A Study to Assess ARI-3037MO on Hepatic Fat Metabolism in Patients With Dysglycemia and Evidence of Hepatic Steatosis

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Nonalcoholic Steatohepatitis

In brief

Primary objective To investigate the effect of a 24-week, twice daily dosing regimen of ARI-3037MO compared to placebo on plasma triglyceride (TG) levels, liver enzymes and hepatic fat content in patients with dysglycemia and hepatic steatosis due to nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH). Secondary Objective To investigate the safety and tolerability of a 24-week, twice daily dosing regimen of ARI-3037MO compared to placebo in patients with dysglycemia and evidence of NAFLD or NASH.

Key facts

Study ID

NCT02574325

Run by

Arisaph Pharmaceuticals Inc

People needed

11

Starts

2015-10-01

Expected to finish

2016-12-01

Last updated by the study team

2016-08-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients ≥ 18 years of age at study entry
• Female patients must be of nonchildbearing potential
• Have a stable diet and agree to maintain this diet throughout the study
• Have not gained or lost ≥ 10 lbs (4.5 kg) of body weight within 6months prior to Screening Visit 1
• Have a body mass index (BMI) between 28 and 45 kg.m-2, inclusive
• Have elevated alanine aminotransferase (ALT) levels. For men: 50 IU/L to 250 IU/L, inclusive. For women: 40 IU/L to 240 IU/L, inclusive.
• Have HbA1c of < 9.5
• Have a intrahepatic fat content of ≥ 10% confirmed by liver MRI
• If taking antidiabetic therapies (excluding thiazolidines as per exclusion Criterion No. 13), i.e., metformin, sulfonylureas, dipeptidyl peptidase-4 inhibitors, insulin; must be on a stable dose for at least 3months prior to Screening Visit 1. Similarly, if taking lipid lowering therapies; must be on a stable dose for at least 3 months prior to Screening Visit 1.
• Understands the study requirements and the treatment procedures, is willing to comply with all protocol-required evaluations and provides written informed consent before any study specific tests or procedures are performed

You may not qualify if…

• A history of hepatic disease such as chronic hepatitis C virus or concurrent active hepatitis B virus (i.e., serum positive for hepatitis B surface antigen)
• Autoimmune hepatitis
• Primary biliary cirrhosis
• Sclerosing cholangitis
• Hereditary hemochromatosis
• History of chronic / repeat blood transfusion (i.e., ≥ 20 units of blood)
• Alpha-1 anti-trypsin deficiency
• Wilson's disease
• Thyroid disease
• Bariatric surgery within 5 years prior to Screening Visit 1
• Hepatic disease due to substance abuse
• Have any concurrent disease or condition not listed above that, in the opinion of the PI, would make the patient unsuitable for participation in the study
• Currently taking thiazolidines (glitazone therapy, i.e., Rosiglitazone, Pioglitazone)
• Liver biopsy in the past 90 days with negative results for cirrhosis and steatosis
• No evidence of hepatic decompensation or elevated serum bilirubin > 1.5 times the upper limit of normal
• Estimated glomerular filtration rate < 60 mL/min according to the Modification of Diet in Renal Disease equation
• Known substance abuse
• Current smoker or a history of smoking (> 10 cigarettes, > 3 cigars or > 3 pipes/day)
• Current consumption of > 3 units of alcohol per day (> 21 units per week) for men and > 2 units of alcohol per day (> 14 units per week) for women
• Currently participating in another clinical study

Where it is running

• Gastroenterology & Hepatology CRU, St Louis University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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