A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)

CompletadoFase 3ClinicalTrials.gov

ID: NCT04847557Tipo: INTERVENTIONALInicio: 20 de abr de 2021Fin estimado: 2 de jul de 2024

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity.

Descripción detallada

The study will continue until approximately 52 weeks after the last participant is randomized. The maximum duration of an individual's participation is estimated to be \~120 weeks and will depend on duration of study enrollment.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

Have a diagnosis of stable heart failure (NYHA class II-IV) and left ventricular ejection fraction (LVEF) ≥50%
Elevated NT-proBNP (N-terminal pro B-type natriuretic peptide) \> 200 picogram/milliliter (pg/ml) for participants without atrial fibrillation (AF), or \>600 pg/ml for participants with AF, Structural heart disease (Left atrial enlargement) or Elevated left ventricular filling pressure
Estimated glomerular filtration rate (eGFR) \<70 milliliter (ml)/minute (min)/1.73m² at screening, or HF decompensation within 12 months of screening,
Stable dose of heart failure medications within 4 weeks of screening
Body mass index (BMI) ≥30 kilograms per meter squared (kg/m²)
MWD 100-425 meters
KCCQ CSS ≤80

Criterios de exclusión

Have had a major cardiovascular event within the last 90 days of screening
Have had acute decompensated heart failure within 4 weeks of screening
Have non cardiac causes of functional impairment such as pulmonary arterial hypertension (PAH), severe chronic obstructive pulmonary disease (COPD), anemia, thyroid disease, musculoskeletal disease or orthopedic conditions
Presence of cardiac amyloidosis, cardiac accumulation disease, cardiomyopathy and severe valvular heart disease
HbA1c ≥9.5% or uncontrolled diabetes
History of proliferative diabetic retinopathy or diabetic maculopathy
Have a history of pancreatitis
eGFR \<15 mL/min/1.73 m² or requiring dialysis at screening

Intervenciones

drug

Tirzepatide

Administered SC

other

Placebo

Administered SC

Ubicaciones

DIM Clínica Privada

Ramos Mejía, Buenos Aires, Argentina

Go Centro Medico San Nicolás

San Nicolás de los Arroyos, Buenos Aires, Argentina

Instituto Médico Especializado (IME)

Buenos Aires, Buenos Aires F.D., Argentina

Mautalen Salud e Investigación

Buenos Aires, Buenos Aires F.D., Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, Buenos Aires F.D., Argentina

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina

CIPREC

Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

Instituto de Investigaciones Clinicas Rosario

Rosario, Santa Fe Province, Argentina

CEMEDIC

Buenos Aires, Argentina

Fundación Respirar

Buenos Aires, Argentina

Instituto de Cardiología "Juana F. Cabral"

Corrientes, Argentina

Centro de Investigaciones Clinicas Instituto del Corazon (CICIC)

Córdoba, Argentina

Hospital de Alta Complejidad "Pte. Juan Domingo Perón"

Formosa, Argentina

Centro Cardiovascular Salta

Salta, Argentina

Instituto Cardiovascular San Luis

San Luis, Argentina

Centro de Investigaciones Clinicas del Litoral

Santa Fe, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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