A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

The purpose of this study is to determine the efficacy of tirzepatide in participants with type 2 diabetes.

Key facts

Study ID

NCT03311724

Run by

Eli Lilly and Company

People needed

111

Starts

2017-10-19

Expected to finish

2018-04-24

Last updated by the study team

2021-05-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have type 2 diabetes (T2DM) for ≥6 months according to the Criteria for Diagnosing Type 2 Diabetes Mellitus (American Diabetes Association 2017).
• Have HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory.
• If on metformin, have been treated with stable doses of metformin for at least 3 months.
• Have a body mass index (BMI) between 23 and 45 (Inclusive) kilograms per square meter.

You may not qualify if…

• Have type 1 diabetes (T1D).
• Have used any glucose-lowering medication other than metformin within 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past 12 months.
• Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke).
• Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial.
• Have had chronic or acute pancreatitis any time prior to study entry.
• Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation.
• Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry.
• Have any condition that is a contraindication for use of the GLP-1 RA class (per country-specific labels) at study entry or develop such condition between study entry and randomization.

Where it is running

• Valley Research — Fresno, California, United States
• National Research Institute — Los Angeles, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• University Clinical Investigators, Inc. — Tustin, California, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• Suncoast Research Group, LLC — Miami, Florida, United States
• Solaris Clinical Research — Meridian, Idaho, United States
• Cotton O'Neil Diabetes and Endocrinology Center — Topeka, Kansas, United States
• Clinical Research Professionals — St Louis, Missouri, United States
• Aventiv Research — Columbus, Ohio, United States
• New Phase Research & Development — Knoxville, Tennessee, United States
• Dallas Diabetes Endocrine Center — Dallas, Texas, United States
• Consano Clinical Research — Shavano Park, Texas, United States

Full record on ClinicalTrials.gov

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