ACCLAIM-Lp(a)

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). Approximately 1700 additional participants will be enrolled in an addendum to explore Lp(a) lowering with an alternative dosing schema.

Criteria:
Inclusion Criteria:

  • Have Lipoprotein(a) [Lp(a)] ≥175 nanomoles per liter (nmol/L).
  • Meet criteria of either a or b:
    1. Individuals 18 years of age or older with established atherosclerotic cardiovascular disease (ASCVD) with an event or revascularization.
    2. Individuals 55 years of age or older who are at risk for a first cardiovascular (CV) event and 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 high-risk factors.

Exclusion Criteria:

  • Have had STEMI/NSTEMI, coronary CABG/PCI/stenting/revascularization, carotid stenting, ischemic stroke, peripheral revascularization, or amputations
  • New York Heart Association class IV heart failure
  • Within 5 years of screening Visit 1, have a known coronary artery calcium score of 0
  • Severe renal failure, defined as eGFR <15 mL/min/1.73 m2 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, known cirrhosis, signs and symptoms of any other liver disease other than metabolic-associated steatotic liver disease, or exclusionary laboratory results as determined by the central laboratory during screening.
  • Are pregnant, breastfeeding, or plan on becoming pregnant or breastfeeding during the study.
  • Have taken lepodisiran, muvalaplin, pelacarsen, olpasiran, zerlasiran, obicetrapib, or any medication used or under investigation for lowering Lp(a).

Location: Hartford Hospital
ClinicalTrials.gov Link: https://clinicaltrials.gov/study/NCT06292013
Sponsor: Eli Lilly and Company 
Contact: Fernandez Keelyn Kotecki 860-972-1696 Keelyn.Kotecki@hhchealth.org