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HomeTrials › NCT05433584

Type 2 diabetes · Phase 4 · Active, not recruiting

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

NCT05433584 · Sponsor: Eli Lilly and Company

What this trial means for you

This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Tirzepatide, Antihyperglycemic medication for type 2 diabetes.

Who can joinAll sexes, 18 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeTirzepatide, Antihyperglycemic medication
Study length~3.3 years overall
Planned participants780
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Study sites by state

Alabama

  • Cahaba Research - Trussville — Birmingham

California

  • San Fernando Valley Health Institute — Canoga Park
  • Velocity Clinical Research, Huntington Park — Huntington Park
  • Velocity Clinical Research, San Diego — La Mesa
  • Clinical Trials Research — Lincoln
  • Velocity Clinical Research, Westlake — Los Angeles
  • Catalina Research Institute, LLC — Montclair
  • Velocity Clinical Research, North Hollywood — North Hollywood
  • Velocity Clinical Research, Panorama City — Panorama City
  • Western University of Health Sciences — Pomona
  • Velocity Clinical Research, Santa Ana — Santa Ana

Connecticut

  • New England Research Associates, LLC — Bridgeport

Florida

  • Excel Medical Clinical Trials — Boca Raton
  • Alliance for Multispecialty Research, LLC — Coral Gables
  • South Florida Clinical Research Institute — Margate

Georgia

  • Emory University School of Medicine- Grady Campus — Atlanta
  • Center for Advanced Research & Education — Gainesville

Indiana

  • Qualmedica Research, LLC — Evansville

Iowa

  • Iowa Diabetes and Endocrinology Research Center — West Des Moines

Kentucky

  • Qualmedica Research — Bowling Green

Massachusetts

  • NECCR PrimaCare Research — Fall River

Mississippi

  • SKY Integrative Medical Center/SKYCRNG — Ridgeland

Missouri

  • StudyMetrix Research — City of Saint Peters
  • Clinvest Research LLC — Springfield

New York

  • Research Foundation of SUNY - University of Buffalo — Buffalo

North Carolina

  • Lucas Research, Inc — Morehead City

Oregon

  • The Corvallis Clinic, P.C. — Corvallis

Pennsylvania

  • Clinical Research of Philadelphia — Philadelphia
  • Preferred Primary Care Physicians — Uniontown

South Carolina

  • Tribe Clinical Research, LLC — Greenville
  • Velocity Clinical Research, Spartanburg — Spartanburg

Texas

  • Dallas Diabetes Research Center — Dallas

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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