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A Phase 3, Randomized, Double-blind, Placebo-Controlled Study to Investigate the Effect of Tirzepatide on the Reduction of Morbidity and Mortality in Adults With Obesity (I8F-MC-GPIJ)

A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity (I8F-MC-GPIJ)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Not Recruiting

Dec. 15, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-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.

-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.

Both

Obesity Overweight

-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

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.

+81-3-6262-2811

Oct. 14, 2022

Yes

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Argentina/Australia/Austria/Belgium/Brazil/Canada/China/Czechia/France/Germany/Greece/Hungary/India/Israel/Italy/Korea, Republic of/Mexico/Netherlands/Poland/Puerto Rico/Romania/Slovakia/Spain/Taiwan/Turkey/United Kingdom/United States