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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT04932512

Public ClinicalTrials.gov record NCT04932512. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:57 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Adaptive Two-Part Phase 2, Multi-Center, Randomized, Double Blind, Placebo-Controlled Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224 Administered Once Monthly in Adult Subjects With Confirmed Non-Alcoholic Steatohepatitis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04932512
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Ionis Pharmaceuticals, Inc.
Industry
Enrollment
160 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 17, 2021 (Actual)
Primary completion
Jan 10, 2024 (Actual)
Completion
Feb 28, 2024 (Actual)
Last update posted
Nov 27, 2024

2021 – 2024

United States locations

U.S. sites
50
U.S. states
16
U.S. cities
46
Facility City State ZIP Site status
Arizona Liver Health-Chandler Chandler Arizona 85224 —
Arizona Liver Health Glendale Arizona 85306 —
Arizona Liver Health Tucson Arizona 85712 —
Arkansas Gastroenterology - North Little Rock North Little Rock Arkansas 72117 —
GW Research, Inc. Chula Vista California 91910 —
National Research Institute - Gardena Gardena California 90247 —
National Research Institute Huntington Park California 90255 —
National Research Institute Los Angeles California 90057 —
National Research Institute Panorama City Panorama City California 91402 —
National Research Institute - Santa Ana Santa Ana California 92704 —
South Denver Gastroenterology, PC Englewood Colorado 80113 —
Excel Medical Clinical Trials, LLC Boca Raton Florida 33434 —
Tampa Bay Medical Research, Inc. Clearwater Florida 33761 —
Southwest General Medical Center Fort Myers Florida 33907 —
Evolution Clinical Trials, INC Hialeah Gardens Florida 33016 —
ClinCloud, LLC. Maitland Florida 32751 —
Advanced Pharma CR, LLC Miami Florida 33147 —
La Salud Research Miami Florida 33155 —
Entrust Clinical Research Miami Florida 33176 —
Floridian Clinical Research, LLC. Miami Lakes Florida 33016 —
Sensible Healthcare, LLC Ocoee Florida 34761 —
Covenant Metabolic Specialists, LLC Sarasota Florida 34240 —
Metabolic Research Institute, Inc. West Palm Beach Florida 33401 —
Gastrointestinal Specialists of Georgia Marietta Georgia 30060 —
Tandem Clinical Research GI Houma Louisiana 70363 —
Tandem Clinical Research GI, LLC. Marrero Louisiana 70072 —
Tandem Clinical Research GI Metairie Louisiana 70006 —
Delta Research Partners Monroe Louisiana 71201 —
Louisiana Research Center, LLC Shreveport Louisiana 71105 —
Southern Therapy and Advanced Research Jackson Mississippi 39216 —
Advanced Research Institute Reno Nevada 89511 —
Clarity Clinical Research East Syracuse New York 13057 —
Tandem Clinical Research GI, LLC. New York New York 10033 —
Cumberland Research Associates, LLC Fayetteville North Carolina 28304 —
Aventiv Research, Inc. Columbus Ohio 43213 —
Clinical Research Institute of Ohio Westlake Ohio 44145 —
WR-ClinSearch, LLC Chattanooga Tennessee 37421 —
Pinnacle Clinical Research Austin Texas 78757 —
South Texas Research Institute Brownsville Texas 78520 —
Dallas Diabetes Research Center Dallas Texas 75230 —
Velocity Clinical Research Dallas Texas 75230 —
South Texas Research Institute Edinburg Texas 78539 —
R&H Clinical Research, Inc. Katy Texas 77494 —
DHR Health Institute for Research and Development McAllen Texas 78504 —
Quality Research, Inc. San Antonio Texas 78209 —
Pinnacle Clinical Research San Antonio Texas 78229 —
Advanced Research Institute Ogden Utah 84405 —
Granger Medical Clinic Riverton Utah 84096 —
Advanced Research Institute Sandy City Utah 84092 —
Manassas Clinical Research Center Manassas Virginia 20110 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04932512, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 27, 2024 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04932512 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →