A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus

In brief

The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone. The study will last approximately 47 weeks and may include about 15 visits.

Key facts

Study ID

NCT03954834

Run by

Eli Lilly and Company

People needed

478

Starts

2019-06-03

Expected to finish

2020-10-28

Last updated by the study team

2021-10-20

Who can join

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

You may qualify if…

• Have been diagnosed with type 2 diabetes mellitus (T2DM).
• Are naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAMs) during the 3 months preceding screening.
• Have HbA1c between ≥7.0% and ≤9.5%.
• Be of stable weight (± 5%) for at least 3 months before screening.
• Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening.

You may not qualify if…

• Have type 1 diabetes mellitus.
• Have had chronic or acute pancreatitis any time prior to study entry.
• Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.
• Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.
• Have an estimated glomerular filtration rate <30 mL/minute/1.73 m².
• Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.
• Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.
• Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.

Where it is running

• National Research Institute — Los Angeles, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Valley Clinical Trials, Inc. — Northridge, California, United States
• National Research Institute — Panorama City, California, United States
• Southern California Dermatology — Santa Ana, California, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• Encore Medical Research, LLC — Hollywood, Florida, United States
• Axcess Medical Research — Loxahatchee Groves, Florida, United States
• South Florida Wellness & Clinical Research Institute — Margate, Florida, United States
• Suncoast Research Group, LLC — Miami, Florida, United States
• Agile Clinical Research Trials — Atlanta, Georgia, United States
• Sky Clinical Research Network — Atlanta, Georgia, United States
• Cotton O'Neil Clinic — Topeka, Kansas, United States
• Clinical Research Professionals — Chesterfield, Missouri, United States
• StudyMetrix Research, LLC — City of Saint Peters, Missouri, United States
• Aventiv Research — Columbus, Ohio, United States
• Intend Research — Norman, Oklahoma, United States
• The Corvallis Clinic P.C. — Corvallis, Oregon, United States
• Heritage Valley Medical Group, Inc. — Beaver, Pennsylvania, United States
• Family Medical Associates — Levittown, Pennsylvania, United States
• Preferred Primary Care Physicians — Pittsburgh, Pennsylvania, United States
• Preferred Primary Care Physicians — Uniontown, Pennsylvania, United States
• Dallas Diabetes Endocrine Center — Dallas, Texas, United States
• Clinical Trials of Texas, Inc. — San Antonio, Texas, United States
• National Research Institute — Huntington Park, California, United States

Full record on ClinicalTrials.gov

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