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A Study of IDN-6556 in Subjects With NAFLD and Raised Transaminases (NAFLD)

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ClinicalTrials.gov Identifier: NCT02077374
Recruitment Status : Completed
First Posted : March 4, 2014
Results First Posted : July 21, 2016
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
Conatus Pharmaceuticals Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Nonalcoholic Steatohepatitis
Non-alcoholic Fatty Liver Disease
Interventions Drug: IDN-6556
Other: Placebo
Enrollment 38
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title IDN-6556 Placebo
Hide Arm/Group Description

IDN-6556 capsules, 25 mg

IDN-6556: 25 mg BID for 28 days

Placebo

Matching Placebo BID for 28 days

Period Title: Overall Study
Started 19 19
Completed 19 17
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             1
Protocol Violation             0             1
Arm/Group Title IDN-6556 Placebo Total
Hide Arm/Group Description

IDN-6556 capsules, 25 mg

IDN-6556: 25 mg BID for 28 days

Placebo

Matching Placebo BID for 28 days

Total of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  89.5%
16
  84.2%
33
  86.8%
>=65 years
2
  10.5%
3
  15.8%
5
  13.2%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 38 participants
46
(23 to 76)
55
(34 to 70)
52
(23 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
7
  36.8%
7
  36.8%
14
  36.8%
Male
12
  63.2%
12
  63.2%
24
  63.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 19 participants 38 participants
19 19 38
1.Primary Outcome
Title Change in Alanine Aminotransferase (ALT)
Hide Description Mean change in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo
Time Frame Day 28/ET
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IDN-6556 Placebo
Hide Arm/Group Description:

IDN-6556 capsules, 25 mg

IDN-6556: 25 mg BID for 28 days

Placebo

Matching Placebo BID for 28 days

Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: U/L
-37.8  (42.7) -14.9  (22.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IDN-6556, Placebo
Comments Statistical Analysis for the difference in mean change in alanine aminotransferase (ALT) from Baseline to Day28/ET between IDN-6556 and placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0195
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -17
Confidence Interval (2-Sided) 95%
-30.7 to -2.5
Estimation Comments Based on Hodges-Lehmann estimator
2.Primary Outcome
Title Relative Percent Change in Alanine Aminotransferase (ALT)
Hide Description 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
Time Frame Baseline to Day 28/ET
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IDN-6556 Placebo
Hide Arm/Group Description:

IDN-6556 capsules, 25 mg

IDN-6556: 25 mg Twice daily for 28 days

Placebo

Placebo: Placebo Twice daily for 28 Days

Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: Relative percent change
-39.2  (26.2) -13.9  (21.8)
3.Secondary Outcome
Title Change in Aspartate Aminotransferase (AST)
Hide Description 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.
Time Frame Day 28/ET
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IDN-6556 Placebo
Hide Arm/Group Description:

IDN-6556 capsules, 25 mg

IDN-6556: 25 mg BID for 28 days

Placebo

Matching Placebo BID for 28 days

Overall Number of Participants Analyzed 19 19
Median (Full Range)
Unit of Measure: U/L
-6.7
(-63.1 to 20.0)
-5.2
(-41.9 to 27.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IDN-6556, Placebo
Comments Statistical Analysis for the difference in change in aspartate aminotransferase (AST) from baseline to Day 28/ET between IDN-6556 and placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8724
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-14.5 to 11.2
Estimation Comments Based on Hodges-Lehmann estimator
4.Secondary Outcome
Title Levels of cCK18/M30
Hide Description 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
Time Frame Day 28/ET
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IDN-6556 Placebo
Hide Arm/Group Description:

IDN-6556 capsules, 25 mg

IDN-6556: 25 mg BID for 28 days

Placebo

Matching Placebo BID for 28 days

Overall Number of Participants Analyzed 19 19
Median (Full Range)
Unit of Measure: U/L
-183.0
(-640 to 190)
14.0
(-2056 to 571)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IDN-6556, Placebo
Comments Statistical Analysis for the difference in change for cCK18/M30 from Baseline to Day 28/ET between IDN-6556 and Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1149
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -145
Confidence Interval (2-Sided) 95%
-336 to 55
Estimation Comments Based on Hodges-Lehmann estimator
5.Secondary Outcome
Title Levels of Caspase 3/7 RLU
Hide Description Difference in the change of caspase 3/7 (Relative Light Units) from baseline to Day 28/ET between IDN-6556 and Placebo
Time Frame Day 28/ET
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IDN-6556 Placebo
Hide Arm/Group Description:

IDN-6556 capsules, 25 mg

IDN-6556: 25 mg BID for 28 days

Placebo

Matching Placebo BID for 28 days

Overall Number of Participants Analyzed 19 19
Median (Full Range)
Unit of Measure: RLU
-287.0
(-2194 to 417)
68.0
(-1779 to 1229)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IDN-6556, Placebo
Comments Statistical Analysis for the difference in change for caspase 3/7 from Baseline to Day 28/ET between IDN-6556 and Placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1365
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -250
Confidence Interval (2-Sided) 95%
-590 to 63
Estimation Comments Based on Hodges-Lehmann estimator
6.Secondary Outcome
Title Levels of flCK18/M65
Hide Description 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
Time Frame Day 28/ET
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title IDN-6556 Placebo
Hide Arm/Group Description:

IDN-6556 capsules, 25 mg

IDN-6556: 25 mg BID for 28 days

Placebo

Placebo: Placebo BID for 28 Days

Overall Number of Participants Analyzed 19 19
Median (Full Range)
Unit of Measure: U/L
-296.0
(-1216 to 225)
4.0
(-2364 to 724)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IDN-6556, Placebo
Comments Statistical Analysis of the difference in the change in full-length cytokeratine 18 (flCK18/M65) from Baseline to Day 28/ET between IDN-6556 and placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0471
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -327
Confidence Interval (2-Sided) 95%
-628 to -7
Estimation Comments Based on Hodges-Lehmann estimator
Time Frame Adverse events data were collected up to Day 56.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IDN-6556 Placebo
Hide Arm/Group Description

IDN-6556 capsules, 25 mg

IDN-6556: 25 mg BID for 28 days

Placebo

Matching Placebo BID for 28 days

All-Cause Mortality
IDN-6556 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IDN-6556 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/19 (5.26%)      1/19 (5.26%)    
Gastrointestinal disorders     
Gastrointestinal haemorrhage  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Skin and subcutaneous tissue disorders     
Cellulitis  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IDN-6556 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/19 (52.63%)      8/19 (42.11%)    
Blood and lymphatic system disorders     
Haemorrhagic anaemia  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Monoclonal B-cell lymphocytosis  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Endocrine disorders     
Hyperthyroidism  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Frequent bowel movements  1  2/19 (10.53%)  2 0/19 (0.00%)  0
Abdominal pain upper  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Diarrhoea  1  1/19 (5.26%)  1 1/19 (5.26%)  1
Dry mouth  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Dyspepsia  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Flatulence  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Haematochezia  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Nausea  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Vomiting  1  1/19 (5.26%)  1 0/19 (0.00%)  0
General disorders     
Chest pain  1  2/19 (10.53%)  2 0/19 (0.00%)  0
Injection site erythema  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Injection site pain  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Injection site swelling  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Local Swelling  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Oedema peripheral  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Pyrexia  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Infections and infestations     
Bronchitis  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Cellulitis  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Pharyngitis streptococcal  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Urinary tract infection  1  1/19 (5.26%)  1 2/19 (10.53%)  2
Viral upper respiratory tract infection  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Groin pain  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Pain in extremity  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Nervous system disorders     
Hypoaesthesia  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Headache  1  2/19 (10.53%)  2 0/19 (0.00%)  0
Renal and urinary disorders     
Renal failure acute  1  1/19 (5.26%)  1 0/19 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Nasal congestion  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Sinus congestion  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Skin and subcutaneous tissue disorders     
Psoriasis  1  0/19 (0.00%)  0 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jean L. Chan, MD
Organization: Conatus Pharmaceuticals Inc.
Phone: (858) 376-2632
Responsible Party: Conatus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT02077374     History of Changes
Other Study ID Numbers: IDN-6556-06
First Submitted: February 28, 2014
First Posted: March 4, 2014
Results First Submitted: March 30, 2016
Results First Posted: July 21, 2016
Last Update Posted: August 30, 2016