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New diabetes drug shows promise for early treatment

NCT ID NCT05433584

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares the long-term effects of tirzepatide, a newer diabetes medication, with standard treatments in 780 adults who were diagnosed with type 2 diabetes within the last 4 years. Participants must be on metformin alone and have moderately high blood sugar levels. The main goal is to see how well tirzepatide controls blood sugar and weight over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 780 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes

Contacts and locations

Locations

  • 9109-0126 Quebec Inc.

    Montreal, Quebec, H4N 2W2, Canada

  • A.O.U. Policlinico Paolo Giaccone

    Palermo, Sicily, 90129, Italy

  • A.O.U.C. Policlinico di Bari

    Bari, Apulia, 70124, Italy

  • AOU Renato Dulbecco

    Catanzaro, 88100, Italy

  • Aberdeen Royal Infirmary

    Aberdeen, Aberdeen City, AB25 2ZN, United Kingdom

  • Alliance for Multispecialty Research, LLC

    Coral Gables, Florida, 33134, United States

  • Arztpraxis Christine Kosch Pirna

    Pirna, Saxony, 01796, Germany

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, Tuscany, 56124, Italy

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario, N7T 4X3, Canada

  • Bnai Zion Medical Center

    Haifa, Northern District, 3339419, Israel

  • C.M.D.T.A. Neomed

    Brasov, Brașov County, 500283, Romania

  • CIAD Moron

    Morón, Buenos Air, B1708EPE, Argentina

  • Cahaba Research - Trussville

    Birmingham, Alabama, 35235, United States

  • Catalina Research Institute, LLC

    Montclair, California, 91763, United States

  • Center for Advanced Research & Education

    Gainesville, Georgia, 30501, United States

  • Centro Cardiologico Monzino

    Milan, Milano, 20138, Italy

  • Centro Médico Viamonte

    Buenos Aires, Ciudad Aut, C1120AAC, Argentina

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aire, Buenos Aires, 1056, Argentina

  • Centrul Medical NutriLife

    Bucharest, Bucharest, 013764, Romania

  • Clalit Health Services - Atlit

    Atlit, Southern District, Israel

  • Clalit Health Services - Sakhnin Community Clinic

    Sakhnin, Northern District, 3081000, Israel

  • ClinPhenomics CVC GmbH

    Frankfurt am Main, Hesse, 60596, Germany

  • Clinica Korall

    Satu Mare, 440055, Romania

  • Clinical Research of Philadelphia

    Philadelphia, Pennsylvania, 19114, United States

  • Clinical Trials Research

    Lincoln, California, 95648, United States

  • Clinvest Research LLC

    Springfield, Missouri, 65807, United States

  • Dallas Diabetes Research Center

    Dallas, Texas, 75230, United States

  • Diabdana

    Oradea, Bihor County, 410147, Romania

  • Diabetes Zentrum Dr. Tews

    Gelnhausen, 63571, Germany

  • Diabetes- und Stoffwechselpraxis Bochum

    Bochum, North Rhine-Westphalia, 44869, Germany

  • Diabetespraxis Mergentheim

    Bad Mergentheim, 97980, Germany

  • Diabmed Dr. Popescu Alexandrina

    Ploieşti, Prahova, 100179, Romania

  • Dorado Medical Complex

    Dorado, 00646, Puerto Rico

  • Dr. M.B. Jones Inc.

    Victoria, British Columbia, V8V 4A1, Canada

  • Edith Wolfson Medical Center

    Holon, Central District, 5810001, Israel

  • Emory University School of Medicine- Grady Campus

    Atlanta, Georgia, 30303, United States

  • Excel Medical Clinical Trials

    Boca Raton, Florida, 33434, United States

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, PR, 00917, Puerto Rico

  • Gama Diamed

    Mangalia, Constanța County, 905500, Romania

  • Go Centro Medico San Nicolás

    San Nicolás de los Arroyos, Buenos Aires, 2900, Argentina

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 9112001, Israel

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 66460, Mexico

  • Hull Royal Infirmary

    Hull, Kingston Upon Hull, HU3 2JZ, United Kingdom

  • IRIDIA

    Vrútky, Žilina Region, 038 61, Slovakia

  • InnoDiab Forschung Gmbh

    Essen, North Rhine-Westphalia, 45136, Germany

  • Instituto de Investigaciones Clínicas Mar del Plata

    Mar del Plata, Buenos Aires, 7600, Argentina

  • Investigacion En Salud Y Metabolismo Sc

    Chihuahua City, 31217, Mexico

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50265, United States

  • JAL

    Trnava, 917 01, Slovakia

  • Kaplan Medical Center

    Rehovot, Central District, 7610001, Israel

  • Knowle House Surgery

    Plymouth, Devon, PL5 3JB, United Kingdom

  • Leicester General Hospital

    Leicester, Leicestershire, LE5 4PW, United Kingdom

  • Linn Medical Center

    Haifa, Ḥeifā, 3515209, Israel

  • Lucas Research, Inc

    Morehead City, North Carolina, 28557, United States

  • MEDIKALS

    Piešťany, 921 01, Slovakia

  • Milena Sante

    Galați, 800001, Romania

  • NECCR PrimaCare Research

    Fall River, Massachusetts, 02721, United States

  • New England Research Associates, LLC

    Bridgeport, Connecticut, 06606, United States

  • Ninewells Hospital and Medical School

    Dundee, Angus, DD1 9SY, United Kingdom

  • Ospedale Civile Santa Croce Pronto Soccorso

    Moncalieri, Piedmont, 10024, Italy

  • Ospedale san Giovanni di Dio-Diabetologia

    Olbia, Sardinia, 07026, Italy

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401, United States

  • Private Practice - Dr. Arechavaleta Granell Maria del Rosario

    Guadalajara, Jalisco, 44670, Mexico

  • ProDia s.r.o.

    Považská Bystrica, 017 01, Slovakia

  • Qualmedica Research

    Bowling Green, Kentucky, 42101, United States

  • Qualmedica Research, LLC

    Evansville, Indiana, 47715, United States

  • RED-Institut GmbH

    Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany

  • Rabin Medical Center

    Petah Tikva, Central District, 4941492, Israel

  • Research Foundation of SUNY - University of Buffalo

    Buffalo, New York, 14221, United States

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi, 39157, United States

  • San Fernando Valley Health Institute

    Canoga Park, California, 91304, United States

  • San Juan Bautista School of Medicine - Clinical Research Unit

    Caguas, PR, 00725, Puerto Rico

  • Sheba Medical Center

    Ramat Gan, Central District, 5262100, Israel

  • South Florida Clinical Research Institute

    Margate, Florida, 33063, United States

  • Staploe Medical Centre

    Ely, Cambridgeshire, CB7 5JD, United Kingdom

  • Stouffville Medical Centre

    Stouffville, Ontario, L4A 1H2, Canada

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303, United States

  • The Corvallis Clinic, P.C.

    Corvallis, Oregon, 97330, United States

  • Tribe Clinical Research, LLC

    Greenville, South Carolina, 29607, United States

  • University of Naples Federico II

    Naples, Campania, 80131, Italy

  • Velocity Clinical Research, Huntington Park

    Huntington Park, California, 90255, United States

  • Velocity Clinical Research, North Hollywood

    North Hollywood, California, 91606, United States

  • Velocity Clinical Research, Panorama City

    Panorama City, California, 91402, United States

  • Velocity Clinical Research, San Diego

    La Mesa, California, 91942, United States

  • Velocity Clinical Research, Santa Ana

    Santa Ana, California, 92704, United States

  • Velocity Clinical Research, Spartanburg

    Spartanburg, South Carolina, 29303, United States

  • Velocity Clinical Research, Westlake

    Los Angeles, California, 90057, United States

  • Western University of Health Sciences

    Pomona, California, 91766, United States

  • Wickersley Health Centre - Clifton Medical Centre

    Rotherham, S65 1DA, United Kingdom

  • Zentrum für klinische Studien

    Saint Ingbert, Saarland, 66386, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.