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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
ION775 will be administered by SC injection.
Ionis Investigative Site
Lincoln, California, United States
RECRUITINGIonis Investigative Site
Miami, Florida, United States
RECRUITINGIonis Investigative Site
Miramar, Florida, United States
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
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Ionis Investigative Site
Flint, Michigan, United States
RECRUITINGIonis Investigative Site
Munroe Falls, Ohio, United States
RECRUITINGIonis Investigative Site
Little River, South Carolina, United States
RECRUITINGIonis Investigative Site
Lampasas, Texas, United States
RECRUITINGIonis Investigative Site
San Antonio, Texas, United States
RECRUITING