A Study to Assess the Safety, Tolerability and Efficacy of ION775
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIonis Pharmaceuticals, Inc.
About this trial
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
Qualifiers
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.
Disqualifiers
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 m².
Trial design
Treatments tested in this trial
- ION775
Treatment groups
72 Participants
are divided into 3 treatment groupsLocations
16Canada
Ionis Investigative SiteG1V 4W2, Québec Canada
United States
California
Ionis Investigative Site95648, Lincoln United States
Colorado
Ionis Investigative Site80045, Aurora United States
Florida
Ionis Investigative Site33434, Boca Raton United States
Sponsors and collaborators
Ionis Pharmaceuticals, Inc.
Lead sponsor
Source ClinicalTrials.gov