Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults with Severe Hypertriglyceridemia (SHASTA-4 Study)

Conditions

Severe hypertriglyceridemia (SHTG)

Brief summary

Percent change in fasting serum TG levels from baseline to Month 12 (V10 and V11) compared to placebo

Detailed description

Percent change in fasting serum TG levels from baseline to Month 10 (V8 and V9) compared to placebo, Proportion of subjects who achieve fasting TG levels of <500 mg/dL (<5.65 mmol/L) at Month 12 (V10 and V11) compared to placebo, Proportion of subjects who achieve fasting TG levels of <150 mg/dL (<1.69 mmol/L) at Month 12 (V10 and V11) compared to placebo, Percent change in remnant cholesterol (VLDL-C) from baseline to Month 12 (V11) compared to placebo, Percent change in non-HDL-C from baseline to Month 12 (V11) compared to placebo, Adjudicated abdominal clinical event rate including ER visits or hospitalizations for abdominal pain attributed to hypertriglyceridemia and events of documented pancreatitis during the treatment period compared to placebo at Month 12 (V11)

Related papers

No related papers found yet.

Interventions

DRUGPlozasiran Injection Placebo

DRUGARO-APOC3 PFS

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change in fasting serum TG levels from baseline to Month 12 (V10 and V11) compared to placebo	—

Secondary

Measure	Time frame
Percent change in fasting serum TG levels from baseline to Month 10 (V8 and V9) compared to placebo, Proportion of subjects who achieve fasting TG levels of <500 mg/dL (<5.65 mmol/L) at Month 12 (V10 and V11) compared to placebo, Proportion of subjects who achieve fasting TG levels of <150 mg/dL (<1.69 mmol/L) at Month 12 (V10 and V11) compared to placebo, Percent change in remnant cholesterol (VLDL-C) from baseline to Month 12 (V11) compared to placebo, Percent change in non-HDL-C from baseline to Month 12 (V11) compared to placebo, Adjudicated abdominal clinical event rate including ER visits or hospitalizations for abdominal pain attributed to hypertriglyceridemia and events of documented pancreatitis during the treatment period compared to placebo at Month 12 (V11)	—

Measure

Time frame

Percent change in fasting serum TG levels from baseline to Month 10 (V8 and V9) compared to placebo, Proportion of subjects who achieve fasting TG levels of <500 mg/dL (<5.65 mmol/L) at Month 12 (V10 and V11) compared to placebo, Proportion of subjects who achieve fasting TG levels of <150 mg/dL (<1.69 mmol/L) at Month 12 (V10 and V11) compared to placebo, Percent change in remnant cholesterol (VLDL-C) from baseline to Month 12 (V11) compared to placebo, Percent change in non-HDL-C from baseline to Month 12 (V11) compared to placebo, Adjudicated abdominal clinical event rate including ER visits or hospitalizations for abdominal pain attributed to hypertriglyceridemia and events of documented pancreatitis during the treatment period compared to placebo at Month 12 (V11)

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Countries

Bulgaria, Czechia, France, Germany, Hungary, Latvia, Lithuania, Poland, Slovakia, Spain

Outcome results

None listed