JRCT ID: jRCT2031220466
Registered date:26/11/2022
A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Obesity Overweight |
Date of first enrollment | 19/12/2022 |
Target sample size | 15000 |
Countries of recruitment | Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Czechia,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,India,Japan,Israel,Japan,Italy,Japan,Korea, Republic of,Japan,Mexico,Japan,Netherlands,Japan,Poland,Japan,Puerto Rico,Japan,Romania,Japan,Slovakia,Japan,Spain,Japan,Taiwan,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan |
Study type | Interventional |
Intervention(s) | -Drug: Tirzepatide Administered SC Other Name: LY3298176 -Drug: Placebo Administered SC Study Arms -Experimental: Tirzepatide Participants will receive escalated doses of tirzepatide subcutaneously (SC) up to a maximum tolerated dose. Intervention: Drug: Tirzepatide -Placebo Comparator: Placebo Participants will receive tirzepatide matched placebo. Intervention: Drug: Placebo |
Outcome(s)
Primary Outcome | 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) [ Time Frame: 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. |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 40age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | -Have a body mass index (BMI) >=27.0 kilogram/square meter (kg/m2) -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. |
Exclude 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. |
Related Information
Primary Sponsor | Masaki Takeshi |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT05556512 |
Contact
Public contact | |
Name | Trial Guide Call Center |
Address | 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo Hyogo Japan 651-0086 |
Telephone | +81-120-023-812 |
LTG_CallCenter@lists.lilly.com | |
Affiliation | Eli Lilly Japan K.K. |
Scientific contact | |
Name | Takeshi Masaki |
Address | 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo Hyogo Japan 651-0086 |
Telephone | +81-120-023-812 |
LTG_CallCenter@lists.lilly.com | |
Affiliation | Eli Lilly Japan K.K. |