A Phase 2 interventional study of ION775 in Hypertriglyceridemia and Severe Hypertriglyceridemia, sponsored by Ionis Pharmaceuticals, Inc.. Recruiting at 17 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Ionis Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment
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).
This is an open-label, parallel-dose study consisting of a 4-6 week screening period, a 6-month treatment period and a 6-month post-treatment follow-up period.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol pre-specified inclusion/exclusion criteria may apply.
Participants will be randomized to receive ION775 by subcutaneous (SC) injection.
Drug: ION775
Participants will be randomized to receive ION775 by SC injection.
Drug: ION775
Participants will be randomized to receive ION775 by SC injection.
Drug: ION775
ION775 will be administered by SC injection.
Percent Change From Baseline in Fasting Triglyceride (TG)
Time frame: Baseline, Month 6
Number of Participants With at Least One Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 12 Months
Number of Participants who Experience Abnormalities in Clinical Laboratory Evaluations
Time frame: Up to 12 Months
Percent Change From Baseline in Fasting Apolipoprotein C-III (apoC-III)
Time frame: Baseline, Month 6
Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C)
Time frame: Baseline, Month 6
Percent Change From Baseline in Remnant Cholesterol When Directly Measured
Time frame: Baseline, Month 6
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C)
Time frame: Baseline, Month 6
Plan to share: Yes — Ionis may share anonymized individual participant data, aggregated clinical data, and other types of data that support the results in this study. Data requests from qualified researchers will be considered once all three of the following criteria are met: (1) 12 months from marketing approval of the study drug in both the United States and European Union; (2) 18 months from conclusion of the study; and (3) 6 months from publication of study article. Access would be via a secure environment and is contingent upon approval of a research proposal and entry into an appropriate data use agreement. Requests to access data can be submitted via the website https://vivli.org/ourmember/ionis/.
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Ionis Pharmaceuticals, Inc.