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



Status:Recruiting
Conditions:High Cholesterol, Gastrointestinal, Gastrointestinal, Diabetes, Diabetes, Metabolic
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology, Gastroenterology, Pharmacology / Toxicology
Healthy:No
Age Range:18 - 70
Updated:9/28/2018
Start Date:December 18, 2017
End Date:May 31, 2019
Contact:Akcea Therapeutics
Email:clinicalstudies@akceatx.com
Phone:617-207-0289

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A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Finding Study of ISIS 703802 (AKCEA-ANGPTL3-LRx) Administered Subcutaneously to Subjects With Hypertriglyceridemia, Type 2 Diabetes Mellitus (T2DM), and Nonalcoholic Fatty Liver Disease (NAFLD)

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 dosing regimens of ISIS 703802 on glucose and lipid metabolism, and liver
fat in subjects with Hypertriglyceridemia, Type 2 Diabetes Mellitus (T2DM), and Nonalcoholic
Fatty Liver Disease (NAFLD).


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 PPARᵞ 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)
We found this trial at
28
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8041 Hosbrook Road
Cincinnati, Ohio 45236
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Atlanta, Georgia 30322
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Austin, Texas 78735
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Boca Raton, Florida 33434
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Bridgeton, New Jersey 08302
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Carrollton, Texas 75010
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Chandler, Arizona 85224
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Charleston, South Carolina
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Chicago, Illinois 60153
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Chicago, IL
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Dallas, Texas 75390
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7250 France Avenue South
Edina, Minnesota 55435
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Fountain Hills, Arizona 85268
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Glendale, Arizona 85306
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Greensboro, North Carolina 27410
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Hamilton, Ontario
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Hamilton,
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High Point, North Carolina 27265
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Huntington Park, California 90255
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Hurst, Texas 76054
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Jupiter, Florida 33458
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Layton, Utah 84041
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Los Angeles, California 90033
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Louisville, Kentucky 40213
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4824 East Baseline Road
Mesa, Arizona 85206
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Montclair, California 91710
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Panorama City, California 91402
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Phoenix, Arizona 85016
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Port Saint Lucie, Florida 34952
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San Antonio, Texas 78229
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