A Study of IDN-6556 in Subjects With NAFLD and Raised Transaminases
NAFLD
A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of IDN-6556 in Subjects With Non-Alcoholic Fatty Liver Disease and Raised Transaminases
1 other identifier
interventional
38
1 country
7
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2014
Shorter than P25 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedFirst Posted
Study publicly available on registry
March 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
July 21, 2016
CompletedAugust 30, 2016
July 1, 2016
1 year
February 28, 2014
March 30, 2016
July 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (4)
Change in Aspartate Aminotransferase (AST)
Day 28/ET
Levels of cCK18/M30
Day 28/ET
Levels of Caspase 3/7 RLU
Day 28/ET
Levels of flCK18/M65
Day 28/ET
Study Arms (2)
IDN-6556
EXPERIMENTALIDN-6556 capsules, 25 mg BID
Placebo
PLACEBO COMPARATORPlacebo BID
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
University of Miami
Miami, Florida, 33136, United States
Indiana University
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
Related Publications (1)
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.
PMID: 30430605DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jean L. Chan, MD
- Organization
- Conatus Pharmaceuticals Inc.
Study Officials
- STUDY DIRECTOR
Jean L. Chan, MD
Conatus Pharmaceuticals Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2014
First Posted
March 4, 2014
Study Start
March 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
August 30, 2016
Results First Posted
July 21, 2016
Record last verified: 2016-07