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Obicetrapib alone or combined with ezetimibe added to usual cholesterol treatment for people with type 2 diabetes 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)

Phase 3 Interventional NewAmsterdam Pharma · NCT07219602

This trial will test whether adding obicetrapib alone or combined with ezetimibe to standard lipid-lowering therapy further lowers LDL-C and triglycerides in people with type 2 diabetes or metabolic syndrome.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorNewAmsterdam Pharma Industry-sponsored
Locations20 sites (Sun City West, Arizona and 19 other locations)
Trial IDNCT07219602 on ClinicalTrials.gov

What this trial studies

This double-blind, randomized, placebo-controlled Phase 3 study enrolls adults with type 2 diabetes and/or metabolic syndrome who have LDL-C ≥70 mg/dL and triglycerides 150–400 mg/dL despite guideline-recommended lipid-lowering therapy. Participants are randomized to obicetrapib 10 mg, obicetrapib 10 mg plus ezetimibe 10 mg fixed-dose combination, or placebo, given daily on top of their usual therapy. The study will track changes in lipid levels as primary efficacy measures and will monitor safety and tolerability throughout the treatment period. Study visits take place at clinical sites in Arizona, California, and Florida.

Who should consider this trial

Good fit: Adults with type 2 diabetes or metabolic syndrome who are on stable guideline-recommended lipid-lowering therapy and have fasting LDL-C ≥70 mg/dL with fasting triglycerides between 150 and 400 mg/dL meet the intended eligibility profile.

Not a fit: Patients with severe heart failure (NYHA class III/IV) or recent heart-failure hospitalization, very poorly controlled diabetes (HbA1c ≥10% or fasting glucose ≥270 mg/dL), homozygous familial hypercholesterolemia, active liver disease, or uncontrolled severe hypertension are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the regimen could provide additional LDL-C and triglyceride lowering for patients whose lipid levels remain elevated despite current standard therapy.

How similar studies have performed: Earlier-phase studies of obicetrapib and evidence from combining lipid-lowering agents like ezetimibe have shown meaningful LDL-C reductions, but CETP inhibitors have had mixed historical cardiovascular outcome results, so this phase 3 study aims to confirm efficacy and safety in this population.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* fasting serum LDL-C ≥ 70 mg/dL (≥1.81 mmol/L)
* Have fasting TG ≥150 mg/dL (≥1.7 mmol/L) and \<400 mg/dL (\<4.5 mmol/L)
* Know diagnosis of T2DM OR have metabolic syndrome defined as fasting TG ≥150 mg/dL (≥1.7mmol/L) and \<400 mg/dL (\<4.5 mmol/L) and at least 2 risk factors
* Are on stable guideline-recommended lipid-lowering therapy
* Estimated glomerular filtration rate ≥15 mL/min/1.73 m2

Exclusion Criteria:

* Have current or any previous history of New York Heart Association class III or IV heart failure or left ventricular ejection fraction \<30%
* Have been hospitalized for heart failure within 5 years prior to Screening
* Have uncontrolled severe hypertension
* Have a formal diagnosis of homozygous familial hypercholesterolemia
* HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening
* active liver disease

Where this trial is running

Sun City West, Arizona and 19 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions LipidemiaType 2 DiabetesMetabolic Syndrome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.