A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity
- Registration Number
- NCT05556512
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 15374
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Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m ²)
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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)
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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.
-
-
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Have type 1 diabetes (T1D) or (T2D), history of ketoacidosis, or hyperosmolar state/coma
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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
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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.
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Have a history of chronic or acute pancreatitis
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Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
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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
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Have a presence or history of malignant neoplasms within the past 5 years prior to screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive tirzepatide matched placebo. Tirzepatide Tirzepatide Participants will receive escalated doses of tirzepatide subcutaneously (SC) up to a maximum tolerated dose.
- Primary Outcome Measures
Name Time Method 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) 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.
- Secondary Outcome Measures
Name Time Method Time to First Occurrence of Any Component Event of Major Adverse Cardiovascular Events-3 (MACE-3) (CV Death, Nonfatal MI or Nonfatal Stroke) Up to 5 Years Time to first occurrence of any component event of MACE-3 (CV death, nonfatal MI or nonfatal stroke)
Time to the Occurrence of All-cause Death Up to 5 Years Time to Onset of Type 2 Diabetes (T2D) Up to 5 Years Time to First Occurrence of CV Death Up to 5 Years Time to First Occurrence of Stroke Up to 5 Years Percent Change from Baseline in Body Weight Baseline, 156 Weeks Time to First Occurrence of Coronary Revascularization Up to 5 Years Time to First Occurrence Heart Failure (HF) Events Up to 5 Years Time to first occurrence heart failure (HF) events that result in hospitalization or urgent visits
Change from Baseline in Systolic Blood Pressure (SBP) in Millimeter Mercury (mmHg) Baseline, 156 Weeks Percentage of Participants with Hemoglobin A1c (HbA1c) <39 Millimole/Mole (mmol/mol) (5.7%) Up to 5 Years 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.
Estimated Glomerular Filtration Rate (eGFR) Slope Up to 5 Years Time to First Occurrence of MI Up to 5 Years Change from Baseline Diastolic Blood Pressure (DBP) (mmHg) Baseline, 156 Weeks Mean Change from Baseline Short Form-36 Version 2 (SF-36 v2) Acute Form Physical Functioning Domain Score Baseline, 2 Years 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 to First Occurrence of Hospitalization for Unstable Angina Up to 5 Years Time to first occurrence of Hospitalization or Urgent Visit Up to 5 Years Time to first occurrence of hospitalization or urgent visit due to atrial fibrillation, or cardioversion or ablation for atrial fibrillation
Time to First Occurrence of Any Component Event of the Composite Endpoint (eGFR, ESRD, or Renal Death) Up to 5 Years Time to first occurrence of any component event of the composite endpoint ≥40% sustained decline in eGFR, ESRD, or renal death.
Trial Locations
- Locations (658)
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
Kidney & Hypertension Center - Apple Valley
🇺🇸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
Scroll for more (648 remaining)Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC🇺🇸Gilbert, Arizona, United States