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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15,374
Administered SC
Administered SC
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 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.
Time frame: Up to 5 Years
Time to Onset of Type 2 Diabetes (T2D)
Time frame: Up to 5 Years
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
In participants with high or very high risk chronic kidney disease
Time frame: Up to 5 Years
Time to First Occurrence of Any Component Event of Major Adverse Cardiovascular Events-3 (MACE-3) (CV Death, Nonfatal MI or Nonfatal Stroke)
Time to first occurrence of any component event of MACE-3 (CV death, nonfatal MI or nonfatal stroke)
Time frame: Up to 5 Years
Mean Change from Baseline Short Form-36 Version 2 (SF-36 v2) Acute Form Physical Functioning Domain Score
The SF-36 v2 acute, 1-week recall version is a 36-item generic, participant-administered measure designed to assess the following 8 domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role - Emotional, and Mental Health. Each domain is scored individually and further aggregated into 2 health component summary scores, physical component and mental component summary. Scoring of each domain and both summary scores are norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function and/or better health.
Time frame: Baseline, 2 Years
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Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC
Gilbert, Arizona, United States
Aventiv Research
Mesa, Arizona, United States
Elite Clinical Studies
Phoenix, Arizona, United States
Pima Heart
Tucson, Arizona, United States
KLR Business Group, Inc. dba Arkansas Clinical Research
Little Rock, Arkansas, United States
Smart Cures Clinical Research
Anaheim, California, United States
Trident Clinical Research Services, Inc.
Apple Valley, California, United States
Hope Clinical Research, Inc.
Canoga Park, California, United States
John Muir Physician Network Research Center
Concord, California, United States
Neighborhood Healthcare Institute of Health
Escondido, California, United States
...and 661 more locations
Time to the Occurrence of All-cause Death
Time frame: Up to 5 Years
Time to First Occurrence of CV Death
Time frame: Up to 5 Years
Time to First Occurrence of MI
Time frame: Up to 5 Years
Time to First Occurrence of Stroke
Time frame: Up to 5 Years
Time to First Occurrence of Coronary Revascularization
Time frame: Up to 5 Years
Time to First Occurrence Heart Failure (HF) Events
Time to first occurrence heart failure (HF) events that result in hospitalization or urgent visits
Time frame: Up to 5 Years
Time to First Occurrence of Hospitalization for Unstable Angina
Time frame: Up to 5 Years
Time to first occurrence of Hospitalization or Urgent Visit
Time to first occurrence of hospitalization or urgent visit due to atrial fibrillation, or cardioversion or ablation for atrial fibrillation
Time frame: Up to 5 Years
Time to First Occurrence of Any Component Event of the Composite Endpoint (eGFR, ESRD, or Renal Death)
Time to first occurrence of any component event of the composite endpoint ≥40% sustained decline in eGFR, ESRD, or renal death.
Time frame: Up to 5 Years
Percent Change from Baseline in Body Weight
Time frame: Baseline, 156 Weeks
Change from Baseline in Systolic Blood Pressure (SBP) in Millimeter Mercury (mmHg)
Time frame: Baseline, 156 Weeks
Change from Baseline Diastolic Blood Pressure (DBP) (mmHg)
Time frame: Baseline, 156 Weeks
Percentage of Participants with Hemoglobin A1c (HbA1c) <39 Millimole/Mole (mmol/mol) (5.7%)
Percentage of participants with HbA1c \<39 mmol/mol (5.7%) at each time where HbA1c is assessed for participants with a screening HbA1c ≥39 mmol/mol.
Time frame: Up to 5 Years
Time to First Occurrence of Any Component Event of Composite Endpoint (All-Cause Death, Nonfatal MI, Nonfatal Stroke, Coronary Revascularization, Heart Failure Events, > 40% Sustained Decline in eGFR, or End Stage Renal Disease)
In participants with prediabetes
Time frame: Up to 5 Years