MK-0616-013

Phase 1

• Conditions: Hypercholesterolemia; MedDRA version: 21.0Level: LLTClassification code: 10020604Term: Hypercholesterolemia Class: 10027433; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2022-502777-42-01
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-16
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2760

Inclusion Criteria

Has either: a.History of a major atherosclerotic cardiovascular disease (ASCVD) event b.If no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event, If history of a major ASCVD event: has LDL-C =55 mg/dL (=1.42 mmol/L), If no history of a major ASCVD event: has LDL-C =70 mg/dL (=1.81 mmol/L), At time of screening, is either: a.Treated with a moderate or high-intensity statin (± non-statin lipid-lowering therapy (LLT)). b.Treated with low-intensity statin (± non-statin LLT) with documentation of intolerance to a moderate or high-intensity statin c.Not receiving statins (± non-statin LLT) with documented evidence of intolerance to any dose of at least 2 different statins with at least one at the lowest approved dose, If on any LLTs (such as a statin and/or ezetimibe) should be on a stable dose for =30 days before screening with no planned medication or dose change during the participation in the study

Exclusion Criteria

Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria compound heterozygous FH, or double heterozygous FH, Has a history of heart failure or heart failure hospitalization within 3 months before first study visit, Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program, Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified