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

What this Trial Is About

Researchers are evaluating the effect of ION775 on fasting triglyceride levels in adults with hypertriglyceridemia (HTG) and severe hypertriglyceridemia (sHTG). This Phase 2 open-label trial aims to assess the safety, tolerability, and effectiveness of ION775 in lowering triglyceride levels in these conditions. The study is sponsored by Ionis Pharmaceuticals, Inc., and focuses on participants with elevated fasting triglycerides despite standard lipid-lowering treatments. Participants will be randomly assigned to one of three groups, all receiving ION775 by subcutaneous injection. The trial includes a 4-6 week screening period followed by a 6-month treatment phase where ION775 is administered, then a 6-month post-treatment follow-up to monitor longer-term effects and safety. The study does not include a placebo group, and all participants receive the investigational drug. During the study, participants will undergo fasting triglyceride measurements at baseline and month 6 to assess changes. Additional monitoring includes tracking treatment-emergent adverse events, clinical lab evaluations, and changes in related cholesterol markers such as apolipoprotein C-III, VLDL cholesterol, remnant cholesterol, and non-HDL cholesterol. Total participation lasts about 12 months, with safety and tolerability closely monitored throughout treatment and follow-up periods.

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