ARO-APOC3 for Chylomicronemia Syndrome
(PALISADE Trial)

Recruiting in Palo Alto (17 mi)

+62 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Arrowhead Pharmaceuticals

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called plozasiran in adults with a rare genetic disorder that causes very high blood fat levels. The drug aims to lower these fat levels by reducing a specific protein in the blood.

Research Team

Eligibility Criteria

Adults with familial chylomicronemia syndrome (FCS) who are willing to follow dietary advice and have very high fasting triglyceride levels. They must use effective contraception, not be pregnant or breastfeeding, and cannot have had major surgery or uncontrolled conditions like hypertension recently.

Inclusion Criteria

I am using or willing to use effective birth control and will not donate sperm while on the study and for 24 weeks after.

My fasting triglycerides are very high despite taking standard treatments.

I have been diagnosed with Familial Chylomicronemia Syndrome (FCS).

See 3 more

Exclusion Criteria

I am currently on HIV medication.

I was diagnosed with diabetes recently or my HbA1c level is 9.0% or higher.

I have not had pancreatitis in the last 3 months.

See 6 more

Treatment Details

Interventions

ARO-APOC3 (Antisense Oligonucleotide)
Placebo (Other)

Trial OverviewThe trial is testing ARO-APOC3 against a placebo in adults with FCS. Participants will receive either the drug or placebo through subcutaneous injections over a period, followed by an open-label extension where all get ARO-APOC3.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ARO-APOC3 (plozasiran)Experimental Treatment1 Intervention

4 doses of plozasiran by subcutaneous (sc) injection (randomized period) 8 doses of plozasiran by sc injection (open-label period)

Group II: PlaceboPlacebo Group1 Intervention

calculated volume to match active treatment by sc injection (randomized period)