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Clinical Trials in the UK / NCT05556512
Active, not recruiting Phase 3

A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity

NCT05556512 · tracked via the Priya Life Science UK tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2022-10-11
Last updated
2026-01-12

Condition(s) studied

ObesityOverweight

Investigational drug(s) / intervention(s)

TirzepatidePlacebo

Tirzepatide: Administered SC

Placebo: Administered SC

Study 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

Sex
ALL
Min age
40 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (671)

FacilityCityRegionStatus
Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC Gilbert Arizona
Aventiv Research Mesa Arizona
Elite Clinical Studies Phoenix Arizona
Pima Heart Tucson Arizona
KLR Business Group, Inc. dba Arkansas Clinical Research Little Rock Arkansas
Smart Cures Clinical Research Anaheim California
Kidney & Hypertension Center - Apple Valley Apple Valley California
Hope Clinical Research, Inc. Canoga Park California
John Muir Physician Network Research Center Concord California
Neighborhood Healthcare Institute of Health Escondido California
HB Clinical Trials - Fountain Valley Fountain Valley California
Valiance Clinical Research Huntington Park California
Scripps Whittier Diabetes Institute La Jolla California
Velocity Clinical Research, San Diego La Mesa California
First Valley Medical Group Lancaster California
Long Beach Clinical Trials Long Beach California
Infinity Clinical Research - Norco Norco California
California Medical Research Associates Northridge California
Diabetes Associates Medical Group Orange California
University of California Irvine Medical Center Orange California
FOMAT Medical Research Oxnard California
Desert Oasis Healthcare Medical Group Palm Springs California
Dream Team Clinical Research Pomona California
Rancho Cucamonga Clinical Research Rancho Cucamonga California
Artemis Institute for Clinical Research Riverside California
Artemis Institute for Clinical Research San Diego California
Acclaim Clinical Research San Diego California
Velocity Clinical Research, Santa Ana Santa Ana California
Valiance Clinical Research Tarzana California
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California
Diablo Clinical Research, Inc. Walnut Creek California
Millennium Clinical Trials Westlake Village California
University of Colorado Anschutz Medical Campus Aurora Colorado
Optum- Southwestern Colorado Springs Colorado
Kidney Associates of Colorado Denver Colorado
OptumCare Clinical Trials, LLC Golden Colorado
Clinical Research Consulting Milford Connecticut
Cardiology Associates of Fairfield County, P.C. Stamford Connecticut
Chase Medical Research, LLC Waterbury Connecticut
Excel Medical Clinical Trials Boca Raton Florida

+ 631 more sites — see the full list on the official registry below.

On this site

📄 Mounjaro (tirzepatide) drug profile →

More Eli Lilly and Company trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05556512 on ClinicalTrials.gov ↗ ← All trials in the UK