Trial · NCT05256017

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

NCT05256017, Phase 2, Phase 3, Completed, Drugs for Neglected Diseases; results first posted 2025-03-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Tolerability Study of Acoziborole in g-HAT Seropositive Subjects. Trials, record NCT05256017. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05256017

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Tolerability Study of Acoziborole in g-HAT Seropositive Subjects
NCT number: NCT05256017
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 1,208 participants, actual
Lead sponsor: Drugs for Neglected Diseases
Conditions: Trypanosomiasis, African, Trypanosoma Brucei Gambiense; Infection, Sleeping Sickness
Interventions: Acoziborole, Placebo
First posted: 2022-02-25
Last updated: 2025-03-20
Results first posted: 2025-03-20
Limitations and caveats: No limitations or caveats were identified.

Source ClinicalTrials.gov

Registered outcomes42

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Occurrence of Any TEAEs	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Occurrence and excess rate (95% CI) of any TEAEs.
Primary	Occurrence of TEAEs - Malaria	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
Primary	Occurrence of TEAEs - Acarodermatitis	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
Primary	Occurrence of TEAEs - Abdominal Pain	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
Primary	Occurrence of TEAEs - Enteritis	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
Primary	Occurrence of TEAEs - Nausea	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
Primary	Occurrence of TEAEs - Gastritis	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
Primary	Occurrence of TEAEs - Headache	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
Primary	Occurrence of TEAEs - Fatigue	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).
Primary	Occurrence of TEAEs - Blood Potassium Increased	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Occurrence and excess rate (95% CI) of common TEAEs (by PT, for PTs reported in ≥1% of participants in either arm).

1 to 10 of 42Source ClinicalTrials.gov

See all 42 registered outcomes

Outcomes42

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Occurrence of Any TEAEs	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Occurrence of TEAEs - Malaria	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Occurrence of TEAEs - Acarodermatitis	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Occurrence of TEAEs - Abdominal Pain	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Occurrence of TEAEs - Enteritis	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Occurrence of TEAEs - Nausea	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Occurrence of TEAEs - Gastritis	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Occurrence of TEAEs - Headache	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Occurrence of TEAEs - Fatigue	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Occurrence of TEAEs - Blood Potassium Increased	From the investigational product administration (Day 1) to the Month 4 follow-up visit (End of Study).	Safety set: participants who received at least 1 tablet of the investigational product (based on the actual treatment received, confirmed by drug concentration data).	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 42Source ClinicalTrials.gov

See all 42 outcomes

Results by group283

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Occurrence of Any TEAEs	Acoziborole	195	Participants
Occurrence of Any TEAEs	Placebo	69	Participants
Occurrence of TEAEs - Malaria	Acoziborole	34	Participants
Occurrence of TEAEs - Malaria	Placebo	14	Participants
Occurrence of TEAEs - Acarodermatitis	Acoziborole	13	Participants
Occurrence of TEAEs - Acarodermatitis	Placebo	3	Participants
Occurrence of TEAEs - Abdominal Pain	Acoziborole	23	Participants
Occurrence of TEAEs - Abdominal Pain	Placebo	9	Participants
Occurrence of TEAEs - Enteritis	Acoziborole	7	Participants
Occurrence of TEAEs - Enteritis	Placebo	4	Participants

1 to 10 of 283Source ClinicalTrials.gov

See all 283 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period	STARTED	Acoziborole	907
Treatment Period	STARTED	Placebo	301
Treatment Period	COMPLETED	Acoziborole	906
Treatment Period	COMPLETED	Placebo	300
Treatment Period	NOT COMPLETED	Acoziborole	1
Treatment Period	NOT COMPLETED	Placebo	1
Follow-up	STARTED	Acoziborole	906
Follow-up	STARTED	Placebo	300
Follow-up	COMPLETED	Acoziborole	898
Follow-up	COMPLETED	Placebo	298

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events32

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Acoziborole	53	906	54
other	Headache	Nervous system disorders	Placebo	8	300	9
other	Malaria	Infections and infestations	Acoziborole	34	906	35
other	Malaria	Infections and infestations	Placebo	13	300	13
other	Abdominal pain	Gastrointestinal disorders	Acoziborole	23	906	23
other	Abdominal pain	Gastrointestinal disorders	Placebo	9	300	10
other	Fatigue	General disorders	Acoziborole	14	906	14
other	Fatigue	General disorders	Placebo	5	300	5
other	Acarodermatitis	Infections and infestations	Acoziborole	13	906	13
other	Acarodermatitis	Infections and infestations	Placebo	3	300	3

1 to 10 of 32Source ClinicalTrials.gov

See all 32 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Acoziborole	0	906
Total, all-cause mortality	Placebo	1	300
Total, other adverse events	Acoziborole	137	906
Total, other adverse events	Placebo	45	300
Total, serious adverse events	Acoziborole	3	906
Total, serious adverse events	Placebo	4	300

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons16

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Acoziborole vs Placebo: Occurrence of TEAEs - Headache	Trial comparisons
Acoziborole vs Placebo: Occurrence of Serious TEAEs	Trial comparisons
Acoziborole vs Placebo: Occurrence of TEAEs - Gastritis	Trial comparisons
Acoziborole vs Placebo: Occurrence of Severe Treatment-related TEAEs	Trial comparisons
Acoziborole vs Placebo: Occurrence of TEAEs - Fatigue	Trial comparisons
Acoziborole vs Placebo: Occurrence of Adverse Events (AEs)	Trial comparisons
Acoziborole vs Placebo: Occurrence of Any Treatment-related TEAEs	Trial comparisons
Acoziborole vs Placebo: Occurrence of TEAEs - Acarodermatitis	Trial comparisons
Acoziborole vs Placebo: Occurrence of TEAEs - Nausea	Trial comparisons
Acoziborole vs Placebo: Occurrence of TEAEs - Malaria	Trial comparisons

1 to 10 of 16

See all 16 trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05256017

GET https://conductscience.org/api/trials/v1/NCT05256017/registered?page=2

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