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NCT Number: NCT07604974

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

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).

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Key information

Conditions

Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Severe Hypertriglyceridemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ionis Investigative Site, Québec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

Note: Other protocol pre-specified inclusion/exclusion criteria may apply.

Treatment and study plan

ION775

Drug

ION775 will be administered by SC injection.

Primary outcomes

  1. Percent Change From Baseline in Fasting Triglyceride (TG)

    Time frame: Baseline, Month 6

Secondary outcomes

  1. Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to 12 Months

  2. Number of Participants who Experience Abnormalities in Clinical Laboratory Evaluations

    Time frame: Up to 12 Months

  3. Percent Change From Baseline in Fasting Apolipoprotein C-III (apoC-III)

    Time frame: Baseline, Month 6

  4. Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C)

    Time frame: Baseline, Month 6

  5. Percent Change From Baseline in Remnant Cholesterol When Directly Measured

    Time frame: Baseline, Month 6

  6. Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C)

    Time frame: Baseline, Month 6

Study contacts

Contact information is provided by the study sponsor or research team.

Ionis Pharmaceuticals, Inc.

CONTACT

[email protected]

1-844-828-3770

Sponsors and collaborators

Lead sponsor

Ionis Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 22, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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