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ACTIVE NOT RECRUITING
NCT07219602
PHASE3

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

Sponsor: NewAmsterdam Pharma

View on ClinicalTrials.gov

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-12-11

Completion Date

2028-06

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

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 (55)

Clinical Research Institute of Arizona

Sun City West, Arizona, United States

Scripps Health - Whittier Diabetes Institute

La Jolla, California, United States

UC SanDiego Health

La Jolla, California, United States

Western University of Health Sciences

Pomona, 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

K2 Medical Research

Maitland, Florida, United States

Floridian Clinical Research

Miami Lakes, Florida, United States

Cardiovascular Center of Sarasote Foundation for Research and Education

Sarasota, Florida, United States

High Desert Heart

Meridian, Idaho, United States

Endeavour Health

Skokie, Illinois, United States

Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

Louisville, Kentucky, United States

Eastern Maine Medical Center

Bangor, Maine, 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

Duke University Medical Center

Durham, North Carolina, United States

Velocity Clinical Research

Durham, North Carolina, United States

PharmQuest Life Sciences, LLC

Greensboro, North Carolina, United States

Centricity Research dba Lucas Research

Morehead City, North Carolina, United States

Summit Research Group

Munroe Falls, Ohio, United States

Diabetes & Glandular Disease Clinic, P.A.

Kingsport, Tennessee, United States

Baylor College of Medicine - Center for Cardiometabolic Disease Prevention (The Center for Cardiovascular Disease Prevention)

Houston, Texas, United States

Juno Research LLC - Medical Center

Houston, Texas, United States

PlanIt Research, PLLC

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

Universal Research Group

Tacoma, Washington, United States

Dien Servis s.r.o.

Humpolec, Vysocina, Czechia

DOCTOR MN s.r.o

Čáslav, Czechia

MUDr. Alena Váchová

České Budějovice, Czechia

MEDIKA Hradec Králové, s.r.o.

Hradec Králové, Czechia

Interni diabetologicka ambulance (Pratia)

Jílové u Prahy, Czechia

Diabetologie - Dr. Tomas Edelsberger

Krnov, Czechia

Pratia Pardubice a.s. (Pratia)

Pardubice, Czechia

Dieko s.r.o

Pilsen, Czechia

Nemocnice Na Františku

Prague, Czechia

Institut klinicke a experimentalni mediciny

Prague, Czechia

Fakultni Nemocnice (FN) v Motole (Motol University Hospital)

Prague, Czechia

Bethesda Diabetes Research Center

Hoogeveen, Drenthe, Netherlands

Rijnstate Ziekenhuis

Arnhem, Gelderland, Netherlands

Noordwest Ziekenhuisgroep - Alkmaar

Alkmaar, North Holland, Netherlands

Deventer Ziekenhuis

Deventer, Overijssel, Netherlands

Albert Schweitzer Ziekenhuis

Zwijndrecht, South Holland, Netherlands

Human-Care, s.r.o.

Košice, Košice Region, Slovakia

Pavol Jozef Šafárik University

Košice, Košice Region, Slovakia

Funkystuff s.r.o.

Nové Zámky, Nitra Region, Slovakia

MUDr. Žáková s.r.o.

Trenčín, Trenčín Region, Slovakia

DIA-GNOSIS, s.r.o.

Piešťany, Trnava Region, Slovakia

JAL s.r.o.

Trnava, Trnava Region, Slovakia

Nemocnicna a.s

Malacky, Slovakia