by phone at 12 and 24 months to review medical history.

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