Quebec Health Research

En
Fr En
Sign in
Sign up

Your search

Reset search

Filters

Previous project
Next project
We check with each center if new information is available.

18812

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)
Source : Import from center

clinicaltrials.gov reference: NCT06292013
ASCVD
LY3819469
lepodisiran
Source : Import from center
Cardiology and vascular diseases
Endocrinology and Metabolism
Not applicable
Not applicable
Recruiment partially open
Last modification : 2025/07/22
Participating centers
6
733
Study type

Interventional

Experimental drug

PHASE3

Target population

Medical condition (targeted specialty)

Therapeutic area choices

Cardiology and vascular diseases

Endocrinology and Metabolism

Cancer stages

Not applicable

Biomarker

Not applicable

Participants profils

Participants gender(s)

ALL

Source : Import from center
Subjects aptitude

Selection criterias

Inclusion criteria

Inclusion Criteria:

* Have Lipoprotein(a) \[Lp(a)\] ≥175 nanomoles per liter (nmol/L).
* Meet criteria of either 2a or 2b:

2a: Individuals 18 years of age or older with established atherosclerotic cardiovascular disease (ASCVD) with an event or revascularization.

2b: 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 a major cardiovascular event or surgery, such as myocardial infarction (MI), stroke or coronary or peripheral revascularization, \< 60 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, 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.

Source : Import from center
Exclusion criteria

Évènements cardiovasculaires ou chirurgies majeurs dans les 90 jours avant la Sélection, hypertension non contrôlée, Score NYHA IV d'insuffisance cardiaque, Score de calcium coronaire connu de 0 dans les 5 dernières années avant la Sélection, Présence d'aphérèse des lipoprotéines dans les 90 jours avant la Sélection ou planifié durant l'étude, Insuffisance rénale sévère, Diagnostic d'un syndrome néphrotique actif, ou UACR >= 565 mg/mmol, Hépatit chronique ou aigue, autres maladies hépatiques à l'exception d'une stéatose non alcoolique, résultat de laboratoire AST/ALT ou Bilirubine totale anormaux, Présence ou historique d'un néoplasme malin dans les 5 dernières années avant la Sélection, Présence d'une infection active à la Sélection, Historique de prise de Lepodisiran, de Mulvalaplin, de Pelacarsen, d'Olpasiran, de Zerlasiran, d'Obicetrapib ou autres médicaments pouvant abaisser les Lp(a).

Source : Import from center

Proposed Therapy or Intervention

Cohorts
Name Medical condition Treatment Recruitment status
Lepodisiran Sodium Lepodisiran sodium administered subcutaneously (SC). Data not available
  • Unknown
    		•
    Placebo Placebo administered SC. Data not available
  • Unknown
    		•
    Lepodisiran Sodium
    Recruitment status
    unknown
    Placebo
    Recruitment status
    unknown
    Current data since : July 22, 2025 20:00

    Study description

    Study summary

    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.

    Source : Import from center

    Locations

    Participating centers

    Last modification : July 22, 2025
    Current data since : 30 Jul 17:56
    Data source : clinicaltrials.gov, Nagano
    clinicaltrials.gov reference: NCT06292013

    Liked this project?

    Share
    Save as PDF
    Save

    Related projects

    We are looking for similar projects that might interest you
    Back
    Home
    Search
    Quebec Health Research
    About us Contact FAQ Our partners Legal notice

    Quebec Health Research © 2023