Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Andy Yen-Tang Lee
Headshot of Andy Yen-Tang Lee
Andy Yen-Tang Lee

Description

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.

Official Title

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

Keywords

Obesity, Overweight, Tirzepatide

Eligibility

You can join if…

Open to people ages 40 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California Irvine Medical Center not yet accepting patients
    Orange California 92868 United States
  • Velocity Clinical Research, Santa Ana accepting new patients
    Santa Ana California 92704 United States
  • HB Clinical Trials - Fountain Valley not yet accepting patients
    Fountain Valley California 92708 United States
  • Diabetes Associates Medical Group accepting new patients
    Orange California 92868 United States
  • Smart Cures Clinical Research not yet accepting patients
    Anaheim California 92806 United States
  • Long Beach Clinical Trials LLC not yet accepting patients
    Long Beach California 90806 United States
  • Infinity Clinical Research - Norco not yet accepting patients
    Norco California 92860 United States
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center accepting new patients
    Torrance California 90502 United States
  • Artemis Institute for Clinical Research not yet accepting patients
    Riverside California 92503 United States
  • Valiance Clinical Research accepting new patients
    S. Gate California 90280 United States

Lead Scientist at UC Irvine

  • Andy Yen-Tang Lee
    Assistant Health Sciences Professor, Medicine, School of Medicine

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
ID
NCT05556512
Phase
Phase 3 Obesity Research Study
Study Type
Interventional
Participants
Expecting 15000 study participants
Last Updated