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RECRUITINGPhase 3INTERVENTIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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

Locations (20)

Clinical Research Institute of Arizona
Sun City West, Arizona, United States
Scripps Health - Whittier Diabetes Institute
La Jolla, California, United States
UF Health Jackson
Jacksonville, Florida, United States
East Coast Institute of Research LLC
Jacksonville, Florida, United States
East Coast Institute of Research LLC
Lake City, Florida, United States
Floridian Clinical Research
Miami Lakes, Florida, United States
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, United States
MD Medical Research
Oxon Hill, Maryland, United States
Jefferson City Medical Group
Jefferson City, Missouri, United States
Montana Medical Research
Missoula, Montana, United States
Inspira Health - Internal Medicine Associates
Bridgeton, New Jersey, United States
Central New York Clinical Research
Manlius, New York, United States
Velocity Clinical Research
Durham, North Carolina, United States
Floridian Clinical Research
Greensboro, North Carolina, United States
Centricity Research dba Lucas Research
Morehead City, North Carolina, United States
Summit Research Group
Munroe Falls, Ohio, United States
Juno Research LLC - Medical Center
Houston, Texas, United States
Clinical Trials of Texas dba Flourish Research
San Antonio, Texas, United States
Burke Internal Medicine
Burke, Virginia, United States
Burke International Medicine DBA Manassas Clinical Research Center
Manassas, Virginia, United States