Ion775 for high triglyceride levels: safety, tolerability, and how well it works

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, open-label, parallel-dose study to evaluate the safety, tolerability, and effect of ION775 on fasting triglyceride levels. The trial includes a 4-6 week screening period, a 6-month treatment period, and a 6-month post-treatment follow-up. Participants will continue standard of care lipid-lowering therapy while receiving ION775. Key exclusions include high HbA1c, elevated liver enzymes, high bilirubin not due to Gilbert's syndrome, and significantly reduced kidney function. The study is conducted at three Ionis investigative sites in the U.S. and is sponsored by Ionis Pharmaceuticals.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ionis Investigative Site
  Lincoln, California, United States Recruiting
• Ionis Investigative Site
  Aurora, Colorado, United States Recruiting
• Ionis Investigative Site
  Boca Raton, Florida, United States Recruiting
• Ionis Investigative Site
  Miami, Florida, United States Recruiting
• Ionis Investigative Site
  Miramar, Florida, United States Recruiting
• Ionis Investigative Site
  Columbus, Georgia, United States Recruiting

Study contacts

• Study coordinator: Ionis Pharmaceuticals, Inc.
• Email: IonisION775-CS2@clinicaltrialmedia.com
• Phone: 1-844-828-3770

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Solbinsiran injections to lower very high triglycerides

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• MAR001 for adults with high triglycerides and remnant cholesterol

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• JMT202 injections for adults with high triglycerides

  This will test whether repeated subcutaneous injections of JMT202 are safe and well tolerated in Chinese adults with high triglyceride levels.

  Recruiting Phase 1/2 Shanghai JMT-Bio Inc. · Beijing, Beijing Municipality · NCT07140809

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.