Back to resultsA Study of IDN-6556 in Subjects With NAFLD and Raised Transaminases (NAFLD)
Primary Purpose
Nonalcoholic Steatohepatitis, Non-alcoholic Fatty Liver Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IDN-6556
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nonalcoholic Steatohepatitis focused on measuring NAFLD, NASH
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
- Diagnosis of non-alcoholic fatty liver disease (NAFLD) as evidenced by imaging or other diagnostic assessments
- Alanine aminotransferase (ALT) levels ≥1.5 x ULN on at least two occasions, seven or more days apart, during the Screening period
- alpha-fetoprotein (AFP) ≤ 100 ng/mL
- Hemoglobin ≥10 g/dL, a platelet count ≥ 100 x 10^9/L, and a white blood cell count ≥ 3.0 x 10^9/L
- If on metformin, sulfonylureas, statins, or fibrates, subjects must be on a stable dose of these drugs for at least three months prior to Screening and during the study
Exclusion Criteria:
- Known infection with HIV, HCV, or HBV
Decompensated or severe liver disease as evidenced by one or more of the following:
- Confirmed cirrhosis or suspicion of cirrhosis
- Esophageal varices
- Ascites
- Suspicion of portal hypertension
- Hospitalization for liver disease within 60 days of screening
- Bilirubin >2 x ULN, or ALT or AST > 10 x ULN
- 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
Sites / Locations
- University of Miami
- Indiana University
- Henry Ford Hospital
- Mayo Clinic Rochester
- Kansas City Research Institute
- Mary Immaculate Hospital
- Bon Secours St. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
IDN-6556
Placebo
Arm Description
IDN-6556 capsules, 25 mg BID
Placebo BID
Outcomes
Primary Outcome Measures
Change in Alanine Aminotransferase (ALT)
Mean change in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo
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
Secondary Outcome Measures
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.
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
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
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
Full Information
NCT ID
NCT02077374
First Posted
February 28, 2014
Last Updated
July 25, 2016
Sponsor
Conatus Pharmaceuticals Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02077374
Brief Title
A Study of IDN-6556 in Subjects With NAFLD and Raised Transaminases
Acronym
NAFLD
Official Title
A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of IDN-6556 in Subjects With Non-Alcoholic Fatty Liver Disease and Raised Transaminases
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Conatus Pharmaceuticals Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis, Non-alcoholic Fatty Liver Disease
Keywords
NAFLD, NASH
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IDN-6556
Arm Type
Experimental
Arm Description
IDN-6556 capsules, 25 mg BID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo BID
Intervention Type
Drug
Intervention Name(s)
IDN-6556
Other Intervention Name(s)
emricasan, PF-03491390
Intervention Description
25 mg BID for 28 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo BID for 28 Days
Primary Outcome Measure Information:
Title
Change in Alanine Aminotransferase (ALT)
Description
Mean change in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo
Time Frame
Day 28/ET
Title
Relative Percent Change in Alanine Aminotransferase (ALT)
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
Secondary Outcome Measure Information:
Title
Change in Aspartate Aminotransferase (AST)
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
Title
Levels of cCK18/M30
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
Title
Levels of Caspase 3/7 RLU
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
Title
Levels of flCK18/M65
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
Diagnosis of non-alcoholic fatty liver disease (NAFLD) as evidenced by imaging or other diagnostic assessments
Alanine aminotransferase (ALT) levels ≥1.5 x ULN on at least two occasions, seven or more days apart, during the Screening period
alpha-fetoprotein (AFP) ≤ 100 ng/mL
Hemoglobin ≥10 g/dL, a platelet count ≥ 100 x 10^9/L, and a white blood cell count ≥ 3.0 x 10^9/L
If on metformin, sulfonylureas, statins, or fibrates, subjects must be on a stable dose of these drugs for at least three months prior to Screening and during the study
Exclusion Criteria:
Known infection with HIV, HCV, or HBV
Decompensated or severe liver disease as evidenced by one or more of the following:
Confirmed cirrhosis or suspicion of cirrhosis
Esophageal varices
Ascites
Suspicion of portal hypertension
Hospitalization for liver disease within 60 days of screening
Bilirubin >2 x ULN, or ALT or AST > 10 x ULN
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean L. Chan, MD
Organizational Affiliation
Conatus Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Kansas City Research Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Mary Immaculate Hospital
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Facility Name
Bon Secours St. Mary's Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30430605
Citation
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.
Results Reference
derived
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A Study of IDN-6556 in Subjects With NAFLD and Raised Transaminases
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