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Phase 1/2a, Double-blind, Placebo-controlled, Single and Multiple Dose-escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of ARO-DIMERPA in Adult Subjects With Mixed Hyperlipidemia

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
New Zealand
Research Site 1
RECRUITING
Christchurch
Contact Information
Primary
Medical Monitor
ARODIMERPA-1001@arrowheadpharma.com
626-304-3400
Time Frame
Start Date: 2025-12-22
Estimated Completion Date: 2027-07
Participants
Target number of participants: 78
Treatments
Experimental: ARO-DIMERPA
ARO-DIMERPA in single or multiple ascending doses
Placebo_comparator: Placebo
Placebo (normal saline, 0.9%) in single or multiple matching doses
Related Therapeutic Areas
Sponsors
Leads: Arrowhead Pharmaceuticals

This content was sourced from clinicaltrials.gov