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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
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
2026-03-10
Healthy Volunteers
No
Interventions
obicetrapib 10 mg + ezetimibe 10 mg FDC daily
FDC
Obicetrapib 10 mg
monotherapy
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