RecruitingPhase 3NCT07219602

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)

Sponsor

NewAmsterdam Pharma

Enrollment

300 participants

Start Date

Dec 11, 2025

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes (T2DM)Lipidemia Metabolic Syndrome (MetS)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cholesterol-lowering medication (obicetrapib) — alone or combined with another drug called ezetimibe — in people who already take cholesterol medication but still have high cholesterol, and who also have type 2 diabetes or metabolic syndrome (a cluster of conditions that raise your risk of heart disease). **You may be eligible if...** - Your LDL ("bad") cholesterol is still high despite taking cholesterol-lowering medication - Your triglycerides (blood fats) are elevated but not extremely high - You have been diagnosed with type 2 diabetes OR have metabolic syndrome - You have been on a stable cholesterol medication regimen - Your kidneys are functioning at a basic minimum level **You may NOT be eligible if...** - You have severe heart failure (Class III or IV) or very poor heart pumping function - You were hospitalized for heart failure in the past 5 years - Your blood pressure is severely uncontrolled - You have a rare inherited cholesterol condition called homozygous familial hypercholesterolemia - Your blood sugar (HbA1c) is extremely poorly controlled (10% or higher) or fasting glucose is very high - You have active liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGobicetrapib 10 mg + ezetimibe 10 mg FDC daily

FDC

DRUGObicetrapib 10 mg

monotherapy

OTHERPlacebo

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07219602

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