A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224

Completed · Phase 2 · Has a placebo group

Conditions studied: Steatohepatitis, Nonalcoholic

In brief

The purpose of this study is to assess the effect of multiple ION224 doses when administered by subcutaneous (SC) injection for 49 weeks (end of the treatment \[EOT\]) on non-alcoholic steatohepatitis (NASH) histologic improvement and to assess the effect on liver steatosis by magnetic resonance imaging-determined proton density fat fraction (MRI-PDFF), additional changes in NASH histologic features, liver biochemistry tests, and plasma lipid profile.

Key facts

Study ID

NCT04932512

Run by

Ionis Pharmaceuticals, Inc.

People needed

160

Starts

2021-06-17

Expected to finish

2024-02-28

Last updated by the study team

2024-11-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females greater than or equal to (≥) 18 and less than or equal to (≤) 75 years old at the time of informed consent
• Body mass index ≥ 25 kg/m\^2 and ≥ 22 kg/m\^2 for participants of Asian race, as assessed during screening
• Liver fat ≥ 10% as assessed by MRI-PDFF before randomization
• Presence of NASH confirmed by centrally read liver biopsy
• Weight loss < 5% after historical biopsy. Otherwise, weight loss < 5% in the previous 3 months prior to randomization
• ALT and AST ≤ 200 units per liter (U/L) and confirmed to be stable
• Total Bilirubin ≤ 1.3 milligrams per deciliter (mg/dL) and confirmed to be stable

You may not qualify if…

• Prior or planned (during the Study Period) bariatric surgery or previous bariatric surgery within 2 years prior to screening
• History of solid organ transplant
• Screening laboratory values that would render a participant unsuitable for inclusion, including but not limited to:
• Clinically significant albuminuria or proteinuria
• Positive test for blood on urinalysis
• Estimated glomerular filtration rate (eGFR) < 60 milliliters (mL)/minute (min)/1.73 square meter (m\^2)
• Hemoglobin A1c (HbA1c) > 9.5%
• Platelet count < 170 × 10\^9/liter (L)
• Diagnosis of Gilbert's syndrome
• Known history of or evidence of liver disease other than NASH
• Clinical evidence of liver decompensation
• Active SARS-CoV-2 infection (COVID-19) or confirmed SARS-CoV-2 infection-related complication within 8 weeks of Screening
• Uncontrolled arterial hypertension
• History of bleeding diathesis or coagulopathy
• Participants with known intolerance to magnetic resonance imaging (MRI) or with conditions contraindicated for MRI Procedures
• History of, or current hard drug or alcohol abuse within 2 years prior to Screening
• Use of drugs historically associated with NAFLD for more than 2 weeks in the year prior to Screening
• Use of obeticholic acid, ursodeoxycholic acid, icosapent ethyl, niacin, PCSK9 inhibitors, and bile acid sequestrants
• Participants taking the following medicines UNLESS on a stable dose:
• Anti-diabetic medications
• statins, fenofibrate, and ezetimibe
• Estrogen containing contraceptives
• Glucagon-like peptide (GLP)-1 agonists
• Pioglitazone
• Vitamin E at doses ≤ 800 international unit (IU)/day

Where it is running

• Arizona Liver Health — Glendale, Arizona, United States
• Arizona Liver Health — Tucson, Arizona, United States
• Arkansas Gastroenterology - North Little Rock — North Little Rock, Arkansas, United States
• GW Research, Inc. — Chula Vista, California, United States
• National Research Institute - Gardena — Gardena, California, United States
• National Research Institute — Huntington Park, California, United States
• National Research Institute — Los Angeles, California, United States
• National Research Institute Panorama City — Panorama City, California, United States
• National Research Institute - Santa Ana — Santa Ana, California, United States
• South Denver Gastroenterology, PC — Englewood, Colorado, United States
• Excel Medical Clinical Trials, LLC — Boca Raton, Florida, United States
• Tampa Bay Medical Research, Inc. — Clearwater, Florida, United States
• Southwest General Medical Center — Fort Myers, Florida, United States
• Evolution Clinical Trials, INC — Hialeah Gardens, Florida, United States
• ClinCloud, LLC. — Maitland, Florida, United States
• Advanced Pharma CR, LLC — Miami, Florida, United States
• La Salud Research — Miami, Florida, United States
• Entrust Clinical Research — Miami, Florida, United States
• Floridian Clinical Research, LLC. — Miami Lakes, Florida, United States
• Sensible Healthcare, LLC — Ocoee, Florida, United States
• Covenant Metabolic Specialists, LLC — Sarasota, Florida, United States
• Metabolic Research Institute, Inc. — West Palm Beach, Florida, United States
• Gastrointestinal Specialists of Georgia — Marietta, Georgia, United States
• Tandem Clinical Research GI — Houma, Louisiana, United States
• Arizona Liver Health-Chandler — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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