Trial Outcomes & Findings for Study of the Safety and Tolerability of AXA1957 in Adolescent Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD) (NCT NCT04073407)
NCT ID: NCT04073407
Last Updated: 2021-09-23
Results Overview
Study food product emergent adverse events (AEs). Subjects reporting \>or equal to 1 study food product-emergent AE.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
AEs Baseline to week 13 - Part 1
Results posted on
2021-09-23
Participant Flow
Participant milestones
| Measure |
AXA1957
AXA1957 20.4g
AXA1957: Amino acids, food study
|
Placebo
Placebo 24g
Placebo: placebo
|
|---|---|---|
|
Part 1
STARTED
|
6
|
3
|
|
Part 1
COMPLETED
|
1
|
2
|
|
Part 1
NOT COMPLETED
|
5
|
1
|
|
Part 2
STARTED
|
0
|
1
|
|
Part 2
COMPLETED
|
0
|
0
|
|
Part 2
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
AXA1957
AXA1957 20.4g
AXA1957: Amino acids, food study
|
Placebo
Placebo 24g
Placebo: placebo
|
|---|---|---|
|
Part 1
Withdrawal by Subject
|
1
|
0
|
|
Part 1
Subjects discontinued in response to restrictions on the study due to impact of COVID-19 pandemic
|
4
|
1
|
|
Part 2
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Study of the Safety and Tolerability of AXA1957 in Adolescent Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
Baseline characteristics by cohort
| Measure |
AXA1957
n=6 Participants
AXA1957 20.4g
AXA1957: Amino acids, food study
|
Placebo
n=3 Participants
Placebo 24g
Placebo: placebo
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
13.5 years
STANDARD_DEVIATION 1.38 • n=99 Participants
|
13.7 years
STANDARD_DEVIATION 1.15 • n=107 Participants
|
13.6 years
STANDARD_DEVIATION 1.24 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: AEs Baseline to week 13 - Part 1Population: Safety analysis for Part 1 Baseline to week 13
Study food product emergent adverse events (AEs). Subjects reporting \>or equal to 1 study food product-emergent AE.
Outcome measures
| Measure |
AXA1957
n=6 Participants
AXA1957 20.4g
AXA1957: Amino acids, food study
|
Placebo
n=3 Participants
Placebo 24g
Placebo: placebo
|
|---|---|---|
|
Number of Subjects With Adverse Events (AEs).
|
2 Participants
|
1 Participants
|
Adverse Events
AXA1957
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AXA1957
n=6 participants at risk
AXA1957 20.4g
AXA1957: Amino acids, food study
|
Placebo
n=3 participants at risk
Placebo 24g
Placebo: placebo
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • From the time of informed consent up to first administration of study product on Day 1, any untoward medical occurrence considered related to study procedures will be recorded as an AE. Adverse events that occur from the first administration of study product on Day 1 through Week 13 (Part 1) and through Week 27 / Follow-up (Part 2 / Optional) will be considered treatment-emergent AEs.
|
0.00%
0/3 • From the time of informed consent up to first administration of study product on Day 1, any untoward medical occurrence considered related to study procedures will be recorded as an AE. Adverse events that occur from the first administration of study product on Day 1 through Week 13 (Part 1) and through Week 27 / Follow-up (Part 2 / Optional) will be considered treatment-emergent AEs.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • From the time of informed consent up to first administration of study product on Day 1, any untoward medical occurrence considered related to study procedures will be recorded as an AE. Adverse events that occur from the first administration of study product on Day 1 through Week 13 (Part 1) and through Week 27 / Follow-up (Part 2 / Optional) will be considered treatment-emergent AEs.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent up to first administration of study product on Day 1, any untoward medical occurrence considered related to study procedures will be recorded as an AE. Adverse events that occur from the first administration of study product on Day 1 through Week 13 (Part 1) and through Week 27 / Follow-up (Part 2 / Optional) will be considered treatment-emergent AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From the time of informed consent up to first administration of study product on Day 1, any untoward medical occurrence considered related to study procedures will be recorded as an AE. Adverse events that occur from the first administration of study product on Day 1 through Week 13 (Part 1) and through Week 27 / Follow-up (Part 2 / Optional) will be considered treatment-emergent AEs.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent up to first administration of study product on Day 1, any untoward medical occurrence considered related to study procedures will be recorded as an AE. Adverse events that occur from the first administration of study product on Day 1 through Week 13 (Part 1) and through Week 27 / Follow-up (Part 2 / Optional) will be considered treatment-emergent AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From the time of informed consent up to first administration of study product on Day 1, any untoward medical occurrence considered related to study procedures will be recorded as an AE. Adverse events that occur from the first administration of study product on Day 1 through Week 13 (Part 1) and through Week 27 / Follow-up (Part 2 / Optional) will be considered treatment-emergent AEs.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent up to first administration of study product on Day 1, any untoward medical occurrence considered related to study procedures will be recorded as an AE. Adverse events that occur from the first administration of study product on Day 1 through Week 13 (Part 1) and through Week 27 / Follow-up (Part 2 / Optional) will be considered treatment-emergent AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • From the time of informed consent up to first administration of study product on Day 1, any untoward medical occurrence considered related to study procedures will be recorded as an AE. Adverse events that occur from the first administration of study product on Day 1 through Week 13 (Part 1) and through Week 27 / Follow-up (Part 2 / Optional) will be considered treatment-emergent AEs.
|
0.00%
0/3 • From the time of informed consent up to first administration of study product on Day 1, any untoward medical occurrence considered related to study procedures will be recorded as an AE. Adverse events that occur from the first administration of study product on Day 1 through Week 13 (Part 1) and through Week 27 / Follow-up (Part 2 / Optional) will be considered treatment-emergent AEs.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • From the time of informed consent up to first administration of study product on Day 1, any untoward medical occurrence considered related to study procedures will be recorded as an AE. Adverse events that occur from the first administration of study product on Day 1 through Week 13 (Part 1) and through Week 27 / Follow-up (Part 2 / Optional) will be considered treatment-emergent AEs.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent up to first administration of study product on Day 1, any untoward medical occurrence considered related to study procedures will be recorded as an AE. Adverse events that occur from the first administration of study product on Day 1 through Week 13 (Part 1) and through Week 27 / Follow-up (Part 2 / Optional) will be considered treatment-emergent AEs.
|
|
Nervous system disorders
Migraine
|
0.00%
0/6 • From the time of informed consent up to first administration of study product on Day 1, any untoward medical occurrence considered related to study procedures will be recorded as an AE. Adverse events that occur from the first administration of study product on Day 1 through Week 13 (Part 1) and through Week 27 / Follow-up (Part 2 / Optional) will be considered treatment-emergent AEs.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent up to first administration of study product on Day 1, any untoward medical occurrence considered related to study procedures will be recorded as an AE. Adverse events that occur from the first administration of study product on Day 1 through Week 13 (Part 1) and through Week 27 / Follow-up (Part 2 / Optional) will be considered treatment-emergent AEs.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From the time of informed consent up to first administration of study product on Day 1, any untoward medical occurrence considered related to study procedures will be recorded as an AE. Adverse events that occur from the first administration of study product on Day 1 through Week 13 (Part 1) and through Week 27 / Follow-up (Part 2 / Optional) will be considered treatment-emergent AEs.
|
33.3%
1/3 • Number of events 1 • From the time of informed consent up to first administration of study product on Day 1, any untoward medical occurrence considered related to study procedures will be recorded as an AE. Adverse events that occur from the first administration of study product on Day 1 through Week 13 (Part 1) and through Week 27 / Follow-up (Part 2 / Optional) will be considered treatment-emergent AEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place