A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3819469 in Adults With Elevated Lipoprotein(a)

CompletadoFase 2ClinicalTrials.gov

ID: NCT05565742Tipo: INTERVENTIONALInicio: 20 de oct de 2022Fin estimado: 17 de oct de 2024

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to determine the efficacy and safety of LY3819469 in adults with elevated lipoprotein(a). The study will lasts about 20 months.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

Participants must be at least 40 years old at the time of signing the informed consent.
Participants with Lp(a) ≥175 nmol/L at screening, measured at the central laboratory
Participants on the following medications according to local practice must be on a stable regimen for at least 4 weeks prior to screening and randomization and expected to remain on a stable regimen through the end of the Treatment and Assessment Period:
lipid-lowering drugs
testosterone, estrogens, anti-estrogens, progestins, selective estrogen receptor modulators, or growth hormone
Have a body mass index within the range 18.5 to 40 kilogram/square meter (kg/m²), inclusive.
Male and/or Female
Males who agree to use highly effective/effective methods of contraception may participate in this trial.
Women not of childbearing potential (WNOCBP) may participate in this trial.

Criterios de exclusión

Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the investigator, would potentially affect participant safety within the study or interfere with participating in or completing the study or with the interpretation of data.
Any of the following, or other events indicating unstable medical condition in the opinion of the investigator, within 3 months of randomization:
major surgery
coronary, carotid, or peripheral arterial revascularization
stroke or transient ischemic attack
myocardial infarction or unstable angina
acute limb ischemia
Have, in the 6 months prior to day 1, uncontrolled Type 1 or Type 2 diabetes.
Have uncontrolled hypertension

Intervenciones

drug

LY3819469

Administered SC

drug

Placebo

Administered SC

Ubicaciones

Mautalen Salud e Investigación

Buenos Aires, Buenos Aires F.D., Argentina

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina

Glenny Corp. S.A.

Buenos Aires, Ciudad Aut, Argentina

Investigaciones Medicas Imoba Srl

Balvanera, Ciudad Autónoma de Buenos Aire, Argentina

CIPREC

Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina

Centro Modelo de Cardiología

San Miguel de Tucumán, Tucumán Province, Argentina

Investigaciones Clínicas Tucumán

San Miguel de Tucumán, Tucumán Province, Argentina

CEMEDIC

Buenos Aires, Argentina

Hospital San Roque

Córdoba, Argentina

Centro Cardiovascular Salta

Salta, Argentina

Centro de Investigaciones Clinicas del Litoral

Santa Fe, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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