Clinical trial

A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity

Active, not recruiting · Phase 3 · 1 countries · Registry ID NCT05556512

Active, not recruitingPhase 3Interventional

What this study is about

This study will investigate the effect of tirzepatide on the reduction of morbidity and mortality in adults living with obesity and provide additional evidence for the potential clinical benefits of tirzepatide in this population.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age40 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity, Overweight

Full registry criteria

Inclusion Criteria: * Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m ²) * Are either * individuals ≥40 years of age with established cardiovascular disease (CVD). * CVD is defined as meeting at least one of the following: * Coronary artery disease * Cerebrovascular disease * Peripheral arterial disease OR * individuals without established CVD but have the presence of cardiovascular (CV) risk factors (primary prevention) * women 55-69 years of age or men 50-64 years of age with at least 3 risk factors like tobacco use, dyslipidemia, hypertension at screening, or * women ≥70 years of age or men, ≥65 years of age with at least 2 risk factors at screening. Exclusion Criteria: * Have type 1 diabetes (T1D) or (T2D), history of ketoacidosis, or hyperosmolar state/coma * Have laboratory evidence diagnostic of diabetes mellitus at screening of HbA1c ≥6.5% (≥48 millimole/mole (mmol/mol) or fasting glucose (FG) ≥126 milligram/deciliter (≥7.0 millimole/liter (mmol/L). * Any one of the following CV conditions within 90 days prior to screening * MI * acute coronary syndrome * stroke * coronary or peripheral arterial revascularization procedure, which may also include carotid artery revascularization, or * acute decompensated heart failure * Have a known clinically significant gastric emptying abnormality such as severe gastroparesis or gastric outlet obstruction or have undergone or currently planning any gastric bypass (metabolic) surgery or restrictive bariatric surgery. Note: Liposuction or abdominoplasty are not considered as gastric bypass procedures. * Have a history of chronic or acute pancreatitis * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. * Have acute or chronic hepatitis, or clinical signs or symptoms of any other liver disease, or have elevated liver enzyme measurements, determined by the central laboratory at screening * Have a presence or history of malignant neoplasms within the past 5 years prior to screening.

Treatments and study arms

Tirzepatide

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

Time to First Occurrence of Any Component Event of Composite (All-Cause Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Coronary Revascularization, or Heart Failure Events)Up to 5 Years

Time to first occurrence of any component event of composite, all-cause death, nonfatal MI, nonfatal stroke, coronary revascularization, or heart failure events that results in hospitalization or urgent visits.

Study locations

671 locations were listed when this page was built. The first 40 are shown.

Asociación de Beneficencia Hospital Sirio Libanés🇦🇷 Buenos Aires, Argentina
CEMEDIC🇦🇷 Buenos Aires, Argentina
CENUDIAB🇦🇷 Buenos Aires, Argentina
CONEXA Investigacion Clinica S.A.🇦🇷 Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada🇦🇷 Buenos Aires, Argentina
Centro Médico Viamonte🇦🇷 Buenos Aires, Argentina
Centro Privado de Medicina Familiar / Mindout Research🇦🇷 Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)🇦🇷 Buenos Aires, Argentina
Consultorio de Investigación Clínica EMO SRL🇦🇷 Buenos Aires, Argentina
Fundación Respirar🇦🇷 Buenos Aires, Argentina
Glenny Corp. S.A.🇦🇷 Buenos Aires, Argentina
Instituto Médico Especializado (IME)🇦🇷 Buenos Aires, Argentina
Investigaciones Medicas Imoba Srl🇦🇷 Buenos Aires, Argentina
Mautalen Salud e Investigación🇦🇷 Buenos Aires, Argentina
Stat Research S.A.🇦🇷 Buenos Aires, Argentina
CEMEDIAB🇦🇷 C.a.b.a., Argentina
CEDIC🇦🇷 CABA, Argentina
CIPREC🇦🇷 CABA, Argentina
Centro Medico Privado CEMAIC🇦🇷 Capital, Argentina
CIDIM-Centro Integral de Diagnostico por Imagenes Marchegiani🇦🇷 Córdoba, Argentina
Centro Medico Privado San Vicente Diabetes🇦🇷 Córdoba, Argentina
Centro de Investigaciones Clinicas Instituto del Corazon (CICIC)🇦🇷 Córdoba, Argentina
Clínica Privada Velez Sarsfield🇦🇷 Córdoba, Argentina
Hospital San Roque🇦🇷 Córdoba, Argentina
Instituto Medico Strusberg🇦🇷 Córdoba, Argentina
Instituto Médico DAMIC🇦🇷 Córdoba, Argentina
Instituto de Investigaciones Clínicas Córdoba🇦🇷 Córdoba, Argentina
Sanatorio Privado Duarte Quirós🇦🇷 Córdoba, Argentina
MICA - Medicina e Investigación Cardiometabólica🇦🇷 Del Viso, Argentina
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes🇦🇷 Godoy Cruz, Argentina
Centro de Investigaciones Clínicas Baigorria🇦🇷 Granadero Baigorria, Argentina
CIMeL Clinical Research🇦🇷 Lanus, Argentina
Centro de Investigaciones Médicas Mar del Plata🇦🇷 Mar del Plata, Argentina
Instituto de Investigaciones Clínicas Mar del Plata🇦🇷 Mar del Plata, Argentina
Omega Salud🇦🇷 Mar del Plata, Argentina
Instituto de Cardiología Wolff🇦🇷 Mendoza, Argentina
CIAD Moron🇦🇷 Morón, Argentina
DIM Clínica Privada🇦🇷 Ramos Mejía, Argentina
Fundacion Estudios Clinicos🇦🇷 Rosario, Argentina
INECO Neurociencias Oroño🇦🇷 Rosario, Argentina