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A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and Ezetimibe 10 mg Fixed Dose Combination Daily on Top of Maximally Tolerated Lipid-Modifying Therapy in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) and/or Atherosclerotic Cardiovascular Disease (ASCVD) or Multiple ASCVD Risk Factors

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Trial Profile

A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and Ezetimibe 10 mg Fixed Dose Combination Daily on Top of Maximally Tolerated Lipid-Modifying Therapy in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) and/or Atherosclerotic Cardiovascular Disease (ASCVD) or Multiple ASCVD Risk Factors

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 May 2025

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At a glance

  • Drugs Ezetimibe/obicetrapib (Primary) ; Ezetimibe; Obicetrapib
  • Indications Dyslipidaemias; Hyperlipoproteinaemia type IIa
  • Focus Registrational; Therapeutic Use
  • Acronyms TANDEM
  • Sponsors NewAmsterdam Pharma

Most Recent Events

  • 07 May 2025 According to a NewAmsterdam Pharma media release, data from the study were presented as oral presentations at the European Atherosclerosis Society Congress (EAS) 2025 and The Lancet (TANDEM).
  • 07 May 2025 Results presented in the NewAmsterdam Pharma Media Release
  • 10 Jan 2025 According to a NewAmsterdam Pharma media release, company plans to announce additional data from this study throughout 2025.NewAmsterdam expects to report additional data at an upcoming medical conference and to publish the data in a major medical journal.

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