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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 or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome (RUBENS Trial)

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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 or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome (RUBENS Trial)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 28 Jan 2026

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At a glance

  • Drugs Ezetimibe/obicetrapib (Primary) ; Obicetrapib (Primary)
  • Indications Metabolic syndrome; Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms RUBENS
  • Sponsors NewAmsterdam Pharma

Most Recent Events

  • 09 Jan 2026 Status changed from not yet recruiting to recruiting.
  • 09 Jan 2026 According NewAmsterdam Pharma media release, First patient enrolled in RUBENS Phase 3 trial of obicetrapib and obicetrapib/ezetimibe fixed dose combo (FDC) in patients with metabolic syndrome in December and expect topline results from the trial by the end of 2026.
  • 05 Nov 2025 According NewAmsterdam Pharma media release, trial is expected to initiate in the fourth quarter of 2025.

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