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)
View Full Details on ClinicalTrials.gov
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NCT07604974
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