A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes, Overweight, Obesity

In brief

This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits).

Key facts

Study ID

NCT04657003

Run by

Eli Lilly and Company

People needed

938

Starts

2021-03-29

Expected to finish

2023-04-10

Last updated by the study team

2024-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have Type 2 Diabetes (T2DM) with HbA1c ≥7% to ≤10% at screening, on stable therapy for the last 3 months prior to screening. T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs)
• Have a BMI of ≥27 kg/m²
• Are overweight or have obesity
• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
• Are at least 18 years of age and age of majority per local laws and regulations

You may not qualify if…

• Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM
• Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values >270 mg/dL(on 2 nonconsecutive days) prior to Visit 3
• Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
• Have self-reported change in body weight >5kg within 3 months prior to screening
• Have had a history of chronic or acute pancreatitis
• Change in body weight greater than 5 kg within 3 months prior to starting study
• Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
• Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
• History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
• Any lifetime history of a suicide attempt

Where it is running

• KLR Business Group, Inc. dba Arkansas Clinical Research — Little Rock, Arkansas, United States
• Velocity Clinical Research, Huntington Park — Huntington Park, California, United States
• Velocity Clinical Research, Westlake — Los Angeles, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• University Clinical Investigators, Inc. — Tustin, California, United States
• ALL Medical Research, LLC — Cooper City, Florida, United States
• Northeast Research Institute (NERI) — Fleming Island, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• West Orange Endocrinology — Ocoee, Florida, United States
• Metabolic Research Institute, Inc. — West Palm Beach, Florida, United States
• Emory University School of Medicine- Grady Campus — Atlanta, Georgia, United States
• East Coast Institute for Research, LLC — Macon, Georgia, United States
• Pacific Diabetes & Endocrine Center — Honolulu, Hawaii, United States
• Elite Clinical Trials — Blackfoot, Idaho, United States
• Rocky Mountain Clinical Research — Idaho Falls, Idaho, United States
• American Health Network of Indiana, LLC - Greenfield — Greenfield, Indiana, United States
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
• Cotton O'Neil Clinical Research Center — Topeka, Kansas, United States
• Maryland Cardiovascular Specialists — Baltimore, Maryland, United States
• MD Medical Research — Oxon Hill, Maryland, United States
• NECCR PrimaCare Research — Fall River, Massachusetts, United States
• Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy, Michigan, United States
• Logan Health Research — Kalispell, Montana, United States
• University of Alabama - Department of Nutrition Sciences — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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