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

Conditions

• Familial Chylomicronemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Plozasiran — DRUG
  ARO-APOC3 subcutaneous (SC) injection
• Placebo — DRUG
  sterile normal saline (0.9% NaCl) SC injection

Study Details

The purpose of AROAPOC3-3001 is to evaluate the efficacy and safety of ARO-APOC3 (plozasiran) in adult participants with familial chylomicronemia syndrome (FCS). Participants who have met all eligibility criteria will be randomized to receive 4 doses of plozasiran or matching placebo administered subcutaneously. Participants who complete the randomized period will continue in a 2-year open-label extension period where all participants will receive plozasiran.

Key Dates

Start date

Dec 14, 2021

Status verified

May 2026

Primary completion

Apr 29, 2024

Completion

Apr 21, 2026

Study Design

Enrollment

75 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ARO-APOC3 (Plozasiran) 25 mg
  Randomized Period: plozasiran 25 mg Q3M for a total of 4 doses. Open-label Period (Parts A and B): plozasiran 25 mg Q3M for a total of 8 doses.
• Placebo Comparator: Placebo for ARO-APOC3 (Plozasiran) 25 mg
  Randomized Period: volume-matched placebo every 3 months (Q3M) for a total of 4 doses. Open-label Period (Parts A and B): plozasiran 25 mg Q3M for a total of 8 doses.
• Experimental: ARO-APOC3 (Plozasiran) 50 mg
  Randomized Period: plozasiran 25 mg Q3M for a total of 4 doses. Open-label Period: plozasiran 50 mg (Part A), then 25 mg (Part B) Q3M for a total of 8 doses.
• Placebo Comparator: Placebo for ARO-APOC3 (Plozasiran) 50 mg
  Randomized Period: volume-matched placebo every 3 months (Q3M) for a total of 4 doses. Open-label Period: plozasiran 50 mg (Part A), then 25 mg (Part B) Q3M for a total of 8 doses.

Primary Outcome Measure

Percent Change From Baseline at Month 10 in Fasting Triglycerides (TG) [ Time Frame: Baseline, Month 10 ]

Locations (9)

Related coverage on Hipa.ai

• Plozasiran Phase 3 Trial for FCS Shows Significant Triglyceride Reduction
  Plozasiran · Feb 4, 2026 · ClinicalTrials.gov
• Plozasiran Phase 3 FCS Trial: Fasting Triglycerides Reduced by Over 80%
  Plozasiran · Apr 29, 2024 · ClinicalTrials.gov

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