Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
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

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