Trials Today

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

Purpose

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.

Conditions

Obesity
Overweight

Eligibility

Eligible Ages: Over 40 Years
Eligible Sex: All
Accepts 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.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Tirzepatide	Participants will receive escalated doses of tirzepatide subcutaneously (SC) up to a maximum tolerated dose.	Drug: Tirzepatide Administered SC Other names: LY3298176
Placebo Comparator Placebo	Participants will receive tirzepatide matched placebo.	Drug: Placebo Administered SC

Recruiting Locations

More Details

NCT ID: NCT05556512
Status: Active, not recruiting
Sponsor: Eli Lilly and Company

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.