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

Non-alcoholic Fatty Liver Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02077374
• Other study ID #: IDN-6556-06
• Status: Completed
• Phase: Phase 2
• First received: February 28, 2014
• Last updated: October 29, 2015
• Start date: March 2014
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• Source: Conatus Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 109/L, and a white blood cell count = 3.0 x 109/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:

1. Confirmed cirrhosis or suspicion of cirrhosis

2. Esophageal varices

3. Ascites

4. Suspicion of portal hypertension

5. Hospitalization for liver disease within 60 days of screening

6. 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Intervention

Drug:
• IDN-6556
25 mg BID for 28 days

Other:
• Placebo

Locations

Country	Name	City	State
United States	Mercy Medical Center	Baltimore	Maryland
United States	Henry Ford Hospital	Detroit	Michigan
United States	Indiana University	Indianapolis	Indiana
United States	Kansas City Research Institute	Kansas City	Missouri
United States	University of Miami	Miami	Florida
United States	Mary Immaculate Hospital	Newport News	Virginia
United States	Bon Secours St. Mary's Hospital	Richmond	Virginia
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Conatus Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in alanine aminotransferase from Baseline		28 days	No
Secondary	Changes in aspartate aminotransferase from Baseline		28 days	No
Secondary	Changes in biomarkers from Baseline	Levels of cCK18, flCK18, and caspase 3/7 will be evaluated	28 days	No
Secondary	Change in homeostatic model assessment-insulin resistance from Baseline		28 days	No