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

NCT07136987 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1104

Last updated 2025-08-22

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • National Institute for Research in Tuberculosis, Chennai, India

    collaborator UNKNOWN

  • Open Source Pharma Foundation

    lead OTHER

Principal Investigators

  • Robert Wallis, MD · OSPF and Aurum Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2031-01-31
Completion
2031-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07136987 on ClinicalTrials.gov