A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Obesity
Overweight
Спонсор: Eli Lilly and Company
Налично на:
БГ
Обобщение
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.
Кой може да участва
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.
Места на провеждане
27
Argentina (1)
CONEXA Investigacion Clinica S.A.
Buenos Aires
Австралия (1)
Nightingale Research
Adelaide
Белгия (1)
AZORG Campus Aalst-Moorselbaan
Aalst
Бразилия (1)
Centro de Pesquisa Clinica do Brasil
Brasília
Канада (1)
LMC Clinical Research Inc. (Brampton)
Brampton
Китай (1)
Peking University People's Hospital
Beijing
Чехия (1)
Kardiologicka ambulance
Brandýs nad Labem-Stará Boleslav
Франция (1)
Centre Hospitalier Sud Francilien
Corbeil-Essonnes
Германия (1)
Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair
Bad Homburg
Гърция (1)
General Hospital of Athens "G. Gennimatas"
Athens
Унгария (1)
DRC Gyógyszervizsgáló Központ
Balatonfüred
Индия (1)
Gujarat Endocrin Pvt Ltd
Ahmedabad
Израел (1)
Barzilai Medical Center
Ashkelon
Италия (1)
A.O.U.C. Policlinico di Bari
Bari
Япония (1)
Tokyo-Eki Center-building Clinic
Chūōku
Mexico (1)
Fundación Cardiovascular de Aguascalientes A.C.
Aguascalientes
Нидерландия (1)
Ziekenhuisgroep Twente, locatie Almelo
Almelo
Полша (1)
Osteo Medic sc A. Racewicz, J. Supronik
Bialystok
Puerto Rico (1)
Advanced Clinical Research, LLC
Bayamón
Румъния (1)
SC Minimed SRL
Bacau
Словакия (1)
MediTask
Bratislava
Южна Корея (1)
Korea University Ansan Hospital
Ansan-si
Испания (1)
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña
Taiwan (1)
Hsinchu Mackay Memorial Hospital
Hsinchu
Турция (1)
Çukurova Üniversitesi Tıp Fakültesi Adana Hastanesi
Adana
Великобритания (1)
Oakenhurst Medical Practice
Blackburn
САЩ (1)
Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC