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ARO-DIMERPA for Mixed Hyperlipidemia

Recruiting at 16 trial locations
MM
Overseen ByMedical Monitor

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.12345

Why 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

Specific fasting TG, LDL-C, and non-high density lipoprotein cholesterol levels at Screening
Willing to follow diet counseling as per Investigator judgment based on local standard of care
Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later
See 1 more

Exclusion Criteria

I have been diagnosed with nephrotic syndrome.
My blood pressure is not well controlled.
I have a history of bleeding or blood clotting problems.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single or multiple ascending doses of ARO-DIMERPA or placebo

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: ARO-DIMERPAExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arrowhead Pharmaceuticals

Lead Sponsor

Trials
45
Recruited
6,200+

Citations

the 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)

Arrowhead 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 ...

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 ...

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 ...