clinical trial · NCT07219602
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
NewAmsterdam Pharma·phase3·recruiting·n = 300
LipidemiaType 2 Diabetes (T2DM)Metabolic Syndrome (MetS)obicetrapib 10 mg + ezetimibe 10 mg FDC dailyObicetrapib 10 mgPlacebo
brief 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.
started
Dec 11, 2025
primary completion
Mar 1, 2028
completion
Jun 1, 2028
last updated
Mar 10, 2026
official title
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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol