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The purpose of this study is to determine the safety and efficacy of IDN-6556 compared to placebo in patients with diagnosed fat deposits in their liver (not caused by alcohol) and with abnormal liver tests
This is a double-blind, randomized study to evaluate the effects of IDN-6556 on serum transaminases and pharmacodynamics of IDN-6556 in subjects with non-alcoholic fatty liver disease with elevated alanine aminotransferase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDN-6556 | Experimental | IDN-6556 capsules, 25 mg BID |
|
| Placebo | Placebo Comparator | Placebo BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDN-6556 | Drug | 25 mg BID for 28 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Alanine Aminotransferase (ALT) | Mean change in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo | Day 28/ET |
| Relative Percent Change in Alanine Aminotransferase (ALT) | Back transformation from log-transformed analysis results to original scale in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo | Baseline to Day 28/ET |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Aspartate Aminotransferase (AST) | Difference in the change in aspartate aminotransferase (AST) from Baseline to Day 28/ET in units per liter (U/L) between IDN-6556 and placebo. | Day 28/ET |
| Levels of cCK18/M30 |
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Inclusion Criteria:
Exclusion Criteria:
Known infection with HIV, HCV, or HBV
Decompensated or severe liver disease as evidenced by one or more of the following:
Inflammatory bowel disease
Diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)
Hepatocellular carcinoma (HCC) at entry into the study
History of or active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
Significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal insufficiency, and/or serious psychiatric disease, that, in the opinion of the Investigator would preclude the subject from participating in and completing the study
History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 4-ounce glasses of wine or 14 12-ounce cans/bottles of beer or wine coolers), or other substance abuse within the prior two years
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| Name | Affiliation | Role |
|---|---|---|
| Jean L. Chan, MD | Conatus Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States | ||
| Indiana University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30430605 | Derived | Shiffman M, Freilich B, Vuppalanchi R, Watt K, Chan JL, Spada A, Hagerty DT, Schiff E. Randomised clinical trial: emricasan versus placebo significantly decreases ALT and caspase 3/7 activation in subjects with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2019 Jan;49(1):64-73. doi: 10.1111/apt.15030. Epub 2018 Nov 14. |
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38 subjects were randomized and treated (19 each arm). 2 subjects on placebo discontinued before Day 28 and 1 discontinued after Day 28, but returned for their Day 56 visit, so 17 subjects completed the study. However, all 38 were included in the analyses using the last results provided for the 2 subjects at early termination.
In total, 71 subjects were screened at 7 sites, and 38 subjects were randomized and treated to a BID treatment with either placebo or IDN-6556 25 mg with 19 subjects in each arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | IDN-6556 | IDN-6556 capsules, 25 mg IDN-6556: 25 mg BID for 28 days |
| FG001 | Placebo | Placebo Matching Placebo BID for 28 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IDN-6556 | IDN-6556 capsules, 25 mg IDN-6556: 25 mg BID for 28 days |
| BG001 | Placebo | Placebo Matching Placebo BID for 28 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Alanine Aminotransferase (ALT) | Mean change in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo | The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS. | Posted | Mean | Standard Deviation | U/L | Day 28/ET |
|
Adverse events data were collected up to Day 56.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IDN-6556 | IDN-6556 capsules, 25 mg IDN-6556: 25 mg BID for 28 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean L. Chan, MD | Conatus Pharmaceuticals Inc. | (858) 376-2632 | jchan@conatuspharma.com |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C487112 | 3-(2-(2-tert-butylphenylaminooxalyl)aminopropionylamino)-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid |
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| Placebo | Other | Placebo BID for 28 Days |
|
Difference in the change in Caspase-cleaved cytokeratin serum levels (cCK18/M30) in units per liter (U/L) from baseline to Day 28/ET between IDN-6556 and placebo
| Day 28/ET |
| Levels of Caspase 3/7 RLU | Difference in the change of caspase 3/7 (Relative Light Units) from baseline to Day 28/ET between IDN-6556 and Placebo | Day 28/ET |
| Levels of flCK18/M65 | Difference in the change in full-length cytokeratin 18 (flCK18/M65) in units per liter (U/L) from Baseline to Day 28/ET between IDN-6556 and placebo | Day 28/ET |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Kansas City Research Institute | Kansas City | Missouri | 64131 | United States |
| Mary Immaculate Hospital | Newport News | Virginia | 23602 | United States |
| Bon Secours St. Mary's Hospital | Richmond | Virginia | 23226 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Relative Percent Change in Alanine Aminotransferase (ALT) | Back transformation from log-transformed analysis results to original scale in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo | The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS. | Posted | Mean | Standard Deviation | Relative percent change | Baseline to Day 28/ET |
|
|
|
| Secondary | Change in Aspartate Aminotransferase (AST) | Difference in the change in aspartate aminotransferase (AST) from Baseline to Day 28/ET in units per liter (U/L) between IDN-6556 and placebo. | The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS. | Posted | Median | Full Range | U/L | Day 28/ET |
|
|
|
|
| Secondary | Levels of cCK18/M30 | Difference in the change in Caspase-cleaved cytokeratin serum levels (cCK18/M30) in units per liter (U/L) from baseline to Day 28/ET between IDN-6556 and placebo | The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS. | Posted | Median | Full Range | U/L | Day 28/ET |
|
|
|
|
| Secondary | Levels of Caspase 3/7 RLU | Difference in the change of caspase 3/7 (Relative Light Units) from baseline to Day 28/ET between IDN-6556 and Placebo | The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS. | Posted | Median | Full Range | RLU | Day 28/ET |
|
|
|
|
| Secondary | Levels of flCK18/M65 | Difference in the change in full-length cytokeratin 18 (flCK18/M65) in units per liter (U/L) from Baseline to Day 28/ET between IDN-6556 and placebo | The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS. | Posted | Median | Full Range | U/L | Day 28/ET |
|
|
|
|
| 1 |
| 19 |
| 10 |
| 19 |
| EG001 | Placebo | Placebo Matching Placebo BID for 28 days | 1 | 19 | 8 | 19 |
| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA (17.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
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| Monoclonal B-cell lymphocytosis | Blood and lymphatic system disorders | MedDRA (17.0) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA (17.0) | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA (17.0) | Systematic Assessment |
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| Local Swelling | General disorders | MedDRA (17.0) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (17.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (17.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
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