A Randomized Controlled Trial of 2 Disease-Modifying Drugs (Metformin and N-acetylcysteine ) to Promote TB Lung Function Recovery (TB-MET-NAC)

NCT07136987 Phase 3 NOT_YET_RECRUITING

Tuberculosis is a leading global cause of morbidity and mortality. Even if cured, a majority patients are left with bronchiectasis and fibrosis, permanent conditions that impair lung function. Large cohort studies have confirmed that even modest loss of lung function is associated with excess mortality risk. This study will examine if two treatments, metformin and N-acetylcysteine (NAC), can promote the recovery of lung function in TB if given together with standard TB treatment. There currently are no drugs approved for this indication.

Details

Lead sponsor	Open Source Pharma Foundation
Phase	Phase 3
Status	NOT_YET_RECRUITING
Enrolment	1104
Start date	2026-01
Completion	2031-07

Conditions

• Tuberculosis

Interventions

• Metformin
• N-Acetylcysteine (NAC) Treatment
• Standard TB treatment

Primary outcomes

• FEV1 — month 18
  FEV1 after adjustment for baseline covariates including FEV1, in a superiority comparison
• Favourable treatment outcome — 18 months
  Proportion of participants achieving a favourable treatment outcome (other than death, failure, recurrence, loss, default) in a non-inferiority comparison