Trial Outcomes & Findings for A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR) (NCT NCT04104321)
NCT ID: NCT04104321
Last Updated: 2024-12-16
Results Overview
Improvement of fibrosis was defined by the following: 1. One stage or more reduction in fibrosis stage as assesed by the NASH-CRN classification 2. Ranked paired assessment between post-baseline compared to baseline biopsies (i,proved, worsened or stable fibrosis) 3. Reduction in the the continous phenotypic Fibrosis composite severity (Ph-FCS) score ≥0.3 in absolute value or ≥25% in relative value
Recruitment status
SUSPENDED
Study phase
PHASE3
Target enrollment
157 participants
Primary outcome timeframe
Up to 72 or 120 weeks
Results posted on
2024-12-16
Participant Flow
Participant milestones
| Measure |
ARCON ITT
All subjects who were randomized to Aramchol
|
|---|---|
|
Overall Study
STARTED
|
157
|
|
Overall Study
Subjects Randomized to the OL Part, Received Aramchol and Had Baseline and Post-baseline Biopsy
|
51
|
|
Overall Study
COMPLETED
|
154
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
ARCON ITT
All subjects who were randomized to Aramchol
|
|---|---|
|
Overall Study
didn't take the study drug
|
3
|
Baseline Characteristics
Data for 3 patients was missing
Baseline characteristics by cohort
| Measure |
ARCON ITT
n=157 Participants
All subjects who were randomized to Aramchol
|
|---|---|
|
Age, Continuous
|
58.1 Years
STANDARD_DEVIATION 10.2 • n=157 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
127 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
134 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
84 participants
n=157 Participants
|
|
Region of Enrollment
Turkey
|
25 participants
n=157 Participants
|
|
Region of Enrollment
South Korea
|
10 participants
n=157 Participants
|
|
Region of Enrollment
Mexico
|
7 participants
n=157 Participants
|
|
Region of Enrollment
Chile
|
6 participants
n=157 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=157 Participants
|
|
Region of Enrollment
France
|
5 participants
n=157 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=157 Participants
|
|
Region of Enrollment
Australia
|
4 participants
n=157 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=157 Participants
|
|
Region of Enrollment
Israel
|
2 participants
n=157 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=157 Participants
|
|
Weight (kg)
|
89 Kg
STANDARD_DEVIATION 15.2 • n=154 Participants • Data for 3 patients was missing
|
|
Body mass index (kg/m2)
|
32.7 Kg/ M2
STANDARD_DEVIATION 4.2 • n=136 Participants • Height data was missing for 21 patients
|
|
Biopsy evaluation based on NASH CRN
Baseline CRN fibrosis stage- F1
|
33 Participants
n=157 Participants
|
|
Biopsy evaluation based on NASH CRN
Baseline CRN fibrosis stage- F2
|
34 Participants
n=157 Participants
|
|
Biopsy evaluation based on NASH CRN
Baseline CRN fibrosis stage- F3
|
76 Participants
n=157 Participants
|
|
Biopsy evaluation based on NASH CRN
Baseline CRN fibrosis stage- F4
|
8 Participants
n=157 Participants
|
|
Biopsy evaluation based on NASH CRN
Not reported
|
6 Participants
n=157 Participants
|
|
NAS score
|
5.0 units on a scale
STANDARD_DEVIATION 1.2 • n=157 Participants
|
PRIMARY outcome
Timeframe: Up to 72 or 120 weeksPopulation: 51 subjects performed a Baseline and post-baseline biopsy
Improvement of fibrosis was defined by the following: 1. One stage or more reduction in fibrosis stage as assesed by the NASH-CRN classification 2. Ranked paired assessment between post-baseline compared to baseline biopsies (i,proved, worsened or stable fibrosis) 3. Reduction in the the continous phenotypic Fibrosis composite severity (Ph-FCS) score ≥0.3 in absolute value or ≥25% in relative value
Outcome measures
| Measure |
Aramchol
n=51 Participants
Aramchol 300 mg oral tablet
Aramchol: Aramchol 300 mg BID
|
|---|---|
|
Open Label Part: Improvement of Fibrosis Based on Liver Biopsy
Fibrosis improvement NASH-CRN≥1 stage
|
31.4 percentage of participants improving
Interval 19.1 to 45.9
|
|
Open Label Part: Improvement of Fibrosis Based on Liver Biopsy
NASH resolution without worsening of fibrosis
|
26.5 percentage of participants improving
Interval 14.9 to 37.5
|
|
Open Label Part: Improvement of Fibrosis Based on Liver Biopsy
Fibrosis improvement by ranked assessment
|
51.0 percentage of participants improving
Interval 36.6 to 65.2
|
|
Open Label Part: Improvement of Fibrosis Based on Liver Biopsy
Fibrosis improvement (absolute FCS score reduction ≥0.3
|
74.5 percentage of participants improving
Interval 60.4 to 85.7
|
|
Open Label Part: Improvement of Fibrosis Based on Liver Biopsy
Fibrosis improvement (relative FCS reduction by ≥25% AI cutoff)
|
41.2 percentage of participants improving
Interval 27.6 to 55.8
|
PRIMARY outcome
Timeframe: 72 weeks* Resolution of NASH defined as the Proportion (%) of subjects with resolution of NASH (defined by Ballooning of 0 and inflammation 0-1) and no worsening of liver fibrosis, or * Improvement in Fibrosis defined as the Proportion (%) of subjects with improvement in liver fibrosis greater than or equal to one stage and no worsening of steatohepatitis.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: at End of Study, latest at 5 years from last subject's randomizationProportion (%) of subjects experiencing at least 1 of the following events: All-cause mortality, Liver transplant, Histological progression to cirrhosis, MELD score \>15, Hospitalization due to hepatic decompensation event(s).
Outcome measures
Outcome data not reported
Adverse Events
Patients Randomized to the OL Part of the ARMOR Study
Serious events: 1 serious events
Other events: 27 other events
Deaths: 154 deaths
Serious adverse events
| Measure |
Patients Randomized to the OL Part of the ARMOR Study
n=154 participants at risk
Patients that have been randomized to the OL part of the ARMOR study and receiving Aramchol 300 mg BID
|
|---|---|
|
Cardiac disorders
coronary artery disease
|
0.65%
1/154 • Number of events 1 • Up to 124 weeks
|
|
Cardiac disorders
Coronary artery stenosis
|
0.65%
1/154 • Number of events 1 • Up to 124 weeks
|
|
Eye disorders
Retinal detachment
|
0.65%
1/154 • Number of events 1 • Up to 124 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.65%
1/154 • Number of events 1 • Up to 124 weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.65%
1/154 • Number of events 1 • Up to 124 weeks
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.65%
1/154 • Number of events 1 • Up to 124 weeks
|
|
Infections and infestations
COVID-19
|
0.65%
1/154 • Number of events 1 • Up to 124 weeks
|
|
Infections and infestations
COVID-19 pneumonia
|
0.65%
1/154 • Number of events 1 • Up to 124 weeks
|
|
Infections and infestations
Pneumonia
|
0.65%
1/154 • Number of events 1 • Up to 124 weeks
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.65%
1/154 • Number of events 1 • Up to 124 weeks
|
|
Injury, poisoning and procedural complications
Post-procedural complication
|
0.65%
1/154 • Number of events 1 • Up to 124 weeks
|
|
Injury, poisoning and procedural complications
Post-procedural haemorrhage
|
0.65%
1/154 • Number of events 1 • Up to 124 weeks
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.65%
1/154 • Number of events 1 • Up to 124 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.65%
1/154 • Number of events 1 • Up to 124 weeks
|
|
Nervous system disorders
Dizziness
|
0.65%
1/154 • Number of events 1 • Up to 124 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.65%
1/154 • Number of events 1 • Up to 124 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.65%
1/154 • Number of events 1 • Up to 124 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.65%
1/154 • Number of events 1 • Up to 124 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.65%
1/154 • Number of events 1 • Up to 124 weeks
|
Other adverse events
| Measure |
Patients Randomized to the OL Part of the ARMOR Study
n=154 participants at risk
Patients that have been randomized to the OL part of the ARMOR study and receiving Aramchol 300 mg BID
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
9/154 • Number of events 10 • Up to 124 weeks
|
|
Infections and infestations
COVID-19
|
17.5%
27/154 • Number of events 29 • Up to 124 weeks
|
|
Gastrointestinal disorders
Constipation
|
5.2%
8/154 • Number of events 10 • Up to 124 weeks
|
|
Nervous system disorders
Headache
|
7.8%
12/154 • Number of events 18 • Up to 124 weeks
|
|
Cardiac disorders
Hypertension
|
6.5%
10/154 • Number of events 10 • Up to 124 weeks
|
|
Gastrointestinal disorders
Nausea
|
5.2%
8/154 • Number of events 8 • Up to 124 weeks
|
|
Surgical and medical procedures
Procedural pain
|
5.2%
8/154 • Number of events 9 • Up to 124 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place