Study of ARO-APOC3 (Plozasiran) in Adults With Familial Chylomicronemia Syndrome (FCS)

NCT05089084 · PALISADE Phase 3Completed

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Lead sponsor: Arrowhead Pharmaceuticals (Industry)
Enrollment: 75 (actual)
Start date: 14 Dec 2021
Primary completion: 29 Apr 2024 (actual)
Study completion: 21 Apr 2026
Last update posted: 5 Jun 2026

Design

Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel
Masking: Quadruple
Arms: 4

Interventions

Plozasiran Drug
Placebo Drug

Conditions and primary outcome

Familial Chylomicronemia

Primary outcome

Percent Change From Baseline at Month 10 in Fasting Triglycerides (TG) (Baseline, Month 10)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT05089084 (opens in a new tab)· Licence: public-domain

First posted 4 Feb 2026 · Last update posted 5 Jun 2026 · Imported 26 Oct 2026 from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

Percent Change From Baseline at Month 10 in Fasting Triglycerides (TG)
Time frame
Baseline, Month 10
Measure
Median
Unit
percentage change
- Placebo (Pooled) vs ARO-APOC3 (Plozasiran) 25 mgSuperiority
  Estimate
  -58.7Median Difference (Final Values)
  95% CI, two-sided
  -89.6 to -27.9
  p-value
  < 0.0001
  Method
  Wilcoxon rank-sum test
- Placebo (Pooled) vs ARO-APOC3 (Plozasiran) 25 mgSuperiority
  Estimate
  Not given
  CI
  Not given
  p-value
  <0.0001
  Method
  Holm method
- Placebo (Pooled) vs ARO-APOC3 (Plozasiran) 50 mgSuperiority
  Estimate
  -52.5Median Difference (Final Values)
  95% CI, two-sided
  -83.1 to -21.9
  p-value
  0.0002
  Method
  Wilcoxon rank-sum test
- Placebo (Pooled) vs ARO-APOC3 (Plozasiran) 50 mgSuperiority
  Estimate
  Not given
  CI
  Not given
  p-value
  0.0002
  Method
  Holm method

Serious adverse events

Time frame: Screening through Month 12 (Randomized Period)

Participants with serious adverse events per group for PALISADE, as posted
Group	Affected	At risk
Placebo (Pooled)	7	25
ARO-APOC3 (Plozasiran) 25 mg	5	26
ARO-APOC3 (Plozasiran) 50 mg	2	24

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

2 on PubMed

Clinical Trial: Plozasiran Prevents Recurrent Pancreatitis in Adults With Very Severe Hypertriglyceridemia-Results of a Post Hoc Analysis of the Phase 3 PALISADE Study.
Alimentary pharmacology & therapeutics · 2026 May
PubMed 41923352 (opens in a new tab)DOI 10.1111/apt.70623 (opens in a new tab)
Plozasiran for Managing Persistent Chylomicronemia and Pancreatitis Risk.
The New England journal of medicine · 2025 Jan 9
PubMed 39225259 (opens in a new tab)DOI 10.1056/NEJMoa2409368 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Plozasiran

Source

NCT05089084 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read 25 Oct 2026

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.