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300 Participants NeededMy employer runs this trial

Obicetrapib + Ezetimibe for Diabetes

(RUBENS Trial)

Recruiting at 19 trial locations
GD
Overseen ByGagandeep Dhillon
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: NewAmsterdam Pharma
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

My kidney function is within the required range.
My LDL cholesterol level is 70 mg/dL or higher.
My fasting triglycerides are between 150 and 400 mg/dL.
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • Ezetimibe
  • Obicetrapib

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Open-Label ExtensionExperimental Treatment1 Intervention
Group II: Obicetrapib/EzetimibeExperimental Treatment1 Intervention
Group III: ObicetrapibExperimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NewAmsterdam Pharma

Lead Sponsor

Trials
17
Recruited
13,900+

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