Last updated on September 2018

Study of ISIS 703802 in Subjects With Hypertriglyceridemia Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: NIDDM | NAFLD | Fatty Liver | Hypertriglyceridemia | Nonalcoholic
  • Age: Between 18 - 70 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Plasma TG at Screening > 200 mg/dL and at qualification of 150 mg/dL
  • Documented history of hepatic steatosis with baseline MRI indicating hepatic fat fraction (HFF) 10%
  • Diagnosis of Type 2 Diabetes Mellitus with Hemoglobin A1c 7 and 10% at Screening
  • Must have been on a stable dose of Oral Antidiabetic Therapy for a minimum of 3 months prior to Screening
  • Body mass index between 27- 40 kg/m2, inclusive, at Screening

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Active chronic liver disease, alcoholic liver disease, Wilson's disease hemochromatosis, primary biliary cirrhosis, primary sclerosing cholangitis, genetic hemochromatosis, known or suspected hepatocellular carcinoma, history of or planned liver transplant for end-stage liver disease of any etiology
  • Documented history of advanced liver fibrosis
  • History of cirrhosis and/or hepatic decompensation including ascites, hepatic encephalopathy, or variceal bleeding
  • History of clinically significant acute cardiac event within 6 months before Screening
  • History of heart failure with NYHA greater than Class II
  • Use of Insulin or insulin analogs, GLP-1 agonists, and PPAR agonists (pioglitazone or rosiglitazone)
  • Weight change > 5% within 3 months before Screening
  • Conditions contraindicated for MRI procedures including any metal implant (e.g., heart pacemaker, rods, screws, aneurysm clips)

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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