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NCT07604974PHASE2Recruiting

A Study to Assess the Safety, Tolerability and Efficacy of ION775

Ionis Pharmaceuticals, Inc.

Start Date

5/12/2026

Completion Date

3/1/2028

Summary

The main objective of this study is to evaluate the effect of ION775 on fasting triglyceride (TG) levels in participants with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (sHTG).

Detailed Description

This is an open-label, parallel-dose study consisting of a 4-6 week screening period, a 6-month treatment period and a 6-month post-treatment follow-up period.

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: 1. Adult males and females with HTG (fasting TG more than or equal to (≥) 350 milligrams per deciliter (mg/dL) \[3.95 millimoles per liter (mmol/L)\] or with sHTG (fasting TG ≥ 500 mg/dL \[5.65 mmol/L\]). 2. Participants should be on standard of care lipid-lowering medications per local guidelines. Key Exclusion Criteria: 1. Hemoglobin A1c (HbA1c) ≥ 8.5% at Screening. 2. Alanine aminotransferase or aspartate aminotransferase \> 2.0 × upper limit of normal. 3. Total bilirubin \> 1.5 upper limit of normal unless due to Gilbert's syndrome. 4. Estimated GFR \< 30 mL/min/1.73 m\^2. Note: Other protocol pre-specified inclusion/exclusion criteria may apply.

Interventions

DRUG

ION775

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Conditions

HypertriglyceridemiaSevere Hypertriglyceridemia

Locations

Ionis Investigative Site

Lincoln, California 95648

United States

Ionis Investigative Site

Aurora, Colorado 80045

United States

Ionis Investigative Site

Boca Raton, Florida 33434

United States

Ionis Investigative Site

Miami, Florida 33184

United States

Ionis Investigative Site

Miramar, Florida 33027

United States

Ionis Investigative Site

Columbus, Georgia 31904

United States

Ionis Investigative Site

Louisville, Kentucky 40213

United States

Ionis Investigative Site

Flint, Michigan 48504

United States

Ionis Investigative Site

Munroe Falls, Ohio 44262

United States

Ionis Investigative Site

Little River, South Carolina 29566

United States

Ionis Investigative Site

Houston, Texas 77040

United States

Ionis Investigative Site

Lampasas, Texas 76550

United States

Ionis Investigative Site

McKinney, Texas 75071

United States

Ionis Investigative Site

Mesquite, Texas 75071

United States

Ionis Investigative Site

San Antonio, Texas 78209

United States

Ionis Investigative Site

Québec, G1V 4W2

Canada