Please sign in to follow a disease.
New TB drug cocktail shows promise in early trial
NCT ID NCT05382312
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested an experimental drug called GSK3036656 in combination with other tuberculosis medications in 127 adults with newly diagnosed, drug-sensitive pulmonary TB. Participants received one of several two-drug combinations or standard care for 14 days, then switched to standard treatment. The goal was to measure how quickly the combinations killed TB bacteria in sputum and to check for safety and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GSK3036656 (an experimental drug) combined with other tuberculosis drugs (bedaquiline, delamanid, BTZ-043, pretomanid, linezolid, moxifloxacin) or standard care
- What this could lead to
- If successful, this could point toward shorter, more effective treatment combinations for drug-sensitive tuberculosis.
- What could go wrong
- This is an early Phase 2A trial with only 127 participants and a short 14-day treatment period. Results may not translate to long-term cure or apply to all TB patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
127 people
The number who actually took part.
- Started
-
Jul 2022
- Finished
-
May 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants were 18 to 65 years of age inclusive, at the time of signing the informed consent. * Participants had: 1. A new episode of untreated, rifampicin-susceptible pulmonary tuberculosis (TB) 2. A chest X-ray picture consistent with pulmonary TB 3. At least one sputum sample positive on direct microscopy for acid-fast bacilli (at least 1+ on the International Union Against Tuberculosis and Lung Disease \[IUATLD\]/World Health Organization \[WHO\] scale) or positive on a molecular test (at least medium positive for MTB on Xpert MTB/Rif) 4. A normal echocardiogram, or an echocardiogram with normal left ventricular function with at most trace to mild valvular regurgitation, and no valvular stenosis 5. A creatinine clearance greater than or equal to (\>=) 90 mL/minute (Cockcroft-Gault formula) * Male participants were eligible to participate if they agreed to barrier precautions until 90 days after the last dose. * A female participant was eligible to participate if she was not pregnant or breastfeeding and was a woman of non-childbearing potential (WONCBP) or a woman of childbearing potential (WOCBP) using a highly effective contraceptive method. A WOCBP had to have a negative urine or serum pregnancy test, as required by local regulations, before the first dose of study intervention. Only participants who were at least 25 years of age, and females of non-childbearing potential, were eligible for the positron emission tomography-computed tomography (PET-CT) assessments. * Participants were capable of giving signed informed consent. Exclusion Criteria: * There was evidence of a clinically significant condition or abnormality (as judged by the Investigator) (other than the indication being studied) that might have compromised safety or the interpretation of trial efficacy or safety endpoints. * There was clinically significant evidence of extrathoracic TB, as judged by the Investigator. * QTc interval corrected for heart rate by Fridericia's formula (QTcF) was greater than (\>) 450 milliseconds (msec). * There was arterial hypertension with systolic BP \>=160 mm Hg or diastolic BP \>=100 mm Hg. Participants with well-controlled hypertension could be included if they were using amlodipine for the duration of the study. * Participants had vitiligo. * Participants were receiving QT-prolonging drugs, including but not limited to fluoroquinolones, macrolides, and clofazimine. * HIV-infected participants who: 1. had a cluster of differentiation (CD)4+ count \<350 cells/microliters; 2. had received antiretroviral therapy medication within the last 30 days; 3. had received oral or intravenous antifungal medication within the last 30 days; 4. or had an acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection or malignancy in the last 12 months (except pulmonary TB). * Hepatitis B surface antigen (HBsAg) was present, or the Hepatitis C antibody test result at screening was positive. * Participants had diabetes (Type 1 or 2), point-of-care glycated hemoglobin (HbA1c) above 6.5%, or random glucose over 11.1 millimoles (mmol)/L. * There were diseases or conditions in which the use of delamanid or bedaquiline was contraindicated. * Participants had abnormal laboratory values at screening, as graded by the enhanced Common Terminology Criteria for Adverse Events (CTCAE version 5, 2017).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Tuberculosis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
GSK Investigational Site
Bellville, 7530, South Africa
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Once-Daily HIV pill with food match Twice-Daily dosing during TB treatment?
- Can simple sputum and urine tests catch tuberculosis earlier?
- Can a common virus be turned into a TB vaccine? scientists test VIR-1778
- Fish oil meets TB drugs: can Omega-3 help clear infection faster?
- Can starting TB treatment immediately save lives in HIV sepsis?
- Can a 4-Drug combo cut TB treatment time in half?