A Study to Assess the Safety, Tolerability and Efficacy of ION775
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ION775.
- Who it may be relevant to
- Registry conditions: Hypertriglyceridemia, Severe Hypertriglyceridemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2, Open-label Trial Evaluating the Safety, Tolerability and Efficacy of ION775 in Adults With Hypertriglyceridemia
Overview
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).
Detailed description
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.
Interventions
- Drug ION775
ION775 will be administered by SC injection.
Primary outcome measures
- Percent Change From Baseline in Fasting Triglyceride (TG) [Time frame: Baseline, Month 6]
Secondary outcome measures (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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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 m\^2.
Note: Other protocol pre-specified inclusion/exclusion criteria may apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 15 centers
- Ionis Investigative Site — Lincoln
- Ionis Investigative Site — Aurora
- Ionis Investigative Site — Boca Raton
- Ionis Investigative Site — Miami
- Ionis Investigative Site — Miramar
- Ionis Investigative Site — Columbus
- Ionis Investigative Site — Louisville
- Ionis Investigative Site — Flint
- … and 7 more centers
Canada · 1 center
- Ionis Investigative Site — Québec
Identifiers
NCT: NCT07604974 · ION775-CS2