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Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Severe Hypertriglyceridemia

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Trial Profile

Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Severe Hypertriglyceridemia

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Dec 2025

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At a glance

  • Drugs Plozasiran (Primary)
  • Indications Hypertriglyceridaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms SHASTA-3
  • Sponsors Arrowhead Pharmaceuticals

Most Recent Events

  • 02 Dec 2025 According to an Arrowhead Pharmaceuticals media release, the company is on schedule to complete the SHASTA-3, SHASTA-4, and MUIR-3 Phase 3 clinical studies of plozasiran in mid-2026 and intends to submit a supplemental New Drug Application (sNDA) to the FDA by year-end 2026. The company also plans to seek regulatory approval with additional global regulatory authorities thereafter.
  • 02 Dec 2025 According to an Arrowhead Pharmaceuticals media release, the company announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to plozasiran as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (SHTG).
  • 01 Dec 2025 According to an Arrowhead Pharmaceuticals media release, data from this study will be presented at World Congress of Insulin Resistance, Diabetes and Cardiovascular Disease (WCIRDC) on December 4 to 6, 2025

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