Status:
COMPLETED
Study of ISIS 703802 in Participants With Hypertriglyceridemia, Type 2 Diabetes Mellitus, and Nonalcoholic Fatty Liver Disease
Lead Sponsor:
Akcea Therapeutics
Collaborating Sponsors:
Ionis Pharmaceuticals, Inc.
Conditions:
NAFLD
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 703802 and to assess the efficacy of different doses and...
Eligibility Criteria
Inclusion
- Key
- Plasma triglycerides (TG) at Screening greater than (\>)150 milligrams per deciliter (mg/dL) and at qualification of \>150 mg/dL.
- Documented history of hepatic steatosis with baseline magnetic resonance imaging (MRI) indicating hepatic fat fraction (HFF) greater than (\>) 8%.
- Diagnosis of Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) \>6.5 and less than or equal to (≤) 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 kilograms per meter square (kg/m\^2), inclusive, at Screening.
- Key
Exclusion
- 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 New York Heart Association (NYHA) greater than Class II.
- Use of Insulin or insulin analogs, glucagon-like peptide-1 (GLP-1) agonists, and peroxisome proliferator-activated receptor gamma (PPARᵞ) agonists (pioglitazone or rosiglitazone).
- Weight change \>5% within 3 months before Screening.
- Conditions contraindicated for magnetic resonance imaging (MRI) procedures including any metal implant (example, heart pacemaker, rods, screws, aneurysm clips).
Key Trial Info
Start Date :
December 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2020
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT03371355
Start Date
December 21 2017
End Date
February 24 2020
Last Update
February 1 2021
Active Locations (42)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Sites
Chandler, Arizona, United States, 85224
2
Clinical Site
Fountain Hills, Arizona, United States, 85268
3
Clinical Site
Glendale, Arizona, United States, 85306
4
Clinical Site
Mesa, Arizona, United States, 85206