Clinical Trial

A Study to Evaluate the Effect of Obicetrapib/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

Study acronym: RUBENS
Recruiting Phase 3
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Summary
This study will be a placebo-controlled, double-blind, randomized, Phase 3 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both as a fixed-dose combination (FDC) with ezetimibe 10 mg and as monotherapy, on top of guideline-recommended lipid-lowering therapy in patients with metabolic syndrome and/or Type 2 Diabetes Mellitus.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-10-20; most recent amendment 2026-03-06.
Status change: Not Yet Recruiting → Recruiting 2026-03-06
Trial Details
NCT Number NCT07219602
Lead Sponsor NewAmsterdam Pharma
Conditions Lipidemia, Type 2 Diabetes (T2DM), Metabolic Syndrome (MetS)
Enrollment 300 participants
Start Date 2025-12-11
Primary Completion 2028-03 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-03-10