RN0361 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 RN0361, an experimental therapy, to assess its safety and effectiveness for individuals with high triglycerides, a type of fat in the blood. The trial has two phases: it begins with healthy adults and then shifts focus to those with very high triglycerides. Ideal candidates have long struggled with triglyceride levels, particularly those over 300 mg/dL. Participants will receive either the RN0361 injection or a placebo to compare results. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.
Is there any evidence suggesting that RN0361 is likely to be safe for humans?
Research has shown that RN0361 was safe in earlier studies. Participants who took RN0361 experienced lower triglyceride levels (a type of fat in the blood) without major safety issues. No significant side effects were reported, indicating the treatment is generally well-tolerated. This study includes both healthy adults and those with high triglycerides to further assess the safety of RN0361. Current testing suggests it is relatively safe for people, but ongoing studies will provide more detailed information.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for high triglycerides, which often include lifestyle changes, statins, or fibrates, RN0361 is unique because it uses subcutaneous injections to deliver its effects. This method could potentially offer more direct and efficient control over triglyceride levels. Researchers are also excited about RN0361 because it might work through a novel mechanism that targets triglycerides differently than existing medications, offering hope for patients who haven't responded well to current options.
What evidence suggests that RN0361 might be an effective treatment for high triglycerides?
Research shows that RN0361, which participants in this trial may receive, may help lower triglyceride levels. This treatment, called siRNA, reduces a protein called ApoC3, which is linked to high triglyceride levels. In earlier studies, RN0361 significantly lowered both ApoC3 and triglycerides for up to six months. These early findings suggest that RN0361 could effectively manage high triglycerides.23567
Are You a Good Fit for This Trial?
This trial is for adults who are healthy or have high triglycerides, with specific blood fat levels. Participants must agree to study procedures and use effective contraception. They cannot donate sperm or eggs during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Treatment
Participants receive single ascending doses of RN0361 or placebo to evaluate safety, tolerability, and pharmacokinetics
Phase 2 Treatment
Participants receive a single dose of RN0361 or placebo to evaluate pharmacodynamic effects and immunogenicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RN0361
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ikaria Bioscience Pty Ltd
Lead Sponsor