Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

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.

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)

Keywords

Lipidemia, Type 2 Diabetes (T2DM), Metabolic Syndrome (MetS), Hyperlipidemias, Type 2 Diabetes Mellitus, Metabolic Syndrome, Ezetimibe, obicetrapib 10 mg + ezetimibe 10 mg FDC daily, Obicetrapib 10 mg, Obicetrapib/Ezetimibe, Obicetrapib, Open-Label Extension

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UC SanDiego Health
    La Jolla California 92037 United States
  • Scripps Health - Whittier Diabetes Institute
    La Jolla California 92037 United States
  • Western University of Health Sciences
    Pomona California 91766 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NewAmsterdam Pharma
ID
NCT07219602
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated