Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Eduardo Grunvald

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

  • UCSD - Altman Clinical and Translational Research Institute (ACTRI) not yet accepting patients
    La Jolla California 92037 United States
  • Scripps Whittier Diabetes Institute accepting new patients
    La Jolla California 92037 United States
  • Artemis Institute for Clinical Research accepting new patients
    San Diego California 92103 United States
  • Acclaim Clinical Research not yet accepting patients
    San Diego California 92120 United States
  • Velocity Clinical Research, San Diego accepting new patients
    La Mesa California 91942 United States
  • Neighborhood Healthcare Institute of Health accepting new patients
    Escondido California 92025 United States

Lead Scientist at UCSD

  • Eduardo Grunvald
    Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 20 research publications

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