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New diabetes drug retatrutide takes on semaglutide in major trial

NCT ID NCT06260722

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new weekly medicine, retatrutide, against an existing one, semaglutide, in about 1250 adults with type 2 diabetes whose blood sugar is not well controlled by metformin. The goal is to see which works better at lowering blood sugar and weight over 26 months. Participants must have stable weight and a BMI of 25 or higher.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,250 people

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

Started

Feb 2024

Expected to finish

Jan 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 Type 2 Diabetes (T2D) * Have HbA1c ≥ 7.0% (53 millimoles per mole (mmol/mol)) to ≤ 10.5% (91 mmol/mol) * Have been on a stable diabetes treatment consisting of metformin ≥ 1500 milligrams per day (mg/day) with or without SGLT2i during 90 days prior to screening * Are of stable weight for at least 90 days prior to screening * Have a Body Mass Index (BMI) ≥ 25.0 kilograms per meter squared (kg/m\^2) Exclusion Criteria: * Have Type 1 Diabetes (T1D) * Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening * Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening * Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema * Have an estimated glomerular filtration rate (eGFR) \<45 milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory * Have a prior or planned surgical treatment for obesity * Have New York Heart Association Functional Classification IV congestive heart failure * Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening * Have a known clinically significant gastric emptying abnormality * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years * Have any lifetime history of a suicide attempt * Had chronic or acute pancreatitis * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2 * Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening.

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Conditions

The condition(s) this trial relates to.

endocrine system disorder glucose metabolism disease metabolic disease type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes mellitus type 2

Contacts and locations

Locations

  • 9109-0126 Quebec Inc.

    Montreal, Quebec, H4N 2W2, Canada

  • Advanced Clinical Research, LLC

    Bayamón, 00959, Puerto Rico

  • Aggarwal and Associates Limited

    Brampton, Ontario, L6T 0G1, Canada

  • Alberta Diabetes Institute

    Edmonton, Alberta, T6G 2E1, Canada

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma, 73069, United States

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan, 48098, United States

  • Arrow Clinical Trials

    Daytona Beach, Florida, 32117, United States

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario, N7T 4X3, Canada

  • Brigham and Women's Hospital Diabetes Program

    Boston, Massachusetts, 02115, United States

  • CARE - Centro de Alergia y Enfermedades Respiratorias

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1414, Argentina

  • CEMEDIAB

    C.a.b.a., Buenos Aires F.D., C1205AAO, Argentina

  • CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

    Godoy Cruz, Mendoza Province, 5501, Argentina

  • CIPREC

    Buenos Aires, Buenos Aires F.D., C1061AAS, Argentina

  • Cardiolink Clin Trials

    Monterrey, Nuevo León, 64060, Mexico

  • Central States Research

    Tulsa, Oklahoma, 74136, United States

  • Central Washington Health Services Association d/b/a Confluence Health

    Wenatchee, Washington, 98801, United States

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario, L6S 0C6, Canada

  • Centro Diabetológico Dr. Waitman

    Córdoba, 5000, Argentina

  • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

    Mexico City, Mexico City, 11650, Mexico

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Buenos Aires, Buenos Aires F.D., C1425AGC, Argentina

  • Centro Medico Privado San Vicente Diabetes

    Córdoba, Córdoba Province, 5006, Argentina

  • Centro Médico Viamonte

    Buenos Aires, Buenos Aires F.D., C1120AAC, Argentina

  • Centro de Investigaciones Clínicas Baigorria

    Granadero Baigorria, Santa Fe Province, 2152, Argentina

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI, Argentina

  • Clinical Research of Central Florida

    Winter Haven, Florida, 33880, United States

  • Clínica García Flores SC

    Monterrey, Nuevo León, 64610, Mexico

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231, United States

  • Deaconess Clinic - Gateway Health Center

    Newburgh, Indiana, 47630, United States

  • Diseno y Planeacion en Investigacion Medica

    Guadalajara, Jalisco, 44130, Mexico

  • Enclifar Ensayos Clínicos Farmacológicos Sc

    Chihuahua City, 31110, Mexico

  • Fundación Respirar

    Buenos Aires, C1426ABP, Argentina

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, 00917, Puerto Rico

  • Hamilton Medical Research Group

    Hamilton, Ontario, L8L5G4, Canada

  • Herman Clinical Research

    Suwanee, Georgia, 30024, United States

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 66460, Mexico

  • Hospital de Jésus, I.A.P.

    Mexico City, Mexico City, 06090, Mexico

  • IMA Clinical Research Monroe - Armand

    Monroe, Louisiana, 71201, United States

  • IMA Clinical Research West Virginia

    Morgantown, West Virginia, 26505, United States

  • Instituto Centenario

    CABA, Buenos Aires F.D., 1204, Argentina

  • Instituto Veracruzano en Investigación Clínica S.C.

    Veracruz, 91851, Mexico

  • Instituto de Diabetes, Obesidad y Nutricion

    Cuernavaca, Morelos, 62250, Mexico

  • Instituto de Investigaciones Clinicas Rosario

    Rosario, Santa Fe Province, S2000CVD, Argentina

  • Juno Research

    Houston, Texas, 77040, United States

  • Long Beach Research Institute

    Long Beach, California, 90805, United States

  • Maple Leaf Research

    Toronto, Ontario, M5G 1K2, Canada

  • Mautalen Salud e Investigación

    Buenos Aires, Buenos Aires F.D., C1128AAF, Argentina

  • MedStar Health Research Institute (MedStar Physician Based Research Network)

    Hyattsville, Maryland, 20782, United States

  • Medication Management

    Greensboro, North Carolina, 27405, United States

  • Medrasa Clinical Research

    Wylie, Texas, 75098, United States

  • NECCR PrimaCare Research

    Fall River, Massachusetts, 02721, United States

  • NYC Research INC

    Long Island City, New York, 11106, United States

  • Neighborhood Healthcare Institute of Health

    Escondido, California, 92025, United States

  • New Age Medical Research Corporation

    Miami, Florida, 33186, United States

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189, United States

  • Pacific Diabetes & Endocrine Center

    Honolulu, Hawaii, 96817, United States

  • Palm Research Center Sunset

    Las Vegas, Nevada, 89148, United States

  • Palm Research Center Tenaya

    Las Vegas, Nevada, 89128, United States

  • Prime Health Clinical Research

    Toronto, Ontario, M4S 1Y2, Canada

  • Private Practice - Dr. Nigel Jagan

    Whitby, Ontario, L1N 2L1, Canada

  • RM Pharma Specialists

    Mexico City, Mexico City, 03100, Mexico

  • Rancho Cucamonga Clinical Research

    Rancho Cucamonga, California, 91730, United States

  • Remington Davis Clinical Research

    Columbus, Ohio, 43215, United States

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho, 83404, United States

  • South Broward Research

    Miramar, Florida, 33027, United States

  • Southern Endocrinology Associates

    Mesquite, Texas, 75149, United States

  • Stat Research S.A.

    Buenos Aires, Buenos Aires F.D., C1023AAB, Argentina

  • Texas Valley Clinical Research

    Weslaco, Texas, 78596, United States

  • The Corvallis Clinic, P.C.

    Corvallis, Oregon, 97330, United States

  • The Wharton Medical Clinic Clinical Trials Inc

    Hamilton, Ontario, L8L 5G8, Canada

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • University of Alabama - Department of Nutrition Sciences

    Birmingham, Alabama, 35294, United States

  • University of Calgary - Clinical Trials Unit

    Calgary, Alberta, T2T 5C7, Canada

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325, United States

  • Valley Institute of Research - Fort Worth

    Fort Worth, Texas, 76164, United States

  • Velocity Clinical Research, Dallas

    Dallas, Texas, 75230, United States

  • Winterberry Research Inc.

    Hamilton, Ontario, L8J 0B6, Canada

More trials for these conditions

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