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NOT YET RECRUITING
NCT07136987
PHASE3

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

Sponsor: Open Source Pharma Foundation

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

1104

Start Date

2026-01

Completion Date

2031-07

Last Updated

2025-08-22

Healthy Volunteers

No

Conditions

Interventions

DRUG

Metformin

Metformin 500 mg QAM x 1 wk, then 500 mg BID x 1 wk, then 1000 mg QAM and 500 mg QPM, plus standard TB treatment

DIETARY_SUPPLEMENT

N-Acetylcysteine (NAC) Treatment

N-acetylcysteine (NAC) 1800 mg orally twice daily plus standard TB treatment

COMBINATION_PRODUCT

Standard TB treatment

Standard TB treatment