Actively Recruiting
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
Led by NewAmsterdam Pharma · Updated on 2026-03-10
300
Participants Needed
20
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 of 70 mg/dL or higher
- Fasting triglycerides between 150 mg/dL and less than 400 mg/dL
- Diagnosis of Type 2 Diabetes Mellitus or metabolic syndrome with triglycerides 150 mg/dL or higher and at least 2 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...
- Current or past history of New York Heart Association class III or IV heart failure or left ventricular ejection fraction below 30%
- Hospitalization for heart failure within 5 years before screening
- Uncontrolled severe hypertension
- Diagnosis of homozygous familial hypercholesterolemia
- Hemoglobin A1c of 10.0% or higher or fasting glucose of 270 mg/dL or higher at screening
- Active liver disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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