154 Participants Needed

Olezarsen for Cardiovascular Disease

Recruiting at 27 trial locations
IP
Overseen ByIonis Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Ionis Pharmaceuticals, Inc.
Must be taking: Lipid-lowering medications
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to continue taking their standard-of-care lipid-lowering medications as per local guidelines.

What is known about the safety of Olezarsen for cardiovascular disease?

Olezarsen, also known as volanesorsen, has been studied for its ability to lower triglyceride levels, which are fats in the blood linked to heart disease. While the research primarily focuses on its effectiveness, it is being evaluated in clinical trials for safety, and no major safety concerns have been highlighted in the available studies.12345

What is the purpose of this trial?

This trial is testing olezarsen, a medication aimed at lowering blood fats, in people with high triglycerides who are at risk for heart disease. The medication works by reducing proteins and fats in the blood to help lower cholesterol and triglyceride levels.

Eligibility Criteria

Inclusion Criteria

Participants must be willing to comply with diet and lifestyle recommendations as able
You have very high levels of triglycerides in your blood when fasting.
Participants must be on standard-of-care (SOC), lipid-lowering medications per local guidelines
See 1 more

Exclusion Criteria

You have been diagnosed with diabetes within the last 12 weeks.
Your HbA1c level is higher than 9.5% at the screening.
You have changed your basal insulin dose by more than 20% in the 3 months before the screening.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

8 weeks

Treatment

Participants receive olezarsen or placebo by subcutaneous injection every 4 weeks

53 weeks
13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 weeks

Treatment Details

Interventions

  • Olezarsen
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OlezarsenExperimental Treatment1 Intervention
Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection for up to 49 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Olezarsen-matching placebo will be administered once every 4 weeks by SC injection for up to 49 weeks.

Olezarsen is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Tryngolza for:
  • adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS)
🇪🇺
Approved in European Union as Olezarsen for:
  • treatment of familial chylomicronemia syndrome

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ionis Pharmaceuticals, Inc.

Lead Sponsor

Trials
151
Recruited
27,800+
Dr. Brett P. Monia profile image

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 profile image

Dr. Eric Bastings

Ionis Pharmaceuticals, Inc.

Chief Medical Officer

MD

Findings from Research

In a clinical trial involving 114 patients with high triglyceride levels, olezarsen significantly reduced triglyceride levels by up to 60% compared to a 6% increase in the placebo group, demonstrating its efficacy in lowering triglycerides in patients at high risk for cardiovascular disease.
Olezarsen also led to significant reductions in other harmful lipoproteins and showed a good safety profile, with no major adverse effects on liver or kidney function, and only mild injection site reactions reported.
Apolipoprotein C-III reduction in subjects with moderate hypertriglyceridaemia and at high cardiovascular risk.Tardif, JC., Karwatowska-Prokopczuk, E., Amour, ES., et al.[2022]
Volanesorsen, an antisense drug targeting apoC3 mRNA, significantly reduced levels of apoC-III on various lipoproteins (apoB, Lp(a), and apoA-I) by over 80% compared to placebo in patients with hypertriglyceridemia, indicating its potential efficacy in lowering cardiovascular risk.
The study utilized novel high-throughput ELISAs to measure lipoprotein-associated apoC-III, providing a new method for assessing cardiovascular risk factors and demonstrating that volanesorsen may effectively reduce triglycerides and associated cardiovascular risks.
Reduction in lipoprotein-associated apoC-III levels following volanesorsen therapy: phase 2 randomized trial results.Yang, X., Lee, SR., Choi, YS., et al.[2021]
Volanesorsen, an antisense oligonucleotide targeting APOC3 mRNA, has shown strong efficacy in significantly reducing both apoC-III production and triglyceride levels, which are crucial for managing severe hypertriglyceridemia.
Current phase 3 trials are evaluating the safety and effectiveness of volanesorsen, highlighting its potential as a new treatment option for patients at high risk of pancreatitis and cardiovascular disease due to elevated triglyceride levels.
APOC-III Antisense Oligonucleotides: A New Option for the Treatment of Hypertriglyceridemia.Schmitz, J., Gouni-Berthold, I.[2019]

References

Apolipoprotein C-III reduction in subjects with moderate hypertriglyceridaemia and at high cardiovascular risk. [2022]
Reduction in lipoprotein-associated apoC-III levels following volanesorsen therapy: phase 2 randomized trial results. [2021]
3.United Arab Emiratespubmed.ncbi.nlm.nih.gov
APOC-III Antisense Oligonucleotides: A New Option for the Treatment of Hypertriglyceridemia. [2019]
Real-world safety of icosapent ethyl: analysis based on spontaneous reports in FAERS database. [2023]
The role of antisense oligonucleotide therapy against apolipoprotein-CIII in hypertriglyceridemia. [2018]
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