ION775 for High Triglycerides
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ION775 to evaluate its effects on individuals with high triglycerides, fats in the blood that can lead to heart problems. The study focuses on participants with high triglycerides, particularly those with very high levels, who are already taking cholesterol-lowering medications. Participants will receive ION775 by injection to determine if this treatment can effectively lower triglyceride levels. Individuals with high triglycerides who are on medication but still struggle to manage their levels might find this trial suitable. As a Phase 2 trial, the research aims to measure the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that ION775 is likely to be safe for humans?
An earlier study tested ION775 on healthy individuals with slightly high triglycerides. The results showed that the treatment was generally safe and well-tolerated, with most participants experiencing no serious side effects. Some minor side effects occurred, but they did not pose major safety concerns.
ION775 is now in a Phase 2 trial, indicating some evidence of its safety for humans. Phase 2 trials build on initial safety findings from earlier studies. These trials aim to confirm the treatment's tolerability and further assess its safety.
Although long-term data is not yet available, researchers are closely monitoring the treatment for any negative effects. Participants in the trial will contribute valuable information on the safety of ION775 for treating high triglyceride levels.12345Why do researchers think this study treatment might be promising for high triglycerides?
Unlike the standard treatments for high triglycerides, which often include statins, fibrates, or omega-3 fatty acids, ION775 offers a novel approach by targeting triglycerides through a unique mechanism. ION775 is administered via subcutaneous injection, which may provide a more direct and potentially more effective delivery compared to oral medications. Researchers are particularly excited about ION775 because it represents a new class of medication that could offer improved outcomes for patients who do not respond well to existing therapies. This innovative approach could pave the way for more personalized and effective management of high triglyceride levels.
What evidence suggests that ION775 might be an effective treatment for high triglycerides?
Research has shown that treatments like ION775 yield promising results in lowering triglyceride levels. In this trial, participants will receive ION775 through subcutaneous injection in different cohorts. Studies on a similar drug, Olezarsen, found up to a 72% reduction in fasting triglycerides compared to a placebo over six months. Another study reported an average decrease of about 61% in triglyceride levels. These reductions persisted over time and correlated with fewer cases of acute pancreatitis. Researchers found no major safety issues in these studies, which enhances confidence in the treatment's potential effectiveness.26789
Are You a Good Fit for This Trial?
This trial is for adults with high or very high fasting triglyceride levels (at least 350 mg/dL), who are already taking standard cholesterol-lowering medications.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ION775 by subcutaneous injection for 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ION775
Trial Overview
The study is testing a new drug called ION775 to see how well it lowers fasting triglyceride levels in people with hypertriglyceridemia. Participants will receive the medication and be monitored for safety and effectiveness.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants will be randomized to receive ION775 by SC injection.
Participants will be randomized to receive ION775 by SC injection.
Participants will be randomized to receive ION775 by subcutaneous (SC) injection.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ionis Pharmaceuticals, Inc.
Lead Sponsor
Dr. Brett P. Monia
Ionis Pharmaceuticals, Inc.
Chief Executive Officer since 2020
PhD in Pharmacology from the University of Pennsylvania, BSc in Molecular Biology and Analytical Chemistry from Stockton State College
Dr. Eric Bastings
Ionis Pharmaceuticals, Inc.
Chief Medical Officer
MD
Citations
NCT07604974 | A Study to Assess the Safety, Tolerability ...
The main objective of this study is to evaluate the effect of ION775 on fasting triglyceride (TG) levels in participants with ...
2.
clinicaltrialsarena.com
clinicaltrialsarena.com/news/sobi-ionis-tryngolza-severe-hypertriglyceridemia-phase-iii-results/Tryngolza shows efficacy in severe hypertriglyceridemia as ...
Sobi and Ionis' Tryngolza reduced the risk of acute pancreatitis by 85% in patients with severe hypertriglyceridemia during a pivotal Phase III ...
3.
ir.ionis.com
ir.ionis.com/news-releases/news-release-details/groundbreaking-pivotal-study-results-olezarsen-severeGroundbreaking pivotal study results of olezarsen for ...
Up to 72% placebo-adjusted mean reduction in fasting triglyceride levels at six months, with reductions sustained through 12 months –.
Olezarsen for Hypertriglyceridemia in Patients at High ...
Olezarsen significantly reduced levels of triglycerides, apolipoprotein B, and non-HDL cholesterol, with no major safety concerns identified.
5.
finance.yahoo.com
finance.yahoo.com/sectors/healthcare/articles/tryngolza-shows-efficacy-severe-hypertriglyceridemia-113422470.htmlTryngolza shows efficacy in severe hypertriglyceridemia as ...
Overall, 85% of patients treated with Tryngolza achieved triglyceride levels lower than 10 mmol/L – a cutoff point in which the European ...
218614Orig1s000 - accessdata.fda.gov
The relationship between APOC3 and liver steatosis or metabolic dysfunction-associated steatotic liver disease (MASLD) is conflicting across.
Safety Profile | TRYNGOLZA® (olezarsen) Injection
Review the safety profile of TRYNGOLZA®, evaluated in adult patients with FCS and learn more about known side effects here. See Full Safety & PI.
ion775 - larvol delta
... triglycerides with favorable safety and tolerability in healthy volunteers with moderately elevated triglycerides. Ionis is on track to initiate a Phase 2 ...
ION775 for High Triglycerides
The study is testing a new drug called ION775 to see how well it lowers fasting triglyceride levels in people with hypertriglyceridemia.
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