Trial Outcomes & Findings for A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH (NCT NCT02279524)
NCT ID: NCT02279524
Last Updated: 2021-07-14
Results Overview
absolute % change from baseline to end of study in liver triglycerides to water ratio (fat/water+fat) as measured by MRS
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
247 participants
Primary outcome timeframe
At screening (baseline) and at week 52
Results posted on
2021-07-14
Participant Flow
Participant milestones
| Measure |
Aramchol 600mg
One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg, once a day for 52 weeks
|
Aramchol 400mg
One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol, once a day for 52 weeks
|
Placebo
Two tablets of matching placebo for Aramchol, once a day for 52 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
98
|
101
|
48
|
|
Overall Study
COMPLETED
|
88
|
90
|
41
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
7
|
Reasons for withdrawal
| Measure |
Aramchol 600mg
One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg, once a day for 52 weeks
|
Aramchol 400mg
One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol, once a day for 52 weeks
|
Placebo
Two tablets of matching placebo for Aramchol, once a day for 52 weeks
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
3
|
|
Overall Study
Adverse Event
|
4
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
|
Overall Study
Disallowed medication
|
1
|
1
|
2
|
|
Overall Study
Bariatric surgery
|
1
|
0
|
0
|
Baseline Characteristics
A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH
Baseline characteristics by cohort
| Measure |
Aramchol 600mg
n=98 Participants
One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg.
|
Aramchol 400mg
n=101 Participants
One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol.
|
Placebo
n=48 Participants
Two tablet of Aramchol matching placebo.
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.9 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
53.9 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
54.4 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
160 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Latin
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Latin American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Latin Race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Mixed (Martinican)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
63 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
|
BMI (kg/m^2) at Screening
|
33 kg/m^2
STANDARD_DEVIATION 4.2 • n=5 Participants
|
32.4 kg/m^2
STANDARD_DEVIATION 4.5 • n=7 Participants
|
32.6 kg/m^2
STANDARD_DEVIATION 4.9 • n=5 Participants
|
32.7 kg/m^2
STANDARD_DEVIATION 4.4 • n=4 Participants
|
PRIMARY outcome
Timeframe: At screening (baseline) and at week 52Population: Pre-defined FASmri analysis set
absolute % change from baseline to end of study in liver triglycerides to water ratio (fat/water+fat) as measured by MRS
Outcome measures
| Measure |
Aramchol 600mg
n=83 Participants
One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg.
|
Aramchol 400mg
n=90 Participants
One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol.
|
Placebo
n=41 Participants
Two tablet of Aramchol matching placebo.
|
|---|---|---|---|
|
Change From Baseline in Mean Liver Fat
|
-3.18 Abs. % Change from Baseline Liver Fat
Standard Deviation 1.01
|
-3.41 Abs. % Change from Baseline Liver Fat
Standard Deviation 0.96
|
-0.09 Abs. % Change from Baseline Liver Fat
Standard Deviation 1.38
|
SECONDARY outcome
Timeframe: At screening and at week 52Population: FASBiopsy analysis set
The endpoint was defined as end of study biopsy, observed under microscope and showing: * Cell Ballooning (special form of liver cell injury associated with cell swelling and enlargement)= 0 * Inflammation (presence or absence of cells from the immune system) = 0 or 1 * No worsening of fibrosis (scar formation) = increase in fibrosis score by 1 or more point
Outcome measures
| Measure |
Aramchol 600mg
n=78 Participants
One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg.
|
Aramchol 400mg
n=80 Participants
One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol.
|
Placebo
n=40 Participants
Two tablet of Aramchol matching placebo.
|
|---|---|---|---|
|
NASH Resolution Without Worsening of Fibrosis
|
16.7 % of subjects reaching the end-point
|
7.5 % of subjects reaching the end-point
|
5 % of subjects reaching the end-point
|
SECONDARY outcome
Timeframe: At screening and at week 52Population: Predefined FASBiopsy analysis set
The endpoint was defined as end of study biopsy showing: * A decrease in fibrosis score ≥ 1 point * No worsening of NASH (defined by an increase of inflammation and/or ballooning)
Outcome measures
| Measure |
Aramchol 600mg
n=78 Participants
One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg.
|
Aramchol 400mg
n=80 Participants
One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol.
|
Placebo
n=40 Participants
Two tablet of Aramchol matching placebo.
|
|---|---|---|---|
|
Fibrosis Improvement Without Worsening of NASH
|
29.5 % of subjects reaching the end-point
|
21.3 % of subjects reaching the end-point
|
17.5 % of subjects reaching the end-point
|
SECONDARY outcome
Timeframe: At baseline until week 52Population: Pre-defined FASALT analysis set
Change from baseline to Week 52 or Termination visit in ALT levels (U/L)
Outcome measures
| Measure |
Aramchol 600mg
n=98 Participants
One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg.
|
Aramchol 400mg
n=100 Participants
One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol.
|
Placebo
n=47 Participants
Two tablet of Aramchol matching placebo.
|
|---|---|---|---|
|
Change From Baseline to Week 52/Termination in ALT
|
-17.3 U/L
Standard Error 3.7
|
-12.0 U/L
Standard Error 3.6
|
11.8 U/L
Standard Error 5.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baseline until week 52Population: Analysis Set: FASHgA1C
Change from baseline to Week 52 or Termination visit in Hemoglobin A1C (%)
Outcome measures
| Measure |
Aramchol 600mg
n=96 Participants
One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg.
|
Aramchol 400mg
n=98 Participants
One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol.
|
Placebo
n=47 Participants
Two tablet of Aramchol matching placebo.
|
|---|---|---|---|
|
Change From Baseline to Termination/Early Termination in HbA1C
|
-0.1268 % of HbA1C
Standard Error 0.0769
|
-0.0417 % of HbA1C
Standard Error 0.0754
|
0.3202 % of HbA1C
Standard Error 0.1089
|
POST_HOC outcome
Timeframe: At baseline until week 52Population: FASAST Analysis Set
Change from baseline to Week 52 or termination visit in AST levels (U/L)
Outcome measures
| Measure |
Aramchol 600mg
n=98 Participants
One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg.
|
Aramchol 400mg
n=100 Participants
One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol.
|
Placebo
n=47 Participants
Two tablet of Aramchol matching placebo.
|
|---|---|---|---|
|
Change From Baseline to Week 52/Termination in AST
|
-10.83 U/L
Standard Error 2.49
|
-7.21 U/L
Standard Error 2.42
|
6.68 U/L
Standard Error 3.50
|
POST_HOC outcome
Timeframe: Baseline to 52 weeksA responder is defined according to \>5% absolute improvement from baseline. A cutoff of 5% absolute reduction in liver F/(F+W) ratio was used as a surrogate for potentially clinically meaningful MRI reduction.
Outcome measures
| Measure |
Aramchol 600mg
n=83 Participants
One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg.
|
Aramchol 400mg
n=90 Participants
One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol.
|
Placebo
n=41 Participants
Two tablet of Aramchol matching placebo.
|
|---|---|---|---|
|
Change From Baseline in Mean Liver Fat - Responder Analysis
|
47.0 percentage of participants
|
36.7 percentage of participants
|
24.4 percentage of participants
|
POST_HOC outcome
Timeframe: Week 52Population: This analysis is limited by low number of events, and the duration of the study.
Fibrosis stage 4 in liver biopsy
Outcome measures
| Measure |
Aramchol 600mg
n=78 Participants
One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg.
|
Aramchol 400mg
n=80 Participants
One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol.
|
Placebo
n=40 Participants
Two tablet of Aramchol matching placebo.
|
|---|---|---|---|
|
Progression to Cirrhosis
|
1 Participants
|
6 Participants
|
3 Participants
|
Adverse Events
Aramchol 600mg
Serious events: 9 serious events
Other events: 77 other events
Deaths: 0 deaths
Aramchol 400mg
Serious events: 9 serious events
Other events: 75 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aramchol 600mg
n=98 participants at risk
One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg.
|
Aramchol 400mg
n=101 participants at risk
One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol.
|
Placebo
n=48 participants at risk
Two tablet of Aramchol matching placebo.
|
|---|---|---|---|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
2.1%
1/48 • 52 weeks + 13 weeks follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary emboli
|
0.00%
0/98 • 52 weeks + 13 weeks follow-up
|
0.99%
1/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/98 • 52 weeks + 13 weeks follow-up
|
0.99%
1/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Eye disorders
Retinal detachment
|
0.00%
0/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
2.1%
1/48 • 52 weeks + 13 weeks follow-up
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
1.0%
1/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/98 • 52 weeks + 13 weeks follow-up
|
0.99%
1/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
General disorders
Chest pain
|
1.0%
1/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
2.1%
1/48 • 52 weeks + 13 weeks follow-up
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/98 • 52 weeks + 13 weeks follow-up
|
0.99%
1/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Infections and infestations
Abscess limb
|
0.00%
0/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
2.1%
1/48 • 52 weeks + 13 weeks follow-up
|
|
Infections and infestations
Cellulitis
|
0.00%
0/98 • 52 weeks + 13 weeks follow-up
|
0.99%
1/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.0%
1/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.0%
1/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Investigations
Mammogram abnorma
|
0.00%
0/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
2.1%
1/48 • 52 weeks + 13 weeks follow-up
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/98 • 52 weeks + 13 weeks follow-up
|
0.99%
1/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.0%
1/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
2.1%
1/48 • 52 weeks + 13 weeks follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
2.1%
1/48 • 52 weeks + 13 weeks follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
2.1%
1/48 • 52 weeks + 13 weeks follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
1.0%
1/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.00%
0/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
2.1%
1/48 • 52 weeks + 13 weeks follow-up
|
|
Nervous system disorders
Lumbar radiculopathy .
|
1.0%
1/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Nervous system disorders
Radicular syndrome
|
1.0%
1/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Psychiatric disorders
Confusional state
|
1.0%
1/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Psychiatric disorders
Depression
|
1.0%
1/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/98 • 52 weeks + 13 weeks follow-up
|
0.99%
1/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Surgical and medical procedures
Shoulder operation
|
0.00%
0/98 • 52 weeks + 13 weeks follow-up
|
0.99%
1/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Nervous system disorders
Syncope
|
0.00%
0/98 • 52 weeks + 13 weeks follow-up
|
0.99%
1/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
Other adverse events
| Measure |
Aramchol 600mg
n=98 participants at risk
One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg.
|
Aramchol 400mg
n=101 participants at risk
One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol.
|
Placebo
n=48 participants at risk
Two tablet of Aramchol matching placebo.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
6.1%
6/98 • 52 weeks + 13 weeks follow-up
|
0.00%
0/101 • 52 weeks + 13 weeks follow-up
|
4.2%
2/48 • 52 weeks + 13 weeks follow-up
|
|
Gastrointestinal disorders
Abdominal pain
|
4.1%
4/98 • 52 weeks + 13 weeks follow-up
|
6.9%
7/101 • 52 weeks + 13 weeks follow-up
|
4.2%
2/48 • 52 weeks + 13 weeks follow-up
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.1%
6/98 • 52 weeks + 13 weeks follow-up
|
4.0%
4/101 • 52 weeks + 13 weeks follow-up
|
4.2%
2/48 • 52 weeks + 13 weeks follow-up
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.1%
4/98 • 52 weeks + 13 weeks follow-up
|
6.9%
7/101 • 52 weeks + 13 weeks follow-up
|
2.1%
1/48 • 52 weeks + 13 weeks follow-up
|
|
General disorders
Asthenia
|
5.1%
5/98 • 52 weeks + 13 weeks follow-up
|
4.0%
4/101 • 52 weeks + 13 weeks follow-up
|
2.1%
1/48 • 52 weeks + 13 weeks follow-up
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.1%
5/98 • 52 weeks + 13 weeks follow-up
|
5.9%
6/101 • 52 weeks + 13 weeks follow-up
|
2.1%
1/48 • 52 weeks + 13 weeks follow-up
|
|
Infections and infestations
Bronchitis
|
6.1%
6/98 • 52 weeks + 13 weeks follow-up
|
5.0%
5/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Gastrointestinal disorders
Constipation
|
8.2%
8/98 • 52 weeks + 13 weeks follow-up
|
5.0%
5/101 • 52 weeks + 13 weeks follow-up
|
12.5%
6/48 • 52 weeks + 13 weeks follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
5/98 • 52 weeks + 13 weeks follow-up
|
4.0%
4/101 • 52 weeks + 13 weeks follow-up
|
8.3%
4/48 • 52 weeks + 13 weeks follow-up
|
|
Gastrointestinal disorders
Diarrhea
|
6.1%
6/98 • 52 weeks + 13 weeks follow-up
|
4.0%
4/101 • 52 weeks + 13 weeks follow-up
|
6.2%
3/48 • 52 weeks + 13 weeks follow-up
|
|
Gastrointestinal disorders
Dyspepsia
|
5.1%
5/98 • 52 weeks + 13 weeks follow-up
|
3.0%
3/101 • 52 weeks + 13 weeks follow-up
|
2.1%
1/48 • 52 weeks + 13 weeks follow-up
|
|
General disorders
Fatigue
|
3.1%
3/98 • 52 weeks + 13 weeks follow-up
|
7.9%
8/101 • 52 weeks + 13 weeks follow-up
|
8.3%
4/48 • 52 weeks + 13 weeks follow-up
|
|
Nervous system disorders
Headache
|
15.3%
15/98 • 52 weeks + 13 weeks follow-up
|
13.9%
14/101 • 52 weeks + 13 weeks follow-up
|
12.5%
6/48 • 52 weeks + 13 weeks follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
5.1%
5/98 • 52 weeks + 13 weeks follow-up
|
7.9%
8/101 • 52 weeks + 13 weeks follow-up
|
4.2%
2/48 • 52 weeks + 13 weeks follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
6.1%
6/98 • 52 weeks + 13 weeks follow-up
|
5.0%
5/101 • 52 weeks + 13 weeks follow-up
|
0.00%
0/48 • 52 weeks + 13 weeks follow-up
|
|
Gastrointestinal disorders
Nausea
|
9.2%
9/98 • 52 weeks + 13 weeks follow-up
|
9.9%
10/101 • 52 weeks + 13 weeks follow-up
|
12.5%
6/48 • 52 weeks + 13 weeks follow-up
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.2%
10/98 • 52 weeks + 13 weeks follow-up
|
6.9%
7/101 • 52 weeks + 13 weeks follow-up
|
4.2%
2/48 • 52 weeks + 13 weeks follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
4.1%
4/98 • 52 weeks + 13 weeks follow-up
|
5.0%
5/101 • 52 weeks + 13 weeks follow-up
|
6.2%
3/48 • 52 weeks + 13 weeks follow-up
|
|
Renal and urinary disorders
Urinary tract infection
|
13.3%
13/98 • 52 weeks + 13 weeks follow-up
|
14.9%
15/101 • 52 weeks + 13 weeks follow-up
|
6.2%
3/48 • 52 weeks + 13 weeks follow-up
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
3/98 • 52 weeks + 13 weeks follow-up
|
3.0%
3/101 • 52 weeks + 13 weeks follow-up
|
6.2%
3/48 • 52 weeks + 13 weeks follow-up
|
Additional Information
Medical Director
Galmed Research and Development, Ltd.
Phone: +972.3.693.8448
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Consistent with scientific standards, publication of the results of the study shall be made only as part of a publication of the results obtained by all sites performing the protocol. Investigators who wish to publish the results, must provide Galmed with a manuscript for review 60 (sixty) days prior to submission for publication. Galmed retains the right to delete confidential and proprietary information and to object suggested publication and/or its timing (at the Company's sole discretion).
- Publication restrictions are in place
Restriction type: OTHER