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

Official 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.

Eligibility Requirements

• Minimum Age: 40 Years

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 15,374 participants

Study Arms

• Tirzepatide (EXPERIMENTAL)
  Participants will receive escalated doses of tirzepatide subcutaneously (SC) up to a maximum tolerated dose.
• Placebo (PLACEBO_COMPARATOR)
  Participants will receive tirzepatide matched placebo.

Interventions

• DRUG: Tirzepatide — Administered SC
• DRUG: Placebo — Administered SC

Primary Outcomes

• 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)

Secondary Outcomes

• Time to Onset of Type 2 Diabetes (T2D) (Up to 5 Years)
• Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) (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) (Up to 5 Years)
• Mean Change from Baseline Short Form-36 Version 2 (SF-36 v2) Acute Form Physical Functioning Domain Score (Baseline, 2 Years)
• Time to the Occurrence of All-cause Death (Up to 5 Years)

Eligibility Criteria

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.

Trial Locations

• 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
• ...and 10 more locations

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) — STUDY_DIRECTOR
  Eli Lilly and Company

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