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

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: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: NewAmsterdam Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lipidemia
• Type 2 Diabetes (T2DM)
• Metabolic Syndrome (MetS)

Interventions

Type	Name	Description
DRUG	obicetrapib 10 mg + ezetimibe 10 mg FDC daily	FDC
DRUG	Obicetrapib 10 mg	monotherapy
OTHER	Placebo	placebo on top of guideline-recommended lipid modifying therapy

Timeline

• Start date: 2025-12-11
• Primary completion: 2028-03-01
• Completion: 2028-06-01
• First posted: 2025-10-22
• Last updated: 2026-03-10

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study