Actively Recruiting
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)
Led by NewAmsterdam Pharma · Updated on 2026-03-10
300
Participants Needed
20
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of obicetrapib 10 mg, alone and combined with ezetimibe 10 mg, alongside standard lipid-lowering treatment in adults with metabolic syndrome and/or Type 2 Diabetes Mellitus. This Phase 3, randomized, placebo-controlled, double-blind study aims to assess how these treatments affect cholesterol levels and their safety and tolerability. Participants will be assigned to one of three groups: a fixed-dose combination daily of obicetrapib 10 mg plus ezetimibe 10 mg, obicetrapib 10 mg alone daily, or a placebo with standard lipid-lowering therapy. After the initial treatment period, there is an open-label extension where all may receive the combination of obicetrapib and ezetimibe. The study treatments are taken daily. During the study, participants will have their cholesterol and lipid levels measured at the start and after 84 days to evaluate changes in LDL-C and other lipid markers. The research team will monitor safety, tolerability, and other blood markers related to cholesterol. The entire study period includes initial treatment and an extension phase, with ongoing evaluations to understand how the treatments influence lipid levels and patient health.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fasting serum LDL cholesterol level of 70 mg/dL (1.81 mmol/L) or higher
- Fasting triglyceride levels between 150 mg/dL (1.7 mmol/L) and less than 400 mg/dL (4.5 mmol/L)
- Diagnosed with Type 2 Diabetes Mellitus or metabolic syndrome defined by triglyceride levels and at least two risk factors
- On stable guideline-recommended lipid-lowering therapy
- Estimated glomerular filtration rate of 15 mL/min/1.73 m2 or higher
You will not qualify if you...
- History of severe heart failure (New York Heart Association class III or IV) or left ventricular ejection fraction less than 30%
- Hospitalization for heart failure within 5 years prior to screening
- Uncontrolled severe high blood pressure
- Diagnosis of homozygous familial hypercholesterolemia
- HbA1c level of 10.0% or higher, or fasting glucose of 270 mg/dL (15.0 mmol/L) or higher at screening
- Active liver disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 84 days
Participants receive daily doses of either the drug combination, monotherapy, or placebo on top of their current lipid-lowering therapy.
Multiple visits during treatment period
Trial Site Locations
Total: 20 locations
1
Clinical Research Institute of Arizona
Sun City West, Arizona, United States, 85375
Actively Recruiting
2
Scripps Health - Whittier Diabetes Institute
La Jolla, California, United States, 92037
Actively Recruiting
3
UF Health Jackson
Jacksonville, Florida, United States, 32209
Actively Recruiting
4
East Coast Institute of Research LLC
Jacksonville, Florida, United States, 32216
Actively Recruiting
5
East Coast Institute of Research LLC
Lake City, Florida, United States, 32055
Actively Recruiting
6
Floridian Clinical Research
Miami Lakes, Florida, United States, 33016
Actively Recruiting
7
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, United States, 40213
Actively Recruiting
8
MD Medical Research
Oxon Hill, Maryland, United States, 20745
Actively Recruiting
9
Jefferson City Medical Group
Jefferson City, Missouri, United States, 65109
Actively Recruiting
10
Montana Medical Research
Missoula, Montana, United States, 59808
Actively Recruiting
11
Inspira Health - Internal Medicine Associates
Bridgeton, New Jersey, United States, 08302
Actively Recruiting
12
Central New York Clinical Research
Manlius, New York, United States, 13104
Actively Recruiting
13
Velocity Clinical Research
Durham, North Carolina, United States, 27710
Actively Recruiting
14
Floridian Clinical Research
Greensboro, North Carolina, United States, 27408
Actively Recruiting
15
Centricity Research dba Lucas Research
Morehead City, North Carolina, United States, 28557
Actively Recruiting
16
Summit Research Group
Munroe Falls, Ohio, United States, 44262
Actively Recruiting
17
Juno Research LLC - Medical Center
Houston, Texas, United States, 77054
Actively Recruiting
18
Clinical Trials of Texas dba Flourish Research
San Antonio, Texas, United States, 78229
Actively Recruiting
19
Burke Internal Medicine
Burke, Virginia, United States, 22015-2234
Actively Recruiting
20
Burke International Medicine DBA Manassas Clinical Research Center
Manassas, Virginia, United States, 20110
Actively Recruiting
Research Team
G
Gagandeep Dhillon
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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