Non Alcoholic Steatohepatitis (NASH)
Conditions
Brief summary
A Phase 2b study to evaluate the efficacy of different doses of NST-4016 on the resolution of NASH without worsening of fibrosis
Detailed description
This is a 62 week (including screening and follow-up), multicenter, randomized, double blind, placebo-controlled, parallel group study in male and female patients with a histological diagnosis of NASH. The study includes a screening period, double blind treatment period, and post-treatment follow up
Interventions
DRUGIcosabutate
Icosabutate oral capsule once daily
DRUGPlacebo
Matching placebo oral capsule
Sponsors
NorthSea Therapeutics B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Provides signed written informed consent and agrees to comply with the study protocol. * Is a male or female aged 18 to 75 years, inclusive. * Has a histological diagnosis of NASH prior to study entry * Has (NAS) greater than or equal to 4, with a score of at least 1 in each component (steatosis, lobular inflammation, and ballooning), * Has a fibrosis score F1 to F3, inclusive (F1 capped at 30%), * Has a Proton Density Fat Fraction (PDFF) greater than or equal to 10% on MRI at screening
Exclusion criteria
* Has a known history of alcohol abuse or daily heavy alcohol consumption * Has had bariatric surgery within the past 5 years * Has significant systemic or major illnesses other than liver disease * Has a recent (within 6 months) history of cardiac dysrhythmias and/or cardiovascular disease * Has uncontrolled arterial hypertension * Positive for Hep B, Hepatitis C Virus (HCV) or HCV Polymerase Chain Reaction (PCR) * Has type 1 diabetes mellitus * Has diabetic ketoacidosis * Has a history of liver decompensation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Patients With Resolution of NASH, Defined as Disappearance of Ballooning (Score = 0) With Lobular Inflammation Score 0 or 1, With no Worsening of Fibrosis. | 52 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement. | 52 weeks | — |
| Changes in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline | 52 weeks | — |
| Change in Bilirubin Micromol/L From Baseline | 52 weeks | — |
| Change From Baseline in Inflammation Marker hsCRP | 52 weeks | — |
| Change From Baseline in Fibrosis Activity Marker Pro-C3 | 52 weeks | — |
| Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement and no Worsening of Steatohepatitis (Inflammation/Ballooning). | 52 weeks | — |
| Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 52 weeks | HOMA-IR is a measure of insulin resistance and metabolic status. The higher the score, the higher the level of insulin resistance. HOMA-IR = fasting glucose \[mmol/L)\] × fasting insulin \[mIU/L\]/22.5. As HOMA-IR is a composite score using 2 parameters, it does not have a finite range. |
| Change From Baseline in Composite Disease Activity Score (Composite NASH Score of Inflammation, Ballooning, Fibrosis) | 52 weeks | The disease activity score can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2). The higher the score the more severe the disease. |
| Change From Baseline in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) | 52 weeks | A histological scoring system that assesses a liver biopsy and gives scores for steatosis (0-3), lobular inflammation (0-3), and hepatocyte ballooning (0-2) giving a total score of (0-8). The higher the score the more severe the disease |
| Changes in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline | 52 weeks | Changes in scores for the individual component parts of the Nonalcoholic fatty liver disease (NAFLD) activity score (NAS) as judged by a pathologist examining sections from a liver biopsy; steatosis (range 0-3), lobular inflammation (range 0-3), and hepatocyte ballooning (range 0-2) In all cases a higher number denotes more severe disease activity |
| Change From Baseline in Magnetic Resonance Imaging-Proton Density-Fat Fraction (MRI-PDFF) | 52 weeks | MRI-PDFF is a quantitative imaging biomarker that measures the fat fraction of tissue by correcting factors influencing magnetic resonance signal intensity. |
| Change From Baseline in Fibrosis Activity Marker Enhanced Liver Fibrosis (ELF) Test | 52 weeks | ELF is a blood test that measures liver fibrosis by analyzing three markers in the blood: Hyaluronic acid (HA), Procollagen III amino-terminal peptide (PIIINP), and Tissue inhibitor of matrix metalloproteinase 1 (TIMP-1). The higher the score the higher the levels of markers in the blood. ELF score = 2.278 + 0.851 × ln(HA) + 0.751 × ln(PIIINP) + 0.394 × ln(TIMP-1). As the score is a composite measure of the levels of three markers in the blood, there is not a finite range for this parameter. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo oral capsules taken one daily for 52 weeks
Placebo: Matching placebo oral capsule | 75 |
| Icosabutate 300mg Icosabutate 300mg oral capsule taken once daily for 52 weeks
Icosabutate: Icosabutate oral capsule once daily | 76 |
| Icosabutate 600mg Icosabutate 600mg oral capsules taken once daily for 52 weeks
Icosabutate: Icosabutate oral capsule once daily | 77 |
| Total | 228 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 | 8 |
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 5 | 3 |
| Overall Study | Physician Decision | 0 | 1 | 0 |
| Overall Study | Pregnancy | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 0 |
| Overall Study | Reason not recorded | 0 | 1 | 0 |
| Overall Study | Requirement of prohibited concomitant medication | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 5 | 6 |
Baseline characteristics
| Characteristic | Placebo | Icosabutate 300mg | Icosabutate 600mg | Total |
|---|---|---|---|---|
| Age, Continuous | 54.0 years STANDARD_DEVIATION 11.15 | 53.3 years STANDARD_DEVIATION 10.52 | 51.8 years STANDARD_DEVIATION 10.26 | 53.0 years STANDARD_DEVIATION 10.64 |
| Alcohol use Current | 44 Participants | 40 Participants | 40 Participants | 124 Participants |
| Alcohol use Former | 10 Participants | 8 Participants | 12 Participants | 30 Participants |
| Alcohol use Missing | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Alcohol use Never | 20 Participants | 28 Participants | 25 Participants | 73 Participants |
| Body mass index | 35.94 kg/m^2 STANDARD_DEVIATION 6.23 | 36.73 kg/m^2 STANDARD_DEVIATION 5.732 | 37.32 kg/m^2 STANDARD_DEVIATION 6.047 | 36.67 kg/m^2 STANDARD_DEVIATION 6.006 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants | 31 Participants | 29 Participants | 92 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 44 Participants | 45 Participants | 131 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 72 Participants | 72 Participants | 71 Participants | 215 Participants |
| Sex: Female, Male Female | 52 Participants | 55 Participants | 51 Participants | 158 Participants |
| Sex: Female, Male Male | 23 Participants | 21 Participants | 26 Participants | 70 Participants |
| Type 2 Diabetes status Diabetic | 35 Participants | 40 Participants | 39 Participants | 114 Participants |
| Type 2 Diabetes status Non-diabetic | 40 Participants | 36 Participants | 38 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 91 | 0 / 92 | 1 / 95 |
| other Total, other adverse events | 82 / 91 | 80 / 92 | 80 / 95 |
| serious Total, serious adverse events | 4 / 91 | 5 / 92 | 8 / 95 |
Outcome results
Primary
Percentage of Patients With Resolution of NASH, Defined as Disappearance of Ballooning (Score = 0) With Lobular Inflammation Score 0 or 1, With no Worsening of Fibrosis.
Time frame: 52 weeks
Population: 3-Panel Modified Intent-To-Treat (mITT) Population - The 3-Panel mITT Population included all patients who had a baseline and Week 52 (or ET, if applicable) liver biopsy read and fulfilled eligibility criteria based on the 3-panel read paradigm. This population was considered the primary population for the efficacy analysis of the histology data.~Biopsy fibrosis score F2/F3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Patients With Resolution of NASH, Defined as Disappearance of Ballooning (Score = 0) With Lobular Inflammation Score 0 or 1, With no Worsening of Fibrosis. | 8.7 percentage of participants |
| Icosabutate 300mg | Percentage of Patients With Resolution of NASH, Defined as Disappearance of Ballooning (Score = 0) With Lobular Inflammation Score 0 or 1, With no Worsening of Fibrosis. | 17.3 percentage of participants |
| Icosabutate 600mg | Percentage of Patients With Resolution of NASH, Defined as Disappearance of Ballooning (Score = 0) With Lobular Inflammation Score 0 or 1, With no Worsening of Fibrosis. | 20.8 percentage of participants |
p-value: 0.299195% CI: [0.62, 4.63]Cochran-Mantel-Haenszel
p-value: 0.138695% CI: [0.8, 5.08]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in Composite Disease Activity Score (Composite NASH Score of Inflammation, Ballooning, Fibrosis)
The disease activity score can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2). The higher the score the more severe the disease.
Time frame: 52 weeks
Population: Results are presented for those participants in the 3-panel mITT population who had results for these parameters at Week 52.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Composite Disease Activity Score (Composite NASH Score of Inflammation, Ballooning, Fibrosis) | -0.2 score on a scale | Standard Deviation 1.68 |
| Icosabutate 300mg | Change From Baseline in Composite Disease Activity Score (Composite NASH Score of Inflammation, Ballooning, Fibrosis) | -0.7 score on a scale | Standard Deviation 1.84 |
| Icosabutate 600mg | Change From Baseline in Composite Disease Activity Score (Composite NASH Score of Inflammation, Ballooning, Fibrosis) | -0.9 score on a scale | Standard Deviation 1.56 |
Secondary
Change From Baseline in Fibrosis Activity Marker Enhanced Liver Fibrosis (ELF) Test
ELF is a blood test that measures liver fibrosis by analyzing three markers in the blood: Hyaluronic acid (HA), Procollagen III amino-terminal peptide (PIIINP), and Tissue inhibitor of matrix metalloproteinase 1 (TIMP-1). The higher the score the higher the levels of markers in the blood. ELF score = 2.278 + 0.851 × ln(HA) + 0.751 × ln(PIIINP) + 0.394 × ln(TIMP-1). As the score is a composite measure of the levels of three markers in the blood, there is not a finite range for this parameter.
Time frame: 52 weeks
Population: Results are presented for those participants in the 3-panel mITT population who had results for these parameters at Week 52.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fibrosis Activity Marker Enhanced Liver Fibrosis (ELF) Test | -0.051 score | Standard Error 0.0993 |
| Icosabutate 300mg | Change From Baseline in Fibrosis Activity Marker Enhanced Liver Fibrosis (ELF) Test | -0.125 score | Standard Error 0.1087 |
| Icosabutate 600mg | Change From Baseline in Fibrosis Activity Marker Enhanced Liver Fibrosis (ELF) Test | -0.370 score | Standard Error 0.0983 |
Secondary
Change From Baseline in Fibrosis Activity Marker Pro-C3
Time frame: 52 weeks
Population: Results are presented for those participants in the 3-panel mITT population who had results for this parameter at Week 52
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fibrosis Activity Marker Pro-C3 | -4.33 micrograms/L | Standard Error 2.83 |
| Icosabutate 300mg | Change From Baseline in Fibrosis Activity Marker Pro-C3 | -3.68 micrograms/L | Standard Error 3.023 |
| Icosabutate 600mg | Change From Baseline in Fibrosis Activity Marker Pro-C3 | -11.76 micrograms/L | Standard Error 2.762 |
Secondary
Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR is a measure of insulin resistance and metabolic status. The higher the score, the higher the level of insulin resistance. HOMA-IR = fasting glucose \[mmol/L)\] × fasting insulin \[mIU/L\]/22.5. As HOMA-IR is a composite score using 2 parameters, it does not have a finite range.
Time frame: 52 weeks
Population: 3-panel mITT population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 0.609 score | Standard Error 1.3453 |
| Icosabutate 300mg | Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | -2.810 score | Standard Error 1.4733 |
| Icosabutate 600mg | Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | -3.794 score | Standard Error 1.3203 |
Secondary
Change From Baseline in Inflammation Marker hsCRP
Time frame: 52 weeks
Population: 3-panel mITT population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Inflammation Marker hsCRP | 1.089 mg/L | Standard Error 0.8095 |
| Icosabutate 300mg | Change From Baseline in Inflammation Marker hsCRP | -1.297 mg/L | Standard Error 0.8953 |
| Icosabutate 600mg | Change From Baseline in Inflammation Marker hsCRP | -3.382 mg/L | Standard Error 0.7978 |
Secondary
Change From Baseline in Magnetic Resonance Imaging-Proton Density-Fat Fraction (MRI-PDFF)
MRI-PDFF is a quantitative imaging biomarker that measures the fat fraction of tissue by correcting factors influencing magnetic resonance signal intensity.
Time frame: 52 weeks
Population: Results are presented for those participants in the 3-panel mITT population who had results for these parameters at Week 52.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Magnetic Resonance Imaging-Proton Density-Fat Fraction (MRI-PDFF) | -4.37 Percentage of fat | Standard Deviation 7.185 |
| Icosabutate 300mg | Change From Baseline in Magnetic Resonance Imaging-Proton Density-Fat Fraction (MRI-PDFF) | -1.33 Percentage of fat | Standard Deviation 5.356 |
| Icosabutate 600mg | Change From Baseline in Magnetic Resonance Imaging-Proton Density-Fat Fraction (MRI-PDFF) | -0.95 Percentage of fat | Standard Deviation 8.206 |
Secondary
Change From Baseline in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)
A histological scoring system that assesses a liver biopsy and gives scores for steatosis (0-3), lobular inflammation (0-3), and hepatocyte ballooning (0-2) giving a total score of (0-8). The higher the score the more severe the disease
Time frame: 52 weeks
Population: Results are presented for those participants in the 3-panel mITT population who had results for these parameters at Week 52.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) | -0.9 score on a scale | Standard Deviation 1.36 |
| Icosabutate 300mg | Change From Baseline in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) | -0.9 score on a scale | Standard Deviation 1.51 |
| Icosabutate 600mg | Change From Baseline in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) | -1.3 score on a scale | Standard Deviation 1.65 |
Secondary
Change in Bilirubin Micromol/L From Baseline
Time frame: 52 weeks
Population: Results are presented for those participants in the 3-panel mITT population who had results for this parameter at Week 52
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Bilirubin Micromol/L From Baseline | 0.56 micromol/L | Standard Error 0.332 |
| Icosabutate 300mg | Change in Bilirubin Micromol/L From Baseline | -1.11 micromol/L | Standard Error 0.362 |
| Icosabutate 600mg | Change in Bilirubin Micromol/L From Baseline | -1.49 micromol/L | Standard Error 0.325 |
Secondary
Changes in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline
Changes in scores for the individual component parts of the Nonalcoholic fatty liver disease (NAFLD) activity score (NAS) as judged by a pathologist examining sections from a liver biopsy; steatosis (range 0-3), lobular inflammation (range 0-3), and hepatocyte ballooning (range 0-2) In all cases a higher number denotes more severe disease activity
Time frame: 52 weeks
Population: 3-panel mITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Changes in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline | Lobular inflammation score | -0.2 score on a scale | Standard Deviation 0.62 |
| Placebo | Changes in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline | Steatosis grade | -0.4 score on a scale | Standard Deviation 0.62 |
| Placebo | Changes in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline | Hepatocyte ballooning score | -0.3 score on a scale | Standard Deviation 0.79 |
| Icosabutate 300mg | Changes in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline | Lobular inflammation score | -0.4 score on a scale | Standard Deviation 0.67 |
| Icosabutate 300mg | Changes in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline | Steatosis grade | -0.2 score on a scale | Standard Deviation 0.65 |
| Icosabutate 300mg | Changes in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline | Hepatocyte ballooning score | -0.3 score on a scale | Standard Deviation 0.84 |
| Icosabutate 600mg | Changes in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline | Steatosis grade | -0.4 score on a scale | Standard Deviation 0.81 |
| Icosabutate 600mg | Changes in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline | Hepatocyte ballooning score | -0.4 score on a scale | Standard Deviation 0.78 |
| Icosabutate 600mg | Changes in Individual Histological Scores for Steatosis, Ballooning, Inflammation, and Fibrosis From Baseline | Lobular inflammation score | -0.5 score on a scale | Standard Deviation 0.61 |
Secondary
Changes in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline
Time frame: 52 weeks
Population: Results are presented for those participants in the 3-panel mITT population who had results for these parameters at Week 52.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Changes in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline | Alanine Aminotransferase | -9.8 U/L | Standard Error 3.73 |
| Placebo | Changes in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline | Aspartate Aminotransferase | -8.2 U/L | Standard Error 3.18 |
| Placebo | Changes in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline | Gamma Glutamyl Transferase | -5.1 U/L | Standard Error 5.41 |
| Icosabutate 300mg | Changes in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline | Alanine Aminotransferase | -27.9 U/L | Standard Error 4.05 |
| Icosabutate 300mg | Changes in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline | Aspartate Aminotransferase | -14.9 U/L | Standard Error 3.46 |
| Icosabutate 300mg | Changes in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline | Gamma Glutamyl Transferase | -27.9 U/L | Standard Error 5.75 |
| Icosabutate 600mg | Changes in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline | Aspartate Aminotransferase | -18.5 U/L | Standard Error 3.13 |
| Icosabutate 600mg | Changes in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline | Gamma Glutamyl Transferase | -32.7 U/L | Standard Error 5.26 |
| Icosabutate 600mg | Changes in the Liver Enzymes Aspartate Aminotransferase (AST)U/L, Alanine Aminotransferase ( ALT)U/L and Gamma Glutamyl Transferase (GGT) U/L From Baseline | Alanine Aminotransferase | -30.1 U/L | Standard Error 3.65 |
Secondary
Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement.
Time frame: 52 weeks
Population: 3-Panel mITT population. Biopsy fibrosis score F2/F3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement. | 13.0 percentage of participants |
| Icosabutate 300mg | Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement. | 30.8 percentage of participants |
| Icosabutate 600mg | Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement. | 28.3 percentage of participants |
Secondary
Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement and no Worsening of Steatohepatitis (Inflammation/Ballooning).
Time frame: 52 weeks
Population: 3-Panel mITT population. Biopsy fibrosis score F2/F3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement and no Worsening of Steatohepatitis (Inflammation/Ballooning). | 13.0 percentage of participants |
| Icosabutate 300mg | Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement and no Worsening of Steatohepatitis (Inflammation/Ballooning). | 26.9 percentage of participants |
| Icosabutate 600mg | Percentage of Patients With Fibrosis Improvement, Defined as Greater Than or Equal to 1 Stage of Fibrosis Improvement and no Worsening of Steatohepatitis (Inflammation/Ballooning). | 24.5 percentage of participants |