New investigational medication for patients with T2DM or metabolic syndrome
- Trial ID:
- IRB-26-8729
- Athena Philis-Tsimikas, M.D.
Inclusion Criteria
Patients must:
- Be 18 years of age or older
Have a known diagnosis of T2DM OR have metabolic syndrome and at least 2 risk factors
Be on stable guideline-recommended lipid-lowering therapy
Meet all other eligibility criteria
Exclusion Criteria
Patients must not:
- Have a 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
Have a HbA1c =10.0% (=0.100 hemoglobin fraction) or a fasting glucose =270 mg/dL (=15.0 mmol/L) at Screening
Have active liver disease
Additional Info
Approximately 300 participants will take part in this study to help doctors compare the safety and effectiveness of the investigational medicine, obicetrapib 10mg, when taken in combination with ezetimibe 10mg as a fixed dose combination (FDC) therapy or obicetrapib 10mg alone or placebo (no active ingredients). The study will also explore which treatment is better for treating high LDL-C (bad cholesterol) levels in blood.