LY3819469 SODIUM for Atherosclerotic cardiovascular disease | Elevated lipoprotein(a)

Inclusion criteria

• {"criterion_text":"- Have Lipoprotein(a) [Lp(a)] ≥175 nanomoles per liter (nmol/L) at pre-screening visit or screening visit as measured by the central laboratory.\n- Have disease characteristics of either 2a or 2b: 2a: Individuals 18 years of age or older with established atherosclerotic cardiovascular disease (ASCVD) with an event or revascularization ≥ 60 days before screening visit. Established ASCVD with history of an event or revascularization is defined as meeting at least one of the following: coronary artery disease; cerebral vascular disease, or peripheral arterial disease. 2b: Individuals 55 years of age or older who are at risk for a first cardiovascular (CV) events (i.e., have not had a prior CV event or revascularization) with the following required number of risk factors for first CV event at screening visit.\n- Must be 55 years or older and have either: Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without history of event or revascularization; known familial hypercholesteremia; or a combination of three or more high-risk factors."}

Exclusion criteria

• {"criterion_text":"- Have had a major cardiovascular event, such as myocardial infarction (MI), stroke or coronary or peripheral revascularization, or major surgery < 60 days before screening Visit 1 or between the screening Visit 1 and the randomization Visit 2.\n- Have uncontrolled hypertension at screening Visit 1 of • Systolic Blood Pressure (SBP) ≥180 millimeter of mercury (mm Hg) or • Diastolic Blood Pressure (DBP) ≥110 mm Hg.\n- Have New York Heart Association class IV heart failure.\n- Within 5 years of screening Visit 1, have a known coronary artery calcium score of 0, (this criterion applies only if participant has no evidence of ASCVD, specifically no history of ASCVD event or revascularization and has not had documented CAD or PAD).\n- Have lipoprotein apheresis within 90 days of screening, or planned lipoprotein apheresis during the study.\n- Have severe renal failure, defined as • Estimated glomerular rate (eGFR) <15 milliliters per minute per 1.73 meters squared (mL/min/1.73m2) at screening Visit 1, or ongoing dialysis\n- Have a diagnosis of active nephrotic syndrome, or urine albumin-creatinine ratio (UCAR) of ≥5000 mg/g at screening Visit 1.\n- Have acute or chronic hepatitis, known cirrhosis, signs and symptoms of any liver disease other than metabolic-associated steatotic liver disease, formerly nonalcoholic fatty liver disease, or any of these laboratory results as determined by the central laboratory at screening."}

Primary endpoints

• {"endpoint_text":"- 1. Time to First Occurrence Any Component of Major Adverse Cardiac Event (MACE)-4","definition_or_measurement_approach":"MACE-4 is defined as the composite of: CV death; Non-fatal myocardial infarction; Non-fatal ischemic stroke; and Urgent coronary revascularization. The primary endpoint is measured as time to first occurrence of any of these components during follow-up; events are subject to adjudication (adjudication role listed among third parties)."}

Methods

• Site referrals via healthcare professionals / doctor referral letters (site-to-patient recruitment) — documented doctor referral letters and site-based procedures.
• Printed materials at sites: posters, brochures and flyers targeting patients (country-specific brochures/posters present).
• Digital recruitment via Trialbee: landing pages, digital marketing content, Trialbee patient community outreach, and Trialbee secondary assessment and communication (digital/online channel targeting patients).
• Phone-based outreach using provided phone scripts for pre-screening and recruitment.
• Patient referral, recruitment, screening and retention through third-party vendors (e.g., Greenphire; vendor and service agreements indicated).
• Country-specific recruitment materials and procedures present (language- and country-specific ICFs, posters, brochures and Trialbee materials for multiple Member States as submitted).

Primary sponsor

Full Name

Eli Lilly & Co.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

IQVIA Rds Inc.

Responsibilities

sponsorDuties codes: 1; contact email: els.vannylen@iqvia.com

Name

Icon Clinical Research Limited

Responsibilities

sponsorDuties: 15 (Adjudication); contact email: Lisa.Boulanger@iconplc.com

Name

Labcorp Central Laboratory Services LP

Responsibilities

sponsorDuties codes: 4; contact email: rhonda.orem@labcorp.com

Third parties

• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: 4; contact email: rhonda.orem@labcorp.com","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"United-Power Pharma Tech Co. Ltd.","duties_or_roles":"sponsorDuties codes: 4; contact email: sophiayu@up-pharma.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Communication Brokers, Inc.","duties_or_roles":"sponsorDuties codes: 7; contact email: dpepin@cbitelecom.com","organisation_type":"Industry"}
• {"country":"Japan","full_name":"BML General Laboratory","duties_or_roles":"sponsorDuties codes: 4; contact email: rhonda.orem@labcorp.com","organisation_type":"Industry"}
• {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"sponsorDuties codes: 1; contact email: els.vannylen@iqvia.com","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: 4; contact email: rhonda.orem@labcorp.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"sponsorDuties: 15 (Patient Referral, Recruitment, Screening, and Retention); contact email: christian.keeney@greenphire.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties: 15 (Adjudication); contact email: Lisa.Boulanger@iconplc.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pyxant Labs Inc.","duties_or_roles":"sponsorDuties codes: 4; contact email: bonnie.richardson@pyxant.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Greece","full_name":"Pharmaserve Lilly S.A.C.I.","duties_or_roles":"sponsorDuties codes: 1,12,15 (including negotiation & execution of clinical trial agreements in Greece); contact email: clinops@lilly.gr","organisation_type":"Pharmaceutical company"}
• {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"sponsorDuties codes: 4; contact email: yanpingtracy.liu@labcorp.com","organisation_type":"Pharmaceutical company"}
• {"country":"Singapore","full_name":"LabCorp Development (Asia) Pte. Ltd.","duties_or_roles":"sponsorDuties codes: 4; contact email: rhonda.orem@labcorp.com","organisation_type":"Industry"}
• {"country":"United States","full_name":"Cleveland Clinic Foundation","duties_or_roles":"sponsorDuties codes: 11; contact email: brownk@ccf.org","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"sponsorDuties codes: 4; contact email: kara.harrison@bioagilytix.com","organisation_type":"Pharmaceutical company"}