MK-0616 versus Comparators Study in Adults with Hypercholesterolemia

Phase 1

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

• Registration Number: CTIS2023-504920-25-00
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-23
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Has either a) history of a major atherosclerotic cardiovascular disease (ASCVD) event or b) if no history of a major ASCVD event, has intermediate to high risk for development of a first major ASCVD event., Has fasted lipid values (evaluated by the central laboratory) at Visit 1 (Screening) as follows: a) history of a major ASCVD event with LDL-C =55 mg/dL (=1.42 mmol/L) OR b) No history of a major ASCVD event with LDL-C =70 mg/dL (=1.81 mmol/L), Is treated with a low, moderate, or high intensity statin (±non-statin lipid lowering therapy [LLT]), Is on a stable dose of all background LLTs with no planned medication or dose changes during the study., Is an individual of any sex/gender, from 18 years of age inclusive, at the time of providing the informed consent.

Exclusion Criteria

Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous familial hypercholesterolemia (HeFH), or double HeFH, Has New York Heart Association class IV heart failure, or last known left ventricular ejection fraction =25% by any imaging method, or had a heart failure hospitalization within 3 months before Visit 1 (Screening), Participants with a history of tendon disorder or tendon rupture, Participants with a history of gout, Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Visit 1 (Screening) 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