Trial Outcomes & Findings for Safety and Tolerability Study of Acoziborole in g-HAT Seropositive Subjects (NCT NCT05256017)

NCT ID: NCT05256017

Last Updated: 2025-03-20

Results Overview

Occurrence and excess rate (95% CI) of any TEAEs.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 1208 participants
• Primary outcome timeframe: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).
• Results posted on: 2025-03-20

Participant Flow

Participant milestones

Measure	Acoziborole Acoziborole: 3 tablets of 320 mg	Placebo Acoziborole matching placebo: 3 tablets of 320 mg
Treatment Period STARTED	907	301
Treatment Period COMPLETED	906	300
Treatment Period NOT COMPLETED	1	1
Follow-up STARTED	906	300
Follow-up COMPLETED	898	298
Follow-up NOT COMPLETED	8	2

Reasons for withdrawal

Measure	Acoziborole Acoziborole: 3 tablets of 320 mg	Placebo Acoziborole matching placebo: 3 tablets of 320 mg
Treatment Period Withdrawal by Subject	1	1
Follow-up Lost to Follow-up	7	1
Follow-up Withdrawal by Subject	1	0
Follow-up Death	0	1

Baseline Characteristics

Safety and Tolerability Study of Acoziborole in g-HAT Seropositive Subjects

Baseline characteristics by cohort

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Placebo: 3 tablets of 320 mg	Total n=1206 Participants Total of all reporting groups
Age, Continuous	37.3 years STANDARD_DEVIATION 17.35 • n=5 Participants	36.4 years STANDARD_DEVIATION 16.38 • n=7 Participants	37.1 years STANDARD_DEVIATION 17.11 • n=5 Participants
Age, Customized Adolescent (15-17 years)	101 Participants n=5 Participants	28 Participants n=7 Participants	129 Participants n=5 Participants
Age, Customized Adult (≥18 years)	805 Participants n=5 Participants	272 Participants n=7 Participants	1077 Participants n=5 Participants
Sex: Female, Male Female	476 Participants n=5 Participants	158 Participants n=7 Participants	634 Participants n=5 Participants
Sex: Female, Male Male	430 Participants n=5 Participants	142 Participants n=7 Participants	572 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	906 Participants n=5 Participants	300 Participants n=7 Participants	1206 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Guinea	132 Participants n=5 Participants	44 Participants n=7 Participants	176 Participants n=5 Participants
Region of Enrollment Republic of the Congo	774 Participants n=5 Participants	256 Participants n=7 Participants	1030 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Occurrence and excess rate (95% CI) of any TEAEs.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Occurrence of Any TEAEs	195 Participants	69 Participants

PRIMARY outcome

Timeframe: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Occurrence of TEAEs - Malaria	34 Participants	14 Participants

PRIMARY outcome

Timeframe: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Occurrence of TEAEs - Acarodermatitis	13 Participants	3 Participants

PRIMARY outcome

Timeframe: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Occurrence of TEAEs - Abdominal Pain	23 Participants	9 Participants

PRIMARY outcome

Timeframe: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Occurrence of TEAEs - Enteritis	7 Participants	4 Participants

PRIMARY outcome

Timeframe: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Occurrence of TEAEs - Nausea	7 Participants	3 Participants

PRIMARY outcome

Timeframe: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Occurrence of TEAEs - Gastritis	6 Participants	3 Participants

PRIMARY outcome

Timeframe: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Occurrence of TEAEs - Headache	53 Participants	8 Participants

PRIMARY outcome

Timeframe: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Occurrence of TEAEs - Fatigue	14 Participants	5 Participants

PRIMARY outcome

Timeframe: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Occurrence of TEAEs - Blood Potassium Increased	8 Participants	6 Participants

PRIMARY outcome

Timeframe: During hospitalization: from investigational product administration (Day 1) to Day 5 (End of Hospitalization); After hospitalization: from Day 5 (discharge) to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Occurrence and excess rate (95% CI) of any TEAEs, by period of occurrence.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Occurrence of TEAEs by Period of Occurrence During hospitalization	124 participants	38 participants
Occurrence of TEAEs by Period of Occurrence After hospitalization	106 participants	45 participants

PRIMARY outcome

Timeframe: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Occurrence and excess rate (95% CI) of any serious TEAEs.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Occurrence of Serious TEAEs	3 Participants	4 Participants

PRIMARY outcome

Timeframe: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Occurrence and excess rate (95% CI) of any serious TEAEs.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Occurrence of Severe Treatment-related TEAEs	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Occurrence of any treatment-related TEAEs by arm

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Occurrence of Any Treatment-related TEAEs	59 Participants	17 Participants

PRIMARY outcome

Timeframe: From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Occurrence of any treatment-related TEAEs by PT and by arm

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Occurrence of Treatment-related TEAEs by PT SOC: Nervous system disorders	28 Participants	5 Participants
Occurrence of Treatment-related TEAEs by PT Abdominal pain	14 Participants	6 Participants
Occurrence of Treatment-related TEAEs by PT Fatigue	8 Participants	5 Participants
Occurrence of Treatment-related TEAEs by PT Decreased appetite	6 Participants	1 Participants
Occurrence of Treatment-related TEAEs by PT Nausea	5 Participants	2 Participants
Occurrence of Treatment-related TEAEs by PT Dizziness	5 Participants	1 Participants
Occurrence of Treatment-related TEAEs by PT Hot flush	3 Participants	0 Participants
Occurrence of Treatment-related TEAEs by PT Pyrexia	2 Participants	0 Participants
Occurrence of Treatment-related TEAEs by PT Insomia	2 Participants	0 Participants
Occurrence of Treatment-related TEAEs by PT Vomiting	1 Participants	1 Participants
Occurrence of Treatment-related TEAEs by PT Dysgeusia	1 Participants	0 Participants
Occurrence of Treatment-related TEAEs by PT Diarrhoea	1 Participants	0 Participants
Occurrence of Treatment-related TEAEs by PT Enteritis	1 Participants	0 Participants
Occurrence of Treatment-related TEAEs by PT Dyspepsia	1 Participants	0 Participants
Occurrence of Treatment-related TEAEs by PT Gastrointestinal sounds abnormal	1 Participants	0 Participants
Occurrence of Treatment-related TEAEs by PT Asthenia	1 Participants	0 Participants
Occurrence of Treatment-related TEAEs by PT Electrocardiogram QT prolonged	1 Participants	0 Participants
Occurrence of Treatment-related TEAEs by PT Muscle spasms	1 Participants	0 Participants
Occurrence of Treatment-related TEAEs by PT Tachycardia	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From Inform Consent signature (up to 2 days before treatment) to the Month 4 follow up visit (End of Study)

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Occurrence of any Adverse Event from Inform Consent signature to 4 month follow-up visit.

Of note, all AEs reported during this study were TEAEs.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Occurrence of Adverse Events (AEs)	195 Participants	69 Participants

SECONDARY outcome

Timeframe: From baseline to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in Biochemistry Parameter: Alanine Aminotransferase Baseline	20.6 U/L Standard Deviation 7.90	20.6 U/L Standard Deviation 9.44
Change From Baseline in Biochemistry Parameter: Alanine Aminotransferase Day 5	21.9 U/L Standard Deviation 9.10	24.9 U/L Standard Deviation 13.42
Change From Baseline in Biochemistry Parameter: Alanine Aminotransferase Month 1	19.2 U/L Standard Deviation 7.87	19.5 U/L Standard Deviation 11.70
Change From Baseline in Biochemistry Parameter: Alanine Aminotransferase Month 4	20.8 U/L Standard Deviation 8.05	20.0 U/L Standard Deviation 6.71

SECONDARY outcome

Timeframe: From baseline to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in Biochemistry Parameter: Albumin Baseline	3.22 g/dL Standard Deviation 0.471	3.23 g/dL Standard Deviation 0.433
Change From Baseline in Biochemistry Parameter: Albumin Day 5	3.12 g/dL Standard Deviation 0.434	3.13 g/dL Standard Deviation 0.414
Change From Baseline in Biochemistry Parameter: Albumin Month 1	3.27 g/dL Standard Deviation 0.413	3.24 g/dL Standard Deviation 0.391
Change From Baseline in Biochemistry Parameter: Albumin Month 4	3.22 g/dL Standard Deviation 0.416	3.21 g/dL Standard Deviation 0.398

SECONDARY outcome

Timeframe: From baseline to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in Biochemistry Parameter: Alkaline Phosphatase Baseline	99.8 U/L Standard Deviation 46.71	101.8 U/L Standard Deviation 52.59
Change From Baseline in Biochemistry Parameter: Alkaline Phosphatase Day 5	91.9 U/L Standard Deviation 40.18	95.7 U/L Standard Deviation 46.43
Change From Baseline in Biochemistry Parameter: Alkaline Phosphatase Month 1	96.6 U/L Standard Deviation 47.88	98.3 U/L Standard Deviation 53.97
Change From Baseline in Biochemistry Parameter: Alkaline Phosphatase Month 4	98.6 U/L Standard Deviation 44.85	98.1 U/L Standard Deviation 49.90

SECONDARY outcome

Timeframe: From baseline to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in Biochemistry Parameter: Aspartate Aminotransferase Baseline	32.8 U/L Standard Deviation 10.20	32.7 U/L Standard Deviation 12.41
Change From Baseline in Biochemistry Parameter: Aspartate Aminotransferase Day 5	33.8 U/L Standard Deviation 11.21	37.2 U/L Standard Deviation 19.04
Change From Baseline in Biochemistry Parameter: Aspartate Aminotransferase Month 1	31.0 U/L Standard Deviation 9.50	32.6 U/L Standard Deviation 30.32
Change From Baseline in Biochemistry Parameter: Aspartate Aminotransferase Month 4	31.8 U/L Standard Deviation 10.95	31.1 U/L Standard Deviation 8.51

SECONDARY outcome

Timeframe: From baseline to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in Biochemistry Parameter: Calcium Baseline	2.314 mmol/L Standard Deviation 0.1341	2.322 mmol/L Standard Deviation 0.1216
Change From Baseline in Biochemistry Parameter: Calcium Day 5	2.279 mmol/L Standard Deviation 0.1681	2.328 mmol/L Standard Deviation 0.1550
Change From Baseline in Biochemistry Parameter: Calcium Month 1	2.305 mmol/L Standard Deviation 0.1499	2.298 mmol/L Standard Deviation 0.1904
Change From Baseline in Biochemistry Parameter: Calcium Month 4	2.297 mmol/L Standard Deviation 0.1399	2.297 mmol/L Standard Deviation 0.1514

SECONDARY outcome

Timeframe: From baseline to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in Biochemistry Parameter: Chloride Baseline	105.3 mmol/L Standard Deviation 3.05	105.3 mmol/L Standard Deviation 2.74
Change From Baseline in Biochemistry Parameter: Chloride Day 5	105.2 mmol/L Standard Deviation 3.22	105.2 mmol/L Standard Deviation 3.53
Change From Baseline in Biochemistry Parameter: Chloride Month 1	105.1 mmol/L Standard Deviation 3.04	105.0 mmol/L Standard Deviation 3.23
Change From Baseline in Biochemistry Parameter: Chloride Month 5	104.8 mmol/L Standard Deviation 2.89	104.8 mmol/L Standard Deviation 3.18

SECONDARY outcome

Timeframe: From baseline to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in Biochemistry Parameter: Creatinine Baseline	0.84 mg/dL Standard Deviation 0.238	0.84 mg/dL Standard Deviation 0.230
Change From Baseline in Biochemistry Parameter: Creatinine Day 5	0.83 mg/dL Standard Deviation 0.256	0.81 mg/dL Standard Deviation 0.233
Change From Baseline in Biochemistry Parameter: Creatinine Month 1	0.82 mg/dL Standard Deviation 0.230	0.81 mg/dL Standard Deviation 0.220
Change From Baseline in Biochemistry Parameter: Creatinine Month 4	0.81 mg/dL Standard Deviation 0.227	0.80 mg/dL Standard Deviation 0.223

SECONDARY outcome

Timeframe: From baseline to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in Biochemistry Parameter: Glucose Baseline	88.581 mg/dL Standard Deviation 19.9540	87.087 mg/dL Standard Deviation 11.3391
Change From Baseline in Biochemistry Parameter: Glucose Day 5	89.801 mg/dL Standard Deviation 14.4784	89.410 mg/dL Standard Deviation 9.9699
Change From Baseline in Biochemistry Parameter: Glucose Month 1	91.715 mg/dL Standard Deviation 16.4756	90.207 mg/dL Standard Deviation 10.8139
Change From Baseline in Biochemistry Parameter: Glucose Month 4	91.226 mg/dL Standard Deviation 24.4440	89.225 mg/dL Standard Deviation 10.2205

SECONDARY outcome

Timeframe: From baseline to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in Biochemistry Parameter: Potassium Baseline	4.58 mmol/L Standard Deviation 0.537	4.60 mmol/L Standard Deviation 0.572
Change From Baseline in Biochemistry Parameter: Potassium Day 5	4.67 mmol/L Standard Deviation 0.607	4.59 mmol/L Standard Deviation 0.559
Change From Baseline in Biochemistry Parameter: Potassium Month 1	4.61 mmol/L Standard Deviation 0.589	4.60 mmol/L Standard Deviation 0.636
Change From Baseline in Biochemistry Parameter: Potassium Month 4	4.59 mmol/L Standard Deviation 0.540	4.61 mmol/L Standard Deviation 0.550

SECONDARY outcome

Timeframe: From baseline to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in Biochemistry Parameter: Sodium Baseline	136.7 mmol/L Standard Deviation 3.39	136.7 mmol/L Standard Deviation 3.61
Change From Baseline in Biochemistry Parameter: Sodium Day 5	137.2 mmol/L Standard Deviation 3.75	137.1 mmol/L Standard Deviation 3.97
Change From Baseline in Biochemistry Parameter: Sodium Month 1	137.2 mmol/L Standard Deviation 3.41	137.1 mmol/L Standard Deviation 3.94
Change From Baseline in Biochemistry Parameter: Sodium Month 4	137.1 mmol/L Standard Deviation 3.36	137.0 mmol/L Standard Deviation 3.38

SECONDARY outcome

Timeframe: From baseline to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in Biochemistry Parameter: Total Bilirubin Baseline	0.879 mg/dL Standard Deviation 0.3457	0.869 mg/dL Standard Deviation 0.3469
Change From Baseline in Biochemistry Parameter: Total Bilirubin Day 5	0.739 mg/dL Standard Deviation 0.2957	0.809 mg/dL Standard Deviation 0.2506
Change From Baseline in Biochemistry Parameter: Total Bilirubin Month 1	0.818 mg/dL Standard Deviation 0.2641	0.884 mg/dL Standard Deviation 0.2591
Change From Baseline in Biochemistry Parameter: Total Bilirubin Month 4	0.887 mg/dL Standard Deviation 0.318	0.902 mg/dL Standard Deviation 0.2937

SECONDARY outcome

Timeframe: From baseline to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in Biochemistry Parameter: Bicarbonate Baseline	27.5 mmol/L Standard Deviation 2.46	27.5 mmol/L Standard Deviation 2.60
Change From Baseline in Biochemistry Parameter: Bicarbonate Day 5	28.5 mmol/L Standard Deviation 2.39	28.2 mmol/L Standard Deviation 2.40
Change From Baseline in Biochemistry Parameter: Bicarbonate Month 1	28.0 mmol/L Standard Deviation 2.50	27.7 mmol/L Standard Deviation 2.44
Change From Baseline in Biochemistry Parameter: Bicarbonate Month 4	28.0 mmol/L Standard Deviation 2.48	27.9 mmol/L Standard Deviation 2.58

SECONDARY outcome

Timeframe: From baseline to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in Biochemistry Parameter: Total Protein Baseline	7.63 g/dL Standard Deviation 0.589	7.65 g/dL Standard Deviation 0.565
Change From Baseline in Biochemistry Parameter: Total Protein Day 5	7.46 g/dL Standard Deviation 0.566	7.61 g/dL Standard Deviation 0.584
Change From Baseline in Biochemistry Parameter: Total Protein Month 1	7.55 g/dL Standard Deviation 0.547	7.59 g/dL Standard Deviation 0.583
Change From Baseline in Biochemistry Parameter: Total Protein Month 4	7.54 g/dL Standard Deviation 0.573	7.57 g/dL Standard Deviation 0.591

SECONDARY outcome

Timeframe: From baseline to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in Biochemistry Parameter: Blood Urea Nitrogen Baseline	7.434 mg/dL Standard Deviation 2.5471	7.415 mg/dL Standard Deviation 2.6550
Change From Baseline in Biochemistry Parameter: Blood Urea Nitrogen Day 5	8.402 mg/dL Standard Deviation 2.6432	8.358 mg/dL Standard Deviation 2.4459
Change From Baseline in Biochemistry Parameter: Blood Urea Nitrogen Month 1	6.951 mg/dL Standard Deviation 2.2998	6.820 mg/dL Standard Deviation 2.5365
Change From Baseline in Biochemistry Parameter: Blood Urea Nitrogen Month 4	7.501 mg/dL Standard Deviation 2.3841	7.383 mg/dL Standard Deviation 2.2759

SECONDARY outcome

Timeframe: From baseline to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in Hematology Parameter: Hemoglobin Month 4	13.04 g/dL Standard Deviation 1.644	12.93 g/dL Standard Deviation 1.646
Change From Baseline in Hematology Parameter: Hemoglobin Baseline	13.09 g/dL Standard Deviation 1.706	13.10 g/dL Standard Deviation 1.554
Change From Baseline in Hematology Parameter: Hemoglobin Day 5	12.57 g/dL Standard Deviation 1.627	12.95 g/dL Standard Deviation 1.513
Change From Baseline in Hematology Parameter: Hemoglobin Month 1	12.78 g/dL Standard Deviation 1.550	13.00 g/dL Standard Deviation 1.489

SECONDARY outcome

Timeframe: From baseline to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in Hematology Parameter: Platelet Count Baseline	229.1 10^9 platelets/L Standard Deviation 64.75	229.0 10^9 platelets/L Standard Deviation 63.04
Change From Baseline in Hematology Parameter: Platelet Count Day 5	230.5 10^9 platelets/L Standard Deviation 65.20	226.5 10^9 platelets/L Standard Deviation 65.84
Change From Baseline in Hematology Parameter: Platelet Count Month 1	227.7 10^9 platelets/L Standard Deviation 62.55	227.6 10^9 platelets/L Standard Deviation 64.01
Change From Baseline in Hematology Parameter: Platelet Count Month 4	228.4 10^9 platelets/L Standard Deviation 60.29	229.1 10^9 platelets/L Standard Deviation 63.44

SECONDARY outcome

Timeframe: From baseline to the Month 4 follow-up visit (End of Study).

Population: Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).

Changes from baseline to Day 5, Month 1 and Month 4; presented by treatment arm.

Outcome measures

Measure	Acoziborole n=906 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=300 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in Hematology Parameter: Leukocytes Day 5	5.64 10^9 Leukocytes/L Standard Deviation 1.563	5.60 10^9 Leukocytes/L Standard Deviation 1.507
Change From Baseline in Hematology Parameter: Leukocytes Baseline	5.53 10^9 Leukocytes/L Standard Deviation 1.576	5.46 10^9 Leukocytes/L Standard Deviation 1.539
Change From Baseline in Hematology Parameter: Leukocytes Month 1	5.51 10^9 Leukocytes/L Standard Deviation 1.446	5.50 10^9 Leukocytes/L Standard Deviation 1.427
Change From Baseline in Hematology Parameter: Leukocytes Month 4	5.49 10^9 Leukocytes/L Standard Deviation 1.385	5.52 10^9 Leukocytes/L Standard Deviation 1.426

SECONDARY outcome

Timeframe: From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)

Population: ECG central tendency set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data) and who had valid ECG evaluations.

Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an analysis of covariance (ANCOVA) model adjusted for sex and age.

Outcome measures

Measure	Acoziborole n=213 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=68 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in ECG (Electrocardiogram) Parameter: Heart Rate (HR) Day 1 (pre-dose)	66.8 beats/min Standard Deviation 10.7	70.0 beats/min Standard Deviation 12.1
Change From Baseline in ECG (Electrocardiogram) Parameter: Heart Rate (HR) Day 5	66.4 beats/min Standard Deviation 9.9	69.1 beats/min Standard Deviation 12.6
Change From Baseline in ECG (Electrocardiogram) Parameter: Heart Rate (HR) Change from baseline at Day 5 (Δ)	-0.4 beats/min Standard Deviation 8.4	-0.9 beats/min Standard Deviation 8.3

SECONDARY outcome

Timeframe: From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)

Population: ECG central tendency set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data) and who had valid ECG evaluations.

Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.

Outcome measures

Measure	Acoziborole n=213 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=68 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in ECG Parameter: RR Interval Day 1 (pre-dose)	921.6 ms Standard Deviation 143.8	882.2 ms Standard Deviation 149.3
Change From Baseline in ECG Parameter: RR Interval Day 5	923.5 ms Standard Deviation 137.4	893.7 ms Standard Deviation 149.4
Change From Baseline in ECG Parameter: RR Interval Change from baseline at Day 5 (Δ)	1.9 ms Standard Deviation 103.5	11.5 ms Standard Deviation 94.8

SECONDARY outcome

Timeframe: From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)

Population: ECG central tendency set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data) and who had valid ECG evaluations.

Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.

Outcome measures

Measure	Acoziborole n=213 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=68 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in ECG Parameter: PR Interval Day 1 (pre-dose)	162.4 ms Standard Deviation 25.2	162.2 ms Standard Deviation 20.3
Change From Baseline in ECG Parameter: PR Interval Day 5	161.4 ms Standard Deviation 23.0	161.9 ms Standard Deviation 20.5
Change From Baseline in ECG Parameter: PR Interval Change from baseline at Day 5 (Δ)	-1.0 ms Standard Deviation 1.11	-0.3 ms Standard Deviation 12.8

SECONDARY outcome

Timeframe: From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)

Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusting for sex and age.

Outcome measures

Measure	Acoziborole n=213 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=68 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in ECG Parameter: QRS Interval Day 1 (pre-dose)	82.2 ms Standard Deviation 8.2	82.3 ms Standard Deviation 10.2
Change From Baseline in ECG Parameter: QRS Interval Day 5	81.8 ms Standard Deviation 8.4	82.5 ms Standard Deviation 9.0
Change From Baseline in ECG Parameter: QRS Interval Change from baseline at Day 5 (Δ)	-0.5 ms Standard Deviation 5.4	0.3 ms Standard Deviation 4.5

SECONDARY outcome

Timeframe: From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)

Population: ECG central tendency set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data) and who had valid ECG evaluations.

Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.

Outcome measures

Measure	Acoziborole n=213 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=68 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in ECG Parameter: QT Interval Day 1 (pre-dose)	389.5 ms Standard Deviation 27.8	383.0 ms Standard Deviation 33.1
Change From Baseline in ECG Parameter: QT Interval Day 5	377.3 ms Standard Deviation 26.7	383.1 ms Standard Deviation 30.8
Change From Baseline in ECG Parameter: QT Interval Change from baseline at Day 5 (Δ)	-12.1 ms Standard Deviation 21.4	0.1 ms Standard Deviation 20.4

SECONDARY outcome

Timeframe: From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)

Population: ECG central tendency set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data) and who had valid ECG evaluations.

Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.

Outcome measures

Measure	Acoziborole n=213 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=68 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in ECG Parameter: QTcF Day 1 (pre-dose)	401.3 ms Standard Deviation 20.0	400.5 ms Standard Deviation 24.0
Change From Baseline in ECG Parameter: QTcF Day 5	388.5 ms Standard Deviation 20.5	399.0 ms Standard Deviation 21.8
Change From Baseline in ECG Parameter: QTcF Change from baseline at Day 5 (Δ)	-12.8 ms Standard Deviation 13.3	-1.5 ms Standard Deviation 13.8

SECONDARY outcome

Timeframe: From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)

Population: ECG central tendency set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data) and who had valid ECG evaluations.

Actual values at baseline (Day 1 pre-dose) and Day 5. Change from baseline at Day 5 (Δ). Placebo-corrected change from baseline (ΔΔ), calculated using an ANCOVA model adjusted for sex and age.

Outcome measures

Measure	Acoziborole n=213 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=68 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Change From Baseline in ECG Parameter: QTcB Day 1 (pre-dose)	407.9 ms Standard Deviation 23.0	410.1 ms Standard Deviation 25.8
Change From Baseline in ECG Parameter: QTcB Day 5	394.6 ms Standard Deviation 23.3	407.8 ms Standard Deviation 24.6
Change From Baseline in ECG Parameter: QTcB Change from baseline at Day 5 (Δ)	-13.3 ms Standard Deviation 14.2	-2.3 ms Standard Deviation 14.8

SECONDARY outcome

Timeframe: From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)

Population: C-R analysis set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data), who had valid ECG evaluations, and at least one change from baseline in ECG matching a PK sample.

Mixed linear model developed based on the model defined by Garnett et al (2017).

The fixed effect parameters of the pre-specified model were intercept, slope for acoziborole concentrations, influence of baseline (centered on mean), and a treatment specific intercept (0=acoziborole, 1=Placebo). Sex and age were included in the model as fixed covariates.

Outcome measures

Measure	Acoziborole n=192 Participants Acoziborole: 3 tablets of 320 mg	Placebo Acoziborole matching placebo: 3 tablets of 320 mg
Placebo-corrected Baseline-adjusted QTcF (ΔΔQTcF), Computed From a Concentration-response (C-R) Model Between Dry Blood Spot Concentration and Changes From Baseline in QTcF Parameter	-12.9 ms Interval -14.3 to -11.3	—

SECONDARY outcome

Timeframe: From baseline (Day 1 pre-dose) to Day 5 (End of Hospitalization)

Population: ECG categorical analyses set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data) and who had valid ECG evaluations at Day 1 or Day 5.

Incidence of abnormal values for PR, QRS, QTcB and QTcF at Day 1 and/or Day 5, according to pre-defined thresholds

Outcome measures

Measure	Acoziborole n=215 Participants Acoziborole: 3 tablets of 320 mg	Placebo n=68 Participants Acoziborole matching placebo: 3 tablets of 320 mg
Incidence of Abnormal Values for PR, QRS, QTcB and QTcF According to Pre-defined Thresholds HR <40 beats/min	0 Participants	0 Participants
Incidence of Abnormal Values for PR, QRS, QTcB and QTcF According to Pre-defined Thresholds HR >120 beats/min	0 Participants	0 Participants
Incidence of Abnormal Values for PR, QRS, QTcB and QTcF According to Pre-defined Thresholds HR relative change from baseline >25%	6 Participants	2 Participants
Incidence of Abnormal Values for PR, QRS, QTcB and QTcF According to Pre-defined Thresholds PR >220 ms	2 Participants	1 Participants
Incidence of Abnormal Values for PR, QRS, QTcB and QTcF According to Pre-defined Thresholds PR relative change from baseline >25%	0 Participants	0 Participants
Incidence of Abnormal Values for PR, QRS, QTcB and QTcF According to Pre-defined Thresholds QRS >120 ms	1 Participants	0 Participants
Incidence of Abnormal Values for PR, QRS, QTcB and QTcF According to Pre-defined Thresholds QRS relative change from baseline >25%	0 Participants	0 Participants
Incidence of Abnormal Values for PR, QRS, QTcB and QTcF According to Pre-defined Thresholds QTcF >450 ms and ≤480 ms	2 Participants	1 Participants
Incidence of Abnormal Values for PR, QRS, QTcB and QTcF According to Pre-defined Thresholds QTcF >480 ms and ≤500 ms	0 Participants	0 Participants
Incidence of Abnormal Values for PR, QRS, QTcB and QTcF According to Pre-defined Thresholds QTcF >500 ms	0 Participants	0 Participants
Incidence of Abnormal Values for PR, QRS, QTcB and QTcF According to Pre-defined Thresholds QTcF change from baseline >30 ms and ≤60 ms	0 Participants	0 Participants
Incidence of Abnormal Values for PR, QRS, QTcB and QTcF According to Pre-defined Thresholds QTcF change from >60 ms	0 Participants	0 Participants
Incidence of Abnormal Values for PR, QRS, QTcB and QTcF According to Pre-defined Thresholds QTcB >450 ms and ≤480 ms	3 Participants	1 Participants
Incidence of Abnormal Values for PR, QRS, QTcB and QTcF According to Pre-defined Thresholds QTcB >480 ms and ≤500 ms	1 Participants	0 Participants
Incidence of Abnormal Values for PR, QRS, QTcB and QTcF According to Pre-defined Thresholds QTcB >500 ms	0 Participants	0 Participants
Incidence of Abnormal Values for PR, QRS, QTcB and QTcF According to Pre-defined Thresholds QTcB change from baseline >30 ms and ≤60 ms	1 Participants	1 Participants
Incidence of Abnormal Values for PR, QRS, QTcB and QTcF According to Pre-defined Thresholds QTcB change from >60 ms	0 Participants	0 Participants

Adverse Events

Acoziborole

Serious events: 3 serious events

Other events: 137 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 45 other events

Deaths: 1 deaths

Serious adverse events

Measure	Acoziborole n=906 participants at risk Acoziborole: 3 tablets of 320 mg	Placebo n=300 participants at risk Acoziborole matching placebo: 3 tablets of 320 mg
Surgical and medical procedures Abortion induced	0.00% 0/906 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.	0.33% 1/300 • Number of events 1 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.
Infections and infestations Appendicitis	0.00% 0/906 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.	0.33% 1/300 • Number of events 1 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.
Infections and infestations Malaria	0.00% 0/906 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.	0.33% 1/300 • Number of events 1 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.
Infections and infestations Wound infection	0.00% 0/906 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.	0.33% 1/300 • Number of events 1 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.
Reproductive system and breast disorders Uterine prolapse	0.11% 1/906 • Number of events 1 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.	0.00% 0/300 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.
Reproductive system and breast disorders Vaginal haemorrhage	0.11% 1/906 • Number of events 1 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.	0.00% 0/300 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.
Pregnancy, puerperium and perinatal conditions Abortion	0.11% 1/906 • Number of events 1 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.	0.00% 0/300 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.

Other adverse events

Measure	Acoziborole n=906 participants at risk Acoziborole: 3 tablets of 320 mg	Placebo n=300 participants at risk Acoziborole matching placebo: 3 tablets of 320 mg
Nervous system disorders Headache	5.8% 53/906 • Number of events 54 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.	2.7% 8/300 • Number of events 9 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.
Infections and infestations Malaria	3.8% 34/906 • Number of events 35 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.	4.3% 13/300 • Number of events 13 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.
Gastrointestinal disorders Abdominal pain	2.5% 23/906 • Number of events 23 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.	3.0% 9/300 • Number of events 10 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.
General disorders Fatigue	1.5% 14/906 • Number of events 14 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.	1.7% 5/300 • Number of events 5 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.
Infections and infestations Acarodermatitis	1.4% 13/906 • Number of events 13 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.	1.0% 3/300 • Number of events 3 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.
Investigations Blood potassium increased	0.88% 8/906 • Number of events 8 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.	2.0% 6/300 • Number of events 7 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.
Gastrointestinal disorders Enteritis	0.77% 7/906 • Number of events 7 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.	1.3% 4/300 • Number of events 4 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.
Gastrointestinal disorders Nausea	0.77% 7/906 • Number of events 7 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.	1.0% 3/300 • Number of events 3 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.
Gastrointestinal disorders Gastritis	0.66% 6/906 • Number of events 6 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.	1.0% 3/300 • Number of events 3 • From ICF signature (up to 2 days prior treatment) to Month 4 (end of follow-up) The primary outcome of this study was the collection of Treatment Emergent Adverse Event (TEAE) (i.e collections of AE from Day 1 (post-treatment) to Month 4 (end of follow-up)) Of note, all AEs reported during this study were TEAEs.

Additional Information

Dr Junior Matanglia

Drugs for Neglected Disease initiative (DNDi)

Phone: +243 970 756 890

Email: jmatangila@dndi.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place