Cardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease

• Status: Not yet recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with Atherosclerotic Cardiovascular Disease (ASCVD) who are not adequately controlled despite maximally tolerated lipid-lowering therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NewAmsterdam Pharma

Criteria

Inclusion Criteria:

• Males & females ≥ 18 years age.

• Established ASCVD

• On maximally tolerated lipid-modifying therapy

• Fasting LDL-C ≥ 80 mg/dL

• Fasting triglycerides < 400 mg/dL

• Estimated glomerular filtration rate ≥ 30 mL/min

Exclusion Criteria:

• 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

• Had non-fatal MI, non-fatal stroke, non-elective coronary revascularization and/or hospitalization for unstable angina or chest pain within past 3 months prior to screening

• Uncontrolled hypertension

• Diagnosis of homozygous familial hypercholesterolemia (HoFH)

• Active liver disease

• HbA1c ≥10%

• Thyroid Stimulating Hormone (TSH) > 1.5 times upper limit normal

• Creatine kinase > 3 times upper limit normal

• History of malignancy with surgery in past 3 years

• History of alcohol or drug abuse within past 5 years

• Received treatment with investigational product or device within past 30 days excluding Coronavirus treatment or vaccine

• Known allergy to study drug

• Participated in previous obicetrapib trial