A Study of Lepodisiran (LY3819469) in Adults With Elevated Lipoprotein(a) -ACCLAIM-Lp(a)

Phase 1

• Conditions: Atherosclerotic Cardiovascular Disease Elevated lp(a); Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-509190-23-00
• Lead Sponsor: Eli Lilly & Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-17
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12500

Inclusion Criteria

Have Lipoprotein(a) [Lp(a)] =175 nanomoles per liter (nmol/L) at pre-screening visit or screening visit as measured by the central laboratory., 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 = 90 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 with the following required number of risk factors for first CV event at screening visit., Must 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

Have had a major cardiovascular event or surgery, such as myocardial infarction (MI), stroke or coronary or peripheral revascularization, < 90 days before screening Visit 1 or between the screening Visit 1 and the randomization Visit 2., 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., Have New York Heart Association class IV heart failure., Within 5 years of screening Visit 1, have a known coronary artery calcium score of 0, or if the individual has more than one score during this time, 0 is the highest value., Have lipoprotein apheresis within 90 days of screening, or planned lipoprotein apheresis during the study., 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, Have a diagnosis of active nephrotic syndrome, or urine albumin-creatinine ratio (UCAR) of =5000 mg/g at screening Visit 1., Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease, or any of these laboratory results as determined by the central laboratory at screening.

Study & Design

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