A PHASE 3 OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF PLOZASIRAN IN ADULTS WITH HYPERTRIGLYCERIDEMIA (SHASTA-10 STUDY)

Conditions

Hypertriglyceridemia (HTG)

Brief summary

Subject incidence of treatment-emergent adverse events (TEAEs)

Detailed description

Change and percent change from baseline over time in fasting TG levels, Change and percent change from baseline over time in APOC3, Change and percent change from baseline over time in remnant cholesterol, Change and percent change from baseline over time in fasting non-HDL-C, Change and percent change from baseline over time in fasting HDL-C, Change and percent change from baseline over time in fasting total Apo B, Change and percent change from baseline over time in fasting LDL-C using ultracentrifugation, Change from baseline over time in hemoglobin A1c (HbA1c), Subject incidence of emergent apheresis, Adjudicated MACE event rates during the treatment period, Incidence and titers of ADA to plozasiran in those receiving plozasiran over time

Related papers

No related papers found yet.

Interventions

DRUGARO-APOC3 PFS

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Subject incidence of treatment-emergent adverse events (TEAEs)	—

Secondary

Measure	Time frame
Change and percent change from baseline over time in fasting TG levels, Change and percent change from baseline over time in APOC3, Change and percent change from baseline over time in remnant cholesterol, Change and percent change from baseline over time in fasting non-HDL-C, Change and percent change from baseline over time in fasting HDL-C, Change and percent change from baseline over time in fasting total Apo B, Change and percent change from baseline over time in fasting LDL-C using ultracentrifugation, Change from baseline over time in hemoglobin A1c (HbA1c), Subject incidence of emergent apheresis, Adjudicated MACE event rates during the treatment period, Incidence and titers of ADA to plozasiran in those receiving plozasiran over time	—

Measure

Time frame

Change and percent change from baseline over time in fasting TG levels, Change and percent change from baseline over time in APOC3, Change and percent change from baseline over time in remnant cholesterol, Change and percent change from baseline over time in fasting non-HDL-C, Change and percent change from baseline over time in fasting HDL-C, Change and percent change from baseline over time in fasting total Apo B, Change and percent change from baseline over time in fasting LDL-C using ultracentrifugation, Change from baseline over time in hemoglobin A1c (HbA1c), Subject incidence of emergent apheresis, Adjudicated MACE event rates during the treatment period, Incidence and titers of ADA to plozasiran in those receiving plozasiran over time

—

Countries

Belgium, Bulgaria, Croatia, Czechia, France, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Romania, Slovakia, Spain

Outcome results

None listed