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
Recruiting · NCT07219602 · Interventional (participants receive a specific treatment) · Lead sponsor: NewAmsterdam Pharma
View the official record on ClinicalTrials.gov →Interventions studied
Obicetrapib 10 mgPlaceboobicetrapib 10 mg + ezetimibe 10 mg FDC daily
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- fasting serum LDL-C ≥ 70 mg/dL (≥1.81 mmol/L)
- Have fasting TG ≥150 mg/dL (≥1.7 mmol/L) and \<400 mg/dL (\<4.5 mmol/L)
- Know diagnosis of T2DM OR have metabolic syndrome defined as fasting TG ≥150 mg/dL (≥1.7mmol/L) and \<400 mg/dL (\<4.5 mmol/L) and at least 2 risk factors
- Are on stable guideline-recommended lipid-lowering therapy
- Estimated glomerular filtration rate ≥15 mL/min/1.73 m2
Exclusion criteria
- Have current or any previous history of New York Heart Association class III or IV heart failure or left ventricular ejection fraction \<30%
- Have been hospitalized for heart failure within 5 years prior to Screening
- Have uncontrolled severe hypertension
- Have a formal diagnosis of homozygous familial hypercholesterolemia
- HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening
- active liver disease
Where it is running
20 locations listed across 13 US states.
- 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