ARO-DIMERPA for Mixed Hyperlipidemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ARO-DIMERPA for individuals with mixed hyperlipidemia, a condition characterized by high levels of bad cholesterol (LDL-C) and triglycerides in the blood. The main goals are to assess the treatment's safety, its effects on the body, and its ability to lower cholesterol levels. Participants will receive either varying doses of the treatment or a placebo, which is a harmless substance with no effect on the body. Suitable candidates have high cholesterol or triglycerides and are willing to follow dietary advice. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to be among the first to benefit from this potential new therapy.
Is there any evidence suggesting that ARO-DIMERPA is likely to be safe for humans?
Research has shown that ARO-DIMERPA is being tested for safety in people with mixed hyperlipidemia, which involves high levels of fats in the blood. Although detailed safety information from past studies isn't available, the treatment has advanced to early human trials, suggesting it has shown promise and was generally well-tolerated in lab settings or earlier tests.
ARO-DIMERPA targets specific genes related to cholesterol and fat levels in the blood. While specific side effects are not listed in the available information, the absence of major concerns in early trials is encouraging. As with any new treatment, ongoing studies will closely monitor participants' responses.12345Why do researchers think this study treatment might be promising for hyperlipidemia?
Unlike the standard treatments for mixed hyperlipidemia, which often include statins and fibrates that work by reducing cholesterol production or increasing its removal from the blood, ARO-DIMERPA takes a novel approach. This treatment uses RNA interference to target and reduce the production of specific proteins involved in lipid metabolism. Researchers are excited because this method has the potential to more precisely lower lipid levels with fewer side effects. Additionally, ARO-DIMERPA may offer a more flexible dosing regimen, potentially improving patient adherence and outcomes.
What evidence suggests that ARO-DIMERPA might be an effective treatment for mixed hyperlipidemia?
Research has shown that ARO-DIMERPA, which participants in this trial may receive, may help lower cholesterol and triglycerides, fats found in the blood. In studies, it reduced triglycerides by 50%, total cholesterol by 30%, and LDL cholesterol (often called "bad" cholesterol) by 50%. Lowering these fats is important because high levels can lead to heart disease. The treatment targets two genes that affect cholesterol and fat levels. This dual action makes it a potentially effective option for people with mixed hyperlipidemia, a condition involving high levels of different blood fats.14567
Are You a Good Fit for This Trial?
This trial is for adults with mixed hyperlipidemia (high cholesterol and triglycerides) who meet specific blood fat levels. Participants must be willing to follow diet advice and use effective birth control during the study and for 90 days after.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single or multiple ascending doses of ARO-DIMERPA or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ARO-DIMERPA
Trial Overview
The study tests a new drug called ARO-DIMERPA, given as single or multiple doses, compared to a placebo. It looks at safety, how the body processes the drug, and its effects on cholesterol and triglyceride levels.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
ARO-DIMERPA in single or multiple ascending doses
Placebo (normal saline, 0.9%) in single or multiple matching doses
Find a Clinic Near You
Who Is Running the Clinical Trial?
Arrowhead Pharmaceuticals
Lead Sponsor
Citations
1.
ir.arrowheadpharma.com
ir.arrowheadpharma.com/news-releases/news-release-details/arrowhead-pharmaceuticals-initiates-phase-12a-study-aro-dimer-pathe First Dual Functional RNAi Therapeutic ...
We see ARO-DIMER-PA as having the potential to reduce the risk of ASCVD for people living with mixed hyperlipidemia, and we are excited to see ...
Development of a dual functional RNAi therapeutic, ARO ...
ARO-DIMER-PA at 6 mg/kg resulted in durable decreases of triglycerides (-50%), total cholesterol (-30%) and LDL cholesterol (-50%).
Study of ARO-DIMERPA in Adult Participants With Mixed ...
Study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), and effects on low-density lipoprotein cholesterol (LDL-C)
4.
arrowheadpharma.com
arrowheadpharma.com/en-us/newsroom/arrowhead-pharmaceuticals-initiates-phase-12a-study-aro-dimer-paArrowhead Pharmaceuticals Initiates Phase 1/2a Study of ...
We see ARO-DIMER-PA as having the potential to reduce the risk of ASCVD for people living with mixed hyperlipidemia, and we are excited to see ...
ARO-DIMER-PA - Drug Targets, Indications, Patents
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of ARO-DIMERPA in Adult Subjects With Mixed Hyperlipidemia 100 Clinical ...
6.
clinicaltrialsarena.com
clinicaltrialsarena.com/news/arrowhead-begins-dosing-trial-hyperlipidaemia/Arrowhead begins dosing in Phase I/IIa trial for ...
“We see ARO-DIMER-PA as having the potential to reduce the risk of ASCVD for people living with mixed hyperlipidaemia, and we are excited to see ...
7.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT07223658/study-of-aro-dimerpa-in-adult-participants-with-mixed-hyperlipidemiaStudy of ARO-DIMERPA in Adult Participants With Mixed ...
Study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), and effects on low-density lipoprotein ...
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