A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Obesity, Overweight
In brief
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.
Key facts
- Study ID
- NCT05556512
- Run by
- Eli Lilly and Company
- People needed
- 15374
- Starts
- 2022-10-11
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2026-01-12
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify 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.
Where it is running
- Bluewater Clinical Research Group Inc. — Sarnia, Canada
- Synergy Medical Clinic — Sherwood Park, Canada
- Centre de Medecine Metabolique de Lanaudiere (CMML) — Terrebonne, Canada
- LMC Clinical Research Inc. (Bayview) — Toronto, Canada
- Diabetes Heart Research Centre — Toronto, Canada
- Dr. Anil K. Gupta Medicine Professional Corporation — Toronto, Canada
- Dr. M.B. Jones Inc. — Victoria, Canada
- Peking University People's Hospital — Beijing, China
- Beijing Friendship Hospital Affiliate of Capital University — Beijing, China
- Universidad de Guadalajara — Guadalajara, Mexico
- Clinica de Investigacion en Reumatologia y Obesidad S. C. — Guadalajara, Mexico
- CICEJ Centro de Investigación Clínica Endocrinológica de Jalisco S.C — Guadalajara, Mexico
- Private Practice - Dr. Arechavaleta Granell Maria del Rosario — Guadalajara, Mexico
- Private Practice - Dr. Francisco Gerardo Padilla — Guadalajara, Mexico
- Unidad de Investigación Clínica y Atención Médica HEPA — Guadalajara, Mexico
- Virgen Cardiovascular Research SC — Guadalajara, Mexico
- Investigación Médica Sonora, S.C. — Hermosillo, Mexico
- Centro de Investigacion en Artritis y Osteoporosis SC — Mexicali, Mexico
- RM Pharma Specialists — Mexico City, Mexico
- Hospital de Jésus, I.A.P. — Mexico City, Mexico
- Caimed Investigacion En Salud S.A. de C.V. — Mexico City, Mexico
- Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares — Mexico City, Mexico
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran — Mexico City, Mexico
- EME RED Hospitalaria — Mérida, Mexico
- ALPHA Recherche Clinique — Québec, Canada
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.