A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity
Phase 3 – large-scale trial before approval
Conditions:
Obesity
Overweight
Sponsor: Eli Lilly and Company
trial.available_in:
БГ
Overview
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.
Who can participate
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.
Locations
27
Argentina (1)
CONEXA Investigacion Clinica S.A.
Buenos Aires
Australia (1)
Nightingale Research
Adelaide
Belgium (1)
AZORG Campus Aalst-Moorselbaan
Aalst
Brazil (1)
Centro de Pesquisa Clinica do Brasil
Brasília
Canada (1)
LMC Clinical Research Inc. (Brampton)
Brampton
China (1)
Peking University People's Hospital
Beijing
Czech Republic (1)
Kardiologicka ambulance
Brandýs nad Labem-Stará Boleslav
France (1)
Centre Hospitalier Sud Francilien
Corbeil-Essonnes
Germany (1)
Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair
Bad Homburg
Greece (1)
General Hospital of Athens "G. Gennimatas"
Athens
Hungary (1)
DRC Gyógyszervizsgáló Központ
Balatonfüred
India (1)
Gujarat Endocrin Pvt Ltd
Ahmedabad
Israel (1)
Barzilai Medical Center
Ashkelon
Italy (1)
A.O.U.C. Policlinico di Bari
Bari
Japan (1)
Tokyo-Eki Center-building Clinic
Chūōku
Mexico (1)
Fundación Cardiovascular de Aguascalientes A.C.
Aguascalientes
Netherlands (1)
Ziekenhuisgroep Twente, locatie Almelo
Almelo
Poland (1)
Osteo Medic sc A. Racewicz, J. Supronik
Bialystok
Puerto Rico (1)
Advanced Clinical Research, LLC
Bayamón
Romania (1)
SC Minimed SRL
Bacau
Slovakia (1)
MediTask
Bratislava
South Korea (1)
Korea University Ansan Hospital
Ansan-si
Spain (1)
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña
Taiwan (1)
Hsinchu Mackay Memorial Hospital
Hsinchu
Turkey (1)
Çukurova Üniversitesi Tıp Fakültesi Adana Hastanesi
Adana
United Kingdom (1)
Oakenhurst Medical Practice
Blackburn
United States (1)
Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC