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 all (17) locations...
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
Australia
Research Site 7
RECRUITING
Charlestown
Research Site 11
RECRUITING
Clayton
Research Site 8
RECRUITING
East Melbourne
Research Site 4
RECRUITING
Melbourne
Research Site 5
RECRUITING
Morayfield
Research Site 9
RECRUITING
Perth
Canada
Research Site 10
RECRUITING
Calgary
Research Site 17
RECRUITING
Chicoutimi
Research Site 16
RECRUITING
Toronto
Georgia
Research Site 13
RECRUITING
Tbilisi
Research Site 14
RECRUITING
Tbilisi
Research Site 15
RECRUITING
Tbilisi
New Zealand
Research Site 2
RECRUITING
Auckland
Research Site 3
RECRUITING
Auckland
Research Site 1
RECRUITING
Christchurch
Research Site 6
RECRUITING
Grafton
Research Site 12
RECRUITING
Wellington
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