This study will evaluate the efficacy and safety of plozasiran in approximately 288 adult participants with severe hypertriglyceridemia (SHTG) and history of at least two prior acute pancreatitis (AP) events not attributed to other etiologies, with at least one occurring within the last 12 months prior to screening. Eligible participants will be randomly assigned in a double-blind manner to either receive plozasiran 25 mg by subcutaneous (SC) injection every three months (Q3M) or matching placebo. Enrolled participants will be counseled to remain on the specified low-fat diet and background medications throughout the study. Following completion of the double-blind treatment period, or if the participant has a positively adjudicated AP event (whichever occurs first), participants will transition to the 12-month Open-Label Extension (OLE) treatment period receiving plozasiran 25 mg by SC injection Q3M.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
288
ARO-APOC3 injection
sterile normal saline (0.9% NaCl)
Research Site
Los Angeles, California, United States
RECRUITINGClinical Research Site 4
Santa Clarita, California, United States
RECRUITINGClinical Research Site 6
Springfield, Illinois, United States
RECRUITINGResearch Site
Indianapolis, Indiana, United States
Time to First Occurrence of Positively Adjudicated AP Event (Event Occurring More Than 10 Days After First Dose of Study Drug)
Time frame: Randomization up to end of Double Blind Treatment Period compared to placebo (Approximate Maximum 50 Months)]
Percent Change from Baseline in Fasting Serum Triglyceride (TG) Levels
Time frame: Baseline up to end of Double Blind Treatment Period compared to placebo (Approximate Maximum 50 Months)
Proportion of Participants Who Achieve Average Fasting TG Levels of < 880 mg/dL (10 mmol/L)
Time frame: From Month 3 up to end of Double Blind Treatment Period compared to placebo (Approximate Maximum 50 Months)
Proportion of Participants Who Achieve Fasting TG Levels of < 500 mg/dL (5.65 mmol/L)
Time frame: From Month 3 up to end of Double Blind Treatment Period compared to placebo (Approximate Maximum 50 Months)
Time to First Occurrence of Major Abdominal Pain Event (Event Occurring More Than 10 Days After the First Dose of Study Drug).
Time frame: Randomization up to end of Double Blind Treatment Period compared to placebo (Approximate Maximum 50 Months)
Change from Baseline in Patient-Reported Productivity and Activity Impairment as Assessed by the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) Score
Time frame: Baseline up to end of Double Blind Treatment Period Study compared to placebo (Approximate Maximum 50 Months)
Change from Baseline in Patient-Reported Health Status as Assessed by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Score
Time frame: Baseline up to end of Double Blind Treatment Period compared to placebo (Approximate Maximum 50 Months)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) compared to placebo
Time frame: From first dose of study drug up to Study Completion (Approximate Maximum 62 Months)
Rate of Occurrence of Adjudicated Major Cardiovascular Events (MACE)
Time frame: From first dose of study drug up to Study Completion (Approximate Maximum 62 Months)
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Research Site
Kansas City, Kansas, United States
RECRUITINGResearch Site
St Louis, Missouri, United States
RECRUITINGClinical Research Site 5
North Platte, Nebraska, United States
RECRUITINGClinical Research Site 3
Greensboro, North Carolina, United States
RECRUITINGResearch Site
Wilmington, North Carolina, United States
RECRUITINGClinical Research Site 7
Philadelphia, Pennsylvania, United States
RECRUITING...and 51 more locations