← Back to all trials
Recruiting
NCT07604974
A Study to Assess the Safety, Tolerability and Efficacy of ION775
Conditions: Hypertriglyceridemia, Severe Hypertriglyceridemia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 72
Sponsor: Ionis Pharmaceuticals, Inc.
Location: Ionis Investigative Site Lincoln California
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07604974). StuddyBuddy aggregates publicly available trial information.
