A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)

Description

The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin).

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD), Elevated Lp(a)

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Study Overview

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Study Details

Study overview

The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin).

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) Who Have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event - ACCLAIM-Lp(a)

A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)

Condition
Atherosclerotic Cardiovascular Disease (ASCVD)
Intervention / Treatment

-

Contacts and Locations

Birmingham

Birmingham Clinical Research, Birmingham, Alabama, United States, 35209

Daphne

Alliance for Multispecialty Research, LLC, Daphne, Alabama, United States, 36526

Dothan

SEC Clinical Research, Dothan, Alabama, United States, 36305

Mobile

Alliance for Multispecialty Research, LLC, Mobile, Alabama, United States, 36608

Mobile

Mobile Heart Specialists, Mobile, Alabama, United States, 36608

Gilbert

Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC, Gilbert, Arizona, United States, 85296

Gilbert

Mercy Gilbert Medical Center, Gilbert, Arizona, United States, 85297

Peoria

AMZERN Clinical Trial Organization, Peoria, Arizona, United States, 85381

Phoenix

Elite Clinical Studies, LLC, Phoenix, Arizona, United States, 85018

Phoenix

Helios Clinical Research - Phoenix, Phoenix, Arizona, United States, 85028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Have Lipoprotein(a) \[Lp(a)\] ≥175 nanomoles per liter (nmol/L).
  • * Meet criteria of either 2a or 2b:
  • * Have had a major cardiovascular event or surgery, such as myocardial infarction (MI), stroke or coronary or peripheral revascularization, \< 90 days before screening.
  • * Have uncontrolled hypertension
  • * Have New York Heart Association class IV heart failure.
  • * 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 (UACR) 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2029-03