Trial Outcomes & Findings for Phase 2 Trial Assessing TBAJ876 or Bedaquiline, With Pretomanid and Linezolid in Adults With Drug-sensitive Pulmonary Tuberculosis (NCT NCT06058299)

Last Updated: 2026-06-24

Results Overview

Kaplan Meir estimates of proportion participants with stable sputum culture conversion (SCCC) to negative by 8 weeks of treatment.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

309 participants

Primary outcome timeframe

Through 8 weeks of treatment

Results posted on

2026-06-24

Participant Flow

The first participant was screened on 24-Oct-2023, randomized 31 Oct 2023 and the final participant was randomized 30 Aug 2024. Participants were recruited from TB clinics,.

There were no randomized participants who were excluded before assignment to groups.

Participant milestones

Participant milestones
Measure	TBAJ876 25 mg + Pretomanid 200 mg + Linezolid 600 mg for 8 Weeks Followed by HR for 7 to 18 Weeks TBAJ876 25 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks (HR treatment length dependent on participant culture status at week 8 and presence or absence of TB symptoms). TBAJ-876: one 25 mg tablet Pretomanid: one 200 mg Linezolid: one 600 mg HR: Isoniazid (H) + rifampicin (R) fixed dose combination tablets dosed by weight	TBAJ876 50 mg + Pretomanid 200 mg + Linezolid 600 mg for 8 Weeks Followed by HR for 7 to 18 Weeks TBAJ876 50 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks TBAJ-876: two 25mg tablets Pretomanid: one 200 mg tablet Linezolid: one 600 mg tablet HR: Isoniazid (H) + rifampicin (R) fixed dose combination tablets dosed by weight	TBAJ876 100 mg + Pretomanid 200 mg + Linezolid 600 mg for 8 Weeks Followed by HR for 7 to 18 Weeks TBAJ876 100 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks (HR treatment length dependent on participant culture status at week 8 and presence or absence of TB symptoms). TBAJ-876: four 25mg tablets Pretomanid: one 200 mg tablet Linezolid: one 600 mg tablet HR: Isoniazid (H) + rifampicin (R) fixed dose combination tablets dosed by weight	Bedaquiline 200 mg + Pretomanid 200 mg + Linezolid 600 mg for 8 Weeks Followed by Bedaquiline 100 mg Bedaquiline 200 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by bedaquiline 100 mg + pretomanid 200 mg + linezolid 600 mg for 18 weeks Pretomanid: 200 mg tablet Linezolid: 600 mg tablet Bedaquiline: two 100 mg tablets for 8 weeks followed by 100 mg tablet for 18 weeks	Isoniazid (H) + Rifampicin (R) + Pyrazinamide (Z), Ethambutol (E) for 8 Weeks Then HR for 18 Weeks Isoniazid (H) + rifampicin (R) + pyrazinamide (Z), ethambutol (E) for 8 weeks followed by HR for 18 weeks (dose based on participant's weight). HRZE: Isoniazid (H) + rifampicin (R) + pyrazinamide (Z) plus ethambutol (E) fixed dose combination tablets dosed by weight HR: Isoniazid (H) + rifampicin (R) fixed dose combination tablets dosed by weight
Week 8 Interim Analysis STARTED	61	64	61	63	60
Week 8 Interim Analysis COMPLETED	60	63	60	61	57
Week 8 Interim Analysis NOT COMPLETED	1	1	1	2	3
52 Weeks Follow-up STARTED	60	63	60	61	57
52 Weeks Follow-up COMPLETED	0	0	0	0	0
52 Weeks Follow-up NOT COMPLETED	60	63	60	61	57

Reasons for withdrawal

Reasons for withdrawal
Measure	TBAJ876 25 mg + Pretomanid 200 mg + Linezolid 600 mg for 8 Weeks Followed by HR for 7 to 18 Weeks TBAJ876 25 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks (HR treatment length dependent on participant culture status at week 8 and presence or absence of TB symptoms). TBAJ-876: one 25 mg tablet Pretomanid: one 200 mg Linezolid: one 600 mg HR: Isoniazid (H) + rifampicin (R) fixed dose combination tablets dosed by weight	TBAJ876 50 mg + Pretomanid 200 mg + Linezolid 600 mg for 8 Weeks Followed by HR for 7 to 18 Weeks TBAJ876 50 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks TBAJ-876: two 25mg tablets Pretomanid: one 200 mg tablet Linezolid: one 600 mg tablet HR: Isoniazid (H) + rifampicin (R) fixed dose combination tablets dosed by weight	TBAJ876 100 mg + Pretomanid 200 mg + Linezolid 600 mg for 8 Weeks Followed by HR for 7 to 18 Weeks TBAJ876 100 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks (HR treatment length dependent on participant culture status at week 8 and presence or absence of TB symptoms). TBAJ-876: four 25mg tablets Pretomanid: one 200 mg tablet Linezolid: one 600 mg tablet HR: Isoniazid (H) + rifampicin (R) fixed dose combination tablets dosed by weight	Bedaquiline 200 mg + Pretomanid 200 mg + Linezolid 600 mg for 8 Weeks Followed by Bedaquiline 100 mg Bedaquiline 200 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by bedaquiline 100 mg + pretomanid 200 mg + linezolid 600 mg for 18 weeks Pretomanid: 200 mg tablet Linezolid: 600 mg tablet Bedaquiline: two 100 mg tablets for 8 weeks followed by 100 mg tablet for 18 weeks	Isoniazid (H) + Rifampicin (R) + Pyrazinamide (Z), Ethambutol (E) for 8 Weeks Then HR for 18 Weeks Isoniazid (H) + rifampicin (R) + pyrazinamide (Z), ethambutol (E) for 8 weeks followed by HR for 18 weeks (dose based on participant's weight). HRZE: Isoniazid (H) + rifampicin (R) + pyrazinamide (Z) plus ethambutol (E) fixed dose combination tablets dosed by weight HR: Isoniazid (H) + rifampicin (R) fixed dose combination tablets dosed by weight
Week 8 Interim Analysis Withdrawal by Subject	0	0	0	1	1
Week 8 Interim Analysis Adverse Event	0	0	0	1	0
Week 8 Interim Analysis Death	0	0	1	0	0
Week 8 Interim Analysis Physician Decision	1	0	0	0	0
Week 8 Interim Analysis Lost to Follow-up	0	1	0	0	0
Week 8 Interim Analysis Missed > 14 doses	0	0	0	0	1
Week 8 Interim Analysis Participant was randomized and did not receive IMP as site realized they Has DR-TB (exclusion) as	0	0	0	0	1

Baseline Characteristics

Phase 2 Trial Assessing TBAJ876 or Bedaquiline, With Pretomanid and Linezolid in Adults With Drug-sensitive Pulmonary Tuberculosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TBAJ876 25 mg n=61 Participants TBAJ876 25 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks TBAJ-876: one 25 mg tablet Pretomanid: 200 mg Linezolid: 600 mg HR: Isoniazid (H) + rifampicin (R) fixed dose combination tablets dosed by weight	TBAJ876 50 mg n=64 Participants TBAJ876 50 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks TBAJ-876: two 25mg tablets Pretomanid: 200 mg Linezolid: 600 mg HR: Isoniazid (H) + rifampicin (R) fixed dose combination tablets dosed by weight	TBAJ876 100 mg n=61 Participants TBAJ876 100 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks TBAJ-876: four 25mg tablets Pretomanid: 200 mg Linezolid: 600 mg HR: Isoniazid (H) + rifampicin (R) fixed dose combination tablets dosed by weight	BPaL n=63 Participants Bedaquiline 200 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by bedaquiline 100 mg + pretomanid 200 mg + linezolid 600 mg for 18 weeks Pretomanid: 200 mg Linezolid: 600 mg Bedaquiline: 200 mg for 8 weeks followed by 100 mg for 18 weeks	2HRZE/4HR n=59 Participants Isoniazid (H) + rifampicin (R) + pyrazinamide (Z), ethambutol (E) for 8 weeks followed by HR for 18 weeks (dose based on participant's weight). HRZE: Isoniazid (H) + rifampicin (R) + pyrazinamide (Z) plus ethambutol (E) fixed dose combination tablets dosed by weight HR: Isoniazid (H) + rifampicin (R) fixed dose combination tablets dosed by weight	Total n=308 Participants Total of all reporting groups
Age, Continuous	33.2 years STANDARD_DEVIATION 9.70 • n=20 Participants	36.1 years STANDARD_DEVIATION 10.59 • n=20 Participants	32.6 years STANDARD_DEVIATION 10.47 • n=40 Participants	34.1 years STANDARD_DEVIATION 11.01 • n=6 Participants	36.8 years STANDARD_DEVIATION 11.11 • n=7 Participants	34.6 years STANDARD_DEVIATION 10.64 • n=13 Participants
Sex: Female, Male Female	20 Participants n=20 Participants	15 Participants n=20 Participants	19 Participants n=40 Participants	15 Participants n=6 Participants	11 Participants n=7 Participants	80 Participants n=13 Participants
Sex: Female, Male Male	41 Participants n=20 Participants	49 Participants n=20 Participants	42 Participants n=40 Participants	48 Participants n=6 Participants	48 Participants n=7 Participants	228 Participants n=13 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=20 Participants	59 Participants n=20 Participants	54 Participants n=40 Participants	59 Participants n=6 Participants	55 Participants n=7 Participants	280 Participants n=13 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=20 Participants	5 Participants n=20 Participants	7 Participants n=40 Participants	4 Participants n=6 Participants	4 Participants n=7 Participants	28 Participants n=13 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants
Race (NIH/OMB) Asian	1 Participants n=20 Participants	3 Participants n=20 Participants	1 Participants n=40 Participants	2 Participants n=6 Participants	1 Participants n=7 Participants	8 Participants n=13 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants
Race (NIH/OMB) Black or African American	52 Participants n=20 Participants	53 Participants n=20 Participants	49 Participants n=40 Participants	53 Participants n=6 Participants	51 Participants n=7 Participants	258 Participants n=13 Participants
Race (NIH/OMB) White	3 Participants n=20 Participants	3 Participants n=20 Participants	4 Participants n=40 Participants	3 Participants n=6 Participants	2 Participants n=7 Participants	15 Participants n=13 Participants
Race (NIH/OMB) More than one race	5 Participants n=20 Participants	5 Participants n=20 Participants	7 Participants n=40 Participants	5 Participants n=6 Participants	5 Participants n=7 Participants	27 Participants n=13 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=13 Participants
Region of Enrollment Georgia	3 Participants n=20 Participants	3 Participants n=20 Participants	4 Participants n=40 Participants	3 Participants n=6 Participants	2 Participants n=7 Participants	15 Participants n=13 Participants
Region of Enrollment Philippines	1 Participants n=20 Participants	3 Participants n=20 Participants	1 Participants n=40 Participants	2 Participants n=6 Participants	1 Participants n=7 Participants	8 Participants n=13 Participants
Region of Enrollment South Africa	33 Participants n=20 Participants	33 Participants n=20 Participants	32 Participants n=40 Participants	32 Participants n=6 Participants	32 Participants n=7 Participants	162 Participants n=13 Participants
Region of Enrollment Tanzania	15 Participants n=20 Participants	16 Participants n=20 Participants	16 Participants n=40 Participants	17 Participants n=6 Participants	15 Participants n=7 Participants	79 Participants n=13 Participants
Region of Enrollment Uganda	9 Participants n=20 Participants	9 Participants n=20 Participants	8 Participants n=40 Participants	9 Participants n=6 Participants	9 Participants n=7 Participants	44 Participants n=13 Participants

PRIMARY outcome

Timeframe: Through 8 weeks of treatment

Population: mITT population excludes participants with to determine inclusion If Day 1 sputum is contaminated or unavailable or a lack of MTB culture positive on Day 1, Screening culture can be used OR myco discrepancies revealing drug-resistant TB (DR-TB)

Kaplan Meir estimates of proportion participants with stable sputum culture conversion (SCCC) to negative by 8 weeks of treatment.

Outcome measures

Outcome measures
Measure	TBAJ876 25 mg n=58 Participants TBAJ876 25 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks TBAJ-876: one 25 mg tablet Pretomanid: 200 mg Linezolid: 600 mg HR: Isoniazid (H) + rifampicin (R) fixed dose combination tablets dosed by weight	TBAJ876 50 mg n=64 Participants TBAJ876 50 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks TBAJ-876: two 25mg tablets Pretomanid: 200 mg Linezolid: 600 mg HR: Isoniazid (H) + rifampicin (R) fixed dose combination tablets dosed by weight	TBAJ876 100 mg n=60 Participants TBAJ876 100 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks TBAJ-876: four 25mg tablets Pretomanid: 200 mg Linezolid: 600 mg HR: Isoniazid (H) + rifampicin (R) fixed dose combination tablets dosed by weight	BPaL n=63 Participants Bedaquiline 200 mg + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by bedaquiline 100 mg + pretomanid 200 mg + linezolid 600 mg for 18 weeks Pretomanid: 200 mg Linezolid: 600 mg Bedaquiline: 200 mg for 8 weeks followed by 100 mg for 18 weeks	2HRZE/4HR n=59 Participants Isoniazid (H) + rifampicin (R) + pyrazinamide (Z), ethambutol (E) for 8 weeks followed by HR for 18 weeks (dose based on participant's weight). HRZE: Isoniazid (H) + rifampicin (R) + pyrazinamide (Z) plus ethambutol (E) fixed dose combination tablets dosed by weight HR: Isoniazid (H) + rifampicin (R) fixed dose combination tablets dosed by weight
Proportion of Participants With Stable Sputum Conversion by 8 Weeks,	0.310 proportion of participants Interval 0.208 to 0.446	0.476 proportion of participants Interval 0.362 to 0.606	0.593 proportion of participants Interval 0.472 to 0.718	0.452 proportion of participants Interval 0.338 to 0.583	0.449 proportion of participants Interval 0.332 to 0.585

SECONDARY outcome

Timeframe: 26 weeks after end of treatment

Proportion of participants with a favorable outcome at 26 weeks after the end of treatment.

Outcome measures

Outcome data not reported

Adverse Events

TBAJ876 25 Mg-Pa-L

Serious events: 2 serious events

Other events: 39 other events

Deaths: 0 deaths

TBAJ876 50 Mg-Pa-L

Serious events: 1 serious events

Other events: 40 other events

Deaths: 0 deaths

TBAJ876 100 Mg-Pa-L

Serious events: 3 serious events

Other events: 36 other events

Deaths: 1 deaths

B-Pa-L

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

HRZE/HR

Serious events: 1 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TBAJ876 25 Mg-Pa-L n=61 participants at risk Participants take TBAJ876 25 mg tablets orally once a day + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks.	TBAJ876 50 Mg-Pa-L n=64 participants at risk Participants take TBAJ876 50 mg tablets orally once a day + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks.	TBAJ876 100 Mg-Pa-L n=61 participants at risk Participants take TBAJ876 100 mg tablets orally once a day + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks.	B-Pa-L n=63 participants at risk Participants take Bedaquiline 200 mg tablets orally once a day + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by bedaquiline 100 mg tablets orally once a day + pretomanid 200 mg + linezolid 600 mg for 18 weeks.	HRZE/HR n=59 participants at risk Participants take Isoniazid (H) + rifampicin (R) + pyrazinamide (Z), ethambutol (E) for 8 weeks followed by HR for 18 weeks (dose based on participantΓÇÖs weight).
Gastrointestinal disorders Intussusception	1.6% 1/61 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/64 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/61 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/63 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/59 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/61 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/64 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.6% 1/61 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/63 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/59 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Infections and infestations Pneumonia	0.00% 0/61 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/64 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.6% 1/61 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/63 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/59 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Infections and infestations Respiratory tract infection	1.6% 1/61 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/64 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/61 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/63 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/59 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/61 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.6% 1/64 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/61 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/63 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/59 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Psychiatric disorders Mental status changes	0.00% 0/61 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/64 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/61 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/63 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.7% 1/59 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/61 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/64 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.6% 1/61 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/63 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/59 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.

Other adverse events

Other adverse events
Measure	TBAJ876 25 Mg-Pa-L n=61 participants at risk Participants take TBAJ876 25 mg tablets orally once a day + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks.	TBAJ876 50 Mg-Pa-L n=64 participants at risk Participants take TBAJ876 50 mg tablets orally once a day + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks.	TBAJ876 100 Mg-Pa-L n=61 participants at risk Participants take TBAJ876 100 mg tablets orally once a day + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by HR for 7 to 18 weeks.	B-Pa-L n=63 participants at risk Participants take Bedaquiline 200 mg tablets orally once a day + pretomanid 200 mg + linezolid 600 mg for 8 weeks followed by bedaquiline 100 mg tablets orally once a day + pretomanid 200 mg + linezolid 600 mg for 18 weeks.	HRZE/HR n=59 participants at risk Participants take Isoniazid (H) + rifampicin (R) + pyrazinamide (Z), ethambutol (E) for 8 weeks followed by HR for 18 weeks (dose based on participantΓÇÖs weight).
Gastrointestinal disorders Diarrhoea	11.5% 7/61 • Number of events 7 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	9.4% 6/64 • Number of events 6 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	6.6% 4/61 • Number of events 4 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.6% 1/63 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	10.2% 6/59 • Number of events 6 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Gastrointestinal disorders Dyspepsia	4.9% 3/61 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.1% 2/64 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	4.9% 3/61 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	6.3% 4/63 • Number of events 5 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/59 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Gastrointestinal disorders Vomiting	1.6% 1/61 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.6% 1/64 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.3% 2/61 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	6.3% 4/63 • Number of events 4 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	10.2% 6/59 • Number of events 7 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
General disorders Fatigue	1.6% 1/61 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/64 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/61 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/63 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	5.1% 3/59 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Hepatobiliary disorders Hyperbilirubinaemia	1.6% 1/61 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	6.2% 4/64 • Number of events 4 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	6.6% 4/61 • Number of events 4 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.2% 2/63 • Number of events 4 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.4% 2/59 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Infections and infestations Gastroenteritis	0.00% 0/61 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.1% 2/64 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.6% 1/61 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.6% 1/63 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	6.8% 4/59 • Number of events 5 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Infections and infestations Upper respiratory tract infection	16.4% 10/61 • Number of events 10 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.1% 2/64 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	4.9% 3/61 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	7.9% 5/63 • Number of events 7 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	13.6% 8/59 • Number of events 11 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Investigations Alanine aminotransferase increased	1.6% 1/61 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.1% 2/64 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	11.5% 7/61 • Number of events 10 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/63 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.7% 1/59 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Investigations Amylase increased	3.3% 2/61 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	6.2% 4/64 • Number of events 4 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	8.2% 5/61 • Number of events 5 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	7.9% 5/63 • Number of events 5 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.7% 1/59 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Investigations Aspartate aminotransferase increased	4.9% 3/61 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/64 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	9.8% 6/61 • Number of events 7 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.6% 1/63 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	5.1% 3/59 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Investigations Blood bicarbonate decreased	1.6% 1/61 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.1% 2/64 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	9.8% 6/61 • Number of events 8 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	7.9% 5/63 • Number of events 5 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.4% 2/59 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Metabolism and nutrition disorders Gout	0.00% 0/61 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/64 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/61 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/63 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	5.1% 3/59 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Metabolism and nutrition disorders Hyperamylasaemia	9.8% 6/61 • Number of events 10 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	12.5% 8/64 • Number of events 8 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	8.2% 5/61 • Number of events 5 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	7.9% 5/63 • Number of events 9 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	5.1% 3/59 • Number of events 4 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/61 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.6% 1/64 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	8.2% 5/61 • Number of events 5 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.6% 1/63 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.7% 1/59 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Metabolism and nutrition disorders Hyperuricaemia	4.9% 3/61 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.6% 1/64 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	4.9% 3/61 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.2% 2/63 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	37.3% 22/59 • Number of events 23 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Metabolism and nutrition disorders Hypomagnesaemia	3.3% 2/61 • Number of events 5 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.1% 2/64 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.3% 2/61 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.2% 2/63 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	5.1% 3/59 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Metabolism and nutrition disorders Hyponatraemia	3.3% 2/61 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	12.5% 8/64 • Number of events 11 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	4.9% 3/61 • Number of events 4 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	7.9% 5/63 • Number of events 6 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.7% 1/59 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Metabolism and nutrition disorders Metabolic acidosis	3.3% 2/61 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	10.9% 7/64 • Number of events 9 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.6% 1/61 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.2% 2/63 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	5.1% 3/59 • Number of events 4 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Musculoskeletal and connective tissue disorders Arthralgia	1.6% 1/61 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.1% 2/64 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.3% 2/61 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.6% 1/63 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	13.6% 8/59 • Number of events 10 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.00% 0/61 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/64 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/61 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/63 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	5.1% 3/59 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Nervous system disorders Dizziness	4.9% 3/61 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	4.7% 3/64 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.3% 2/61 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.2% 2/63 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	5.1% 3/59 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Nervous system disorders Headache	11.5% 7/61 • Number of events 8 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	6.2% 4/64 • Number of events 4 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	4.9% 3/61 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	4.8% 3/63 • Number of events 4 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	6.8% 4/59 • Number of events 4 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Nervous system disorders Peripheral sensory neuropathy	3.3% 2/61 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	6.2% 4/64 • Number of events 4 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	4.9% 3/61 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	7.9% 5/63 • Number of events 5 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	10.2% 6/59 • Number of events 6 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	3.3% 2/61 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/64 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.3% 2/61 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/63 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	5.1% 3/59 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Skin and subcutaneous tissue disorders Acne	6.6% 4/61 • Number of events 4 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.6% 1/64 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/61 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/63 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/59 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Skin and subcutaneous tissue disorders Pruritus	13.1% 8/61 • Number of events 9 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	4.7% 3/64 • Number of events 4 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	4.9% 3/61 • Number of events 3 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.2% 2/63 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	6.8% 4/59 • Number of events 4 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Skin and subcutaneous tissue disorders Rash papular	8.2% 5/61 • Number of events 5 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	4.7% 3/64 • Number of events 4 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	8.2% 5/61 • Number of events 5 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.6% 1/63 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	0.00% 0/59 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.
Vascular disorders Hypertension	6.6% 4/61 • Number of events 4 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.6% 1/64 • Number of events 1 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.3% 2/61 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	3.2% 2/63 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.	1.7% 1/59 • Number of events 2 • 8 Weeks of treatment (data entered for 8 week interim analysis and all AE data at time of data cut-off, 30 Jan 2025). All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of study drug up to and including 28 days after the last study drug administration. The data presented currently includes AEs through the data cut-off for the week 8 analysis.

Additional Information

Mourounfolu Olugbosi

TB Alliance

Phone: +27 79 045 4917

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The results of this trial may be published or presented at scientific meetings. If this is foreseen, the investigator agrees to submit all manuscripts or abstracts to TB Alliance before submission. This allows TB Alliance to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER