Study of ARO-DIMERPA in Adult Participants With Mixed Hyperlipidemia

Arrowhead Pharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Hyperlipidemia; Mixed

Treatments: Drug: Placebo; Drug: ARO-DIMERPA

Study type: Interventional

Funder types: Industry

Identifiers

NCT07223658

ARODIMERPA-1001

Details and patient eligibility

About

Study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD), and effects on low-density lipoprotein cholesterol (LDL-C) and triglycerides (TGs) of single-dose ARO-DIMERPA and multiple doses of ARO-DIMERPA in adult participants with mixed hyperlipidemia.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing to follow diet counseling as per Investigator judgment based on local standard of care
• Specific fasting TG, LDL-C, and non-high density lipoprotein cholesterol levels at Screening
• 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; participants must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study drug whichever is later

Exclusion criteria

• Current use or use within last 365 days or within 5-half-lives before Day 1 based on plasma PK, whichever is longer, of any hepatocyte-targeted siRNA
• Current use or use within last 90 days or within 5-half-lives before Day 1 based on plasma PK, whichever is longer, of any antisense oligonucleotide therapy
• Current use or use within last 60 days from Day 1 of any PCSK9 inhibitor monoclonal antibodies (eg, evolocumab or alirocumab)
• Uncontrolled hypertension
• History of bleeding diathesis or coagulopathy
• Current diagnosis of nephrotic syndrome

Note: Additional inclusion/exclusion criteria may apply per protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups, including a placebo group

ARO-DIMERPA

Experimental group

Description:

ARO-DIMERPA in single or multiple ascending doses

Treatment:

Drug: ARO-DIMERPA

Placebo

Placebo Comparator group

Description:

Placebo (normal saline, 0.9%) in single or multiple matching doses

Treatment:

Drug: Placebo