A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes

Running, not enrolling · Phase 4

Conditions studied: Type 2 Diabetes

In brief

This study aims to investigate the efficacy and safety of tirzepatide in participants with type 2 diabetes (T2D) compared to other existing treatment options when treatment is initiated early.

Key facts

Study ID

NCT05433584

Run by

Eli Lilly and Company

People needed

780

Starts

2022-08-01

Expected to finish

2027-11-01

Last updated by the study team

2025-12-12

Who can join

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

You may qualify if…

• Have, within the last 4 years, been diagnosed with T2D based on the World Health Organization classification or other locally applicable diagnostic standards.
• Have HbA1c ≥7% to ≤9.5% as determined by the central laboratory.
• Have been on a stable treatment of metformin only at least 90 days preceding baseline
• with the minimum effective dose of ≥1500 mg/day, but not higher than the maximum approved dose per country-specific label, or
• <1500 mg/day in case of intolerance of full therapeutic dose.

You may not qualify if…

• Have type 1 diabetes mellitus
• Have a history of chronic or acute pancreatitis any time prior to study entry
• Have a history of
• proliferative diabetic retinopathy
• diabetic macular edema, or
• no proliferative diabetic retinopathy requiring immediate or urgent treatment
• Are at high risk for cardiovascular disease (CVD) in the investigator's opinion or have a history of any of these CV conditions prior to study entry
• myocardial infarction
• percutaneous coronary revascularization procedure
• carotid stenting or surgical revascularization
• nontraumatic amputation
• peripheral vascular procedure (e.g., stenting or surgical revascularization)
• cerebrovascular accident (stroke), or congestive heart failure
• Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
• Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over the counter, or alternative remedies
• Have an estimated glomerular filtration rate (eGFR) <30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by chronic kidney disease-epidemiology equation as determined by central laboratory at screening.
• Have been treated with any injectable glucagon-like peptide-1 (GLP-1) receptor agonists and insulin prior to screening.
• Exception: use of insulin for gestational diabetes or short-term use (<14 days) for acute conditions such as acute illness, hospitalization, or elective surgery.

Where it is running

• Bluewater Clinical Research Group Inc. — Sarnia, Ontario, Canada
• Cahaba Research - Trussville — Birmingham, Alabama, United States
• San Fernando Valley Health Institute — Canoga Park, California, United States
• Velocity Clinical Research, Huntington Park — Huntington Park, California, United States
• Velocity Clinical Research, San Diego — La Mesa, California, United States
• Clinical Trials Research — Lincoln, California, United States
• Velocity Clinical Research, Westlake — Los Angeles, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Velocity Clinical Research, North Hollywood — North Hollywood, California, United States
• Velocity Clinical Research, Panorama City — Panorama City, California, United States
• Western University of Health Sciences — Pomona, California, United States
• Velocity Clinical Research, Santa Ana — Santa Ana, California, United States
• New England Research Associates, LLC — Bridgeport, Connecticut, United States
• Excel Medical Clinical Trials — Boca Raton, Florida, United States
• Alliance for Multispecialty Research, LLC — Coral Gables, Florida, United States
• South Florida Clinical Research Institute — Margate, Florida, United States
• Emory University School of Medicine- Grady Campus — Atlanta, Georgia, United States
• Center for Advanced Research & Education — Gainesville, Georgia, United States
• Qualmedica Research, LLC — Evansville, Indiana, United States
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
• Qualmedica Research — Bowling Green, Kentucky, United States
• NECCR PrimaCare Research — Fall River, Massachusetts, United States
• SKY Integrative Medical Center/SKYCRNG — Ridgeland, Mississippi, United States
• StudyMetrix Research — City of Saint Peters, Missouri, United States
• Stouffville Medical Centre — Stouffville, Ontario, Canada

Full record on ClinicalTrials.gov

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