This a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy and safety of LY3561774 administered subcutaneously at various doses in participants with mixed dyslipidemia and on a stable dose of a statin.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have fasting LDL-C ≥70 mg/dL (1.81 mmol/L) at screening.
Have fasting triglycerides (TGs) within the range of 150 (1.69 millimole/liter (mmoL) to 499 milligram/deciliter (mg/dL) 2.26 to 5.64 millimole/liter (mmol/L) at screening.
Have non-HDL-C ≥ 130 mg/dL (3.36 mmol/L) at screening.
Must be on a stable moderate or high-intensity dose of a statin for at least 2 months before screening and remain on the same medication and dose for the duration of the study.
Have a body mass index within the range of 18.5 to 40.0 kilogram/square meter (kg/m²), inclusive

Criterios de exclusión

Have in the 6 months prior to screening, uncontrolled Type 1 or Type 2 diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization, or have an hemoglobin A1c (HbA1c) ≥8% at screening.
Have a history of nephrotic syndrome.
Have a history of acute or chronic pancreatitis.
Have had within the past 3 months prior to screening
Myocardial infarction
Unstable angina
Coronary artery bypass graft
Percutaneous coronary intervention - diagnostic angiograms are permitted
Peripheral artery disease
Transient ischemic attack, or
Cerebrovascular accident
Have New York Heart Association Class III or IV heart failure or last known left ventricular ejection fraction \<30%.
Have undergone LDL apheresis within 12 months prior to screening.
Have clinically relevant anemia, as defined by the investigator.
Have, within 1 year prior to screening or plan on having during the study, surgical treatment for obesity.
Have within 3 years prior to screening a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse.
Have uncontrolled hypertension.
Have used or are taking products for the purpose of lowering lipid levels (except for statins, PCSK9 inhibitors, bempedoic acid, and ezetimibe). This includes lipid-regulating medication, over-the-counter products, or herbal therapies.

Ubicaciones

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina

Glenny Corp

Buenos Aires, Ciudad Aut, Argentina

CIPREC

CABA, Ciudad Aut, Argentina

Investigaciones Medicas Imoba Srl

Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Ciudad Autonoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, Argentina

Sanatorio San Martin

Venado Tuerto, Santa Fe Province, Argentina

Fundación Respirar

Buenos Aires, Argentina

Clínica Privada Velez Sarsfield

Córdoba, Argentina

Centro de Investigaciones Clinicas Instituto del Corazon (CICIC)

Córdoba, Argentina

Centro de Investigaciones Clinicas del Litoral

Santa Fe, Argentina

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3561774 in Adults With Mixed Dyslipidemia

Resumen