RecruitingPhase 2NCT07604974

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

A Phase 2, Open-label Trial Evaluating the Safety, Tolerability and Efficacy of ION775 in Adults With Hypertriglyceridemia


Sponsor

Ionis Pharmaceuticals, Inc.

Enrollment

72 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 \[5.65 mmol/L\]).
  • Participants should be on standard of care lipid-lowering medications per local guidelines.

Exclusion Criteria4

  • Hemoglobin A1c (HbA1c) ≥ 8.5% at Screening.
  • Alanine aminotransferase or aspartate aminotransferase > 2.0 × upper limit of normal.
  • Total bilirubin > 1.5 upper limit of normal unless due to Gilbert's syndrome.
  • Estimated GFR < 30 mL/min/1.73 m\^2.

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Interventions

DRUGION775

ION775 will be administered by SC injection.


Locations(8)

Ionis Investigative Site

Lincoln, California, United States

Ionis Investigative Site

Miami, Florida, United States

Ionis Investigative Site

Miramar, Florida, United States

Ionis Investigative Site

Flint, Michigan, United States

Ionis Investigative Site

Munroe Falls, Ohio, United States

Ionis Investigative Site

Little River, South Carolina, United States

Ionis Investigative Site

Lampasas, Texas, United States

Ionis Investigative Site

San Antonio, Texas, United States

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NCT07604974


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