Actively Recruiting
Phase 2 Open-Label Study of ION775 by Injection in Adults With High or Severe High Triglycerides
Led by Ionis Pharmaceuticals, Inc. · Updated on 2026-06-18
72
Participants Needed
16
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of ION775 on fasting triglyceride levels in adults with hypertriglyceridemia and severe hypertriglyceridemia. This phase 2, open-label study aims to assess the safety, tolerability, and efficacy of ION775 in reducing triglyceride levels in these participants. The study is sponsored by Ionis Pharmaceuticals, Inc. Participants will be randomly assigned to one of three groups receiving ION775 by subcutaneous injection. The study includes a 4 to 6 week screening period, followed by a 6-month treatment period where participants receive ION775, and then a 6-month post-treatment follow-up period to monitor outcomes and safety. The study measures changes in fasting triglycerides and other cholesterol-related markers. During the study, participants will have assessments at baseline and at month 6 to measure triglyceride levels and other cholesterol components such as apolipoprotein C-III, very low-density lipoprotein cholesterol, remnant cholesterol, and non-high-density lipoprotein cholesterol. Safety is monitored through treatment-emergent adverse events and laboratory evaluations up to 12 months. Participants are involved in regular visits during the treatment and follow-up periods to evaluate the effects and safety of ION775.
CONDITIONS
Brief Title
A Study to Assess the Safety, Tolerability and Efficacy of ION775
Research Team
I
Ionis Pharmaceuticals, Inc.
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