MUVALAPLIN for Elevated lipoprotein(a) | Atherosclerotic cardiovascular disease

Inclusion criteria

• {"criterion_text":"- Have Lp(a) levels of 175 nmol/L or higher\n- Meet one of the following criteria: • Have had a previous heart-related event, such as a heart attack, stroke, or a procedure to restore blood flow to the heart or other parts of the body • Be at risk for a first heart-related event, defined by one or more of the following: • Coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without a previous heart-related event • A high coronary artery calcium (CAC) score • Reduced kidney function with diabetes • Combination(s) of high risk factors"}

Exclusion criteria

• {"criterion_text":"- Have had a major heart or blood vessel event within 90 days before screening\n- Be planning any heart or artery surgery\n- Have very high blood pressure or have serious heart failure\n- Have had or planning to have a procedure to remove cholesterol from the blood within 90 days of screening\n- Have severe kidney failure\n- Have a history of cancer within 5 years before screening"}

Primary endpoints

• {"endpoint_text":"- Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint","definition_or_measurement_approach":"Time-to-event (time from randomisation to first occurrence of any component of the MACE-4 composite). The study main objective is to evaluate reduction in risk of the composite MACE-4; endpoint is measured as time to first occurrence."}

Methods

• Posters, flyers and brochures (site-facing and participant-facing recruitment materials) - multiple country-specific versions available (e.g. FRA, PL, GR, ES, IT, BE, NL, etc.).
• Doctor-to-patient letters and doctor referral letters (site-mediated recruitment).
• Patient-facing eConsent / patient-facing landing page and participant-facing screenshots (electronic consent platform) for remote consent.
• Online recruitment campaign ads and platforms (documents list includes 'Recruitment Campaign Ads' and 'Recruitment Campaign Link2Trials' and other online ad materials).
• Website text and social media carousel/website recruitment content (e.g. Meclinas website text, carousel post images).
• Patient referral and recruitment services via third-party vendors/CROs (e.g. Clariness, Trialbee, Greenphire, Meclinas, PreCare/other recruitment vendors) and site-based recruitment.

Primary sponsor

Full Name

Eli Lilly & Co.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

Training

Name

Icon (Lr) Limited

Responsibilities

Adjudication

Name

IQVIA Biotech LLC

Responsibilities

code 1

Third parties

• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"eCOA translations","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"Adjudication","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"code 11","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"code 6","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Patient Referral, Recruitment, Screening, and Retention","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Singapore","full_name":"Labcorp Development (Asia) Pte Ltd","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"LabCorp Drug Development, Inc.","duties_or_roles":"code 4","organisation_type":"Health care"}
• {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"Pharmaserve Lilly S.A.C.I.","duties_or_roles":"Multiple sponsor duties including negotiation and execution of clinical trial agreements, study payments, and others (codes 1,12,15,value described: Negotiation and Execution of Clinical Trial Agreements with the participating sites, make study payments based on invoices, plus codes 2 and 5)","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Training","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Recruitment, Screening, and Retention","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Sweden","full_name":"Trialbee AB","duties_or_roles":"Patient Referral, Recruitment, Screening, and Retention","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Clariness GmbH (additional entry)","duties_or_roles":"Patient Referral, Recruitment, Screening, and Retention","organisation_type":"Non-Pharmaceutical company"}