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

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT03131687

Run by

Eli Lilly and Company

People needed

318

Starts

2017-05-24

Expected to finish

2018-08-01

Last updated by the study team

2019-08-20

Who can join

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

You may qualify if…

• Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification.
• 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) ≥23 and <50 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.
• 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

• Internal Medicine Center LLC — Mobile, Alabama, United States
• Anaheim Clinical Trails — Anaheim, California, United States
• Valley Research — Fresno, California, United States
• National Research Institute — Huntington Park, California, United States
• National Research Institute — Los Angeles, California, United States
• Catalina Research Institute — Montclair, California, United States
• Valley Clinical Trails, Inc — Northridge, California, United States
• Artemis Institute For Clinical Research — San Diego, California, United States
• Artemis Institute For Clinical Research — San Marcos, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• University Clinical Investigators INC — Tustin, California, United States
• Chase Medical Research — Waterbury, Connecticut, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• East Coast Institute For Research — Jacksonville, Florida, United States
• Suncoast Research Group, LCC — Miami, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• Sensible Healthcare — Ocoee, Florida, United States
• Palm Harbor Medical Associate — Palm Harbor, Florida, United States
• Solaris Clinical Research — Meridian, Idaho, United States
• Iderc P.L.C. — West Des Moines, Iowa, United States
• Cotton O'Neil Diabetes and Endocrine — Topeka, Kansas, United States
• ActivMed Practices & Research — Methuen, Massachusetts, United States
• Clinical Research Professionals — St Louis, Missouri, United States
• Palm Research Center — Las Vegas, Nevada, United States
• Premier Research — Trenton, New Jersey, United States

Full record on ClinicalTrials.gov

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