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New combo drug CagriSema takes on tirzepatide in diabetes showdown

NCT ID NCT06534411

Disease control Sponsor: Novo Nordisk A/S 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 3 times

Summary

This study tests a new investigational medicine called CagriSema against an approved drug, tirzepatide, in people with type 2 diabetes whose blood sugar is not well controlled by current pills. About 1,023 adults will receive either CagriSema or tirzepatide once a week for up to 1 year and 4 months. The main goals are to see how much each treatment lowers blood sugar and body weight.

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

1,023 people

The number who actually took part.

Started

Nov 2024

Finished

Jul 2026

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: * Male or female (sex at birth). * Age 18 years or above at the time of signing the informed consent. * Diagnosed with type 2 diabetes mellitus greater than or equal to (\>=) 180 days before screening. * Stable daily dose(s) \>= 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: * Metformin * sodium-glucose co-transporter 2 inhibitor (SGLT2i) * Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mol \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening. * Body mass index (BMI) \>= 30 kilogram per square meter (kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening. Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. * Renal impairment with estimated Glomerular Filtration Rate less than \< 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening. * Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days is allowed. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

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Conditions

The condition(s) this trial relates to.

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

  • "Laiko" General Hospital of Athens

    Goudi/Athens, 11527, Greece

  • 'Ippokrateio' General Hospital of Thessaloniki

    Thessaloniki, 54642, Greece

  • AES Minneapolis DRS

    Richfield, Minnesota, 55423, United States

  • AES St. Louis DRS

    St Louis, Missouri, 63141, United States

  • AES Tucson DRS

    Tucson, Arizona, 85712, United States

  • AGA Clinical Trial

    Hialeah, Florida, 33012, United States

  • AIG Hospitals,Hyderabad

    Hyderabad, Telangana, 500032, India

  • Acharya Vinoba Bhave Rural Hospital, Sawangi Meghe, Wardha

    Wardha, Maharashtra, 442001, India

  • Aeres Clinical Research

    Laredo, Texas, 78041, United States

  • Albany Medical College

    Albany, New York, 12203, United States

  • Alexandra General Hospital, Therapeutic Clinic

    Athens, Attica, 11528, Greece

  • All India Institute of Medical Sciences (AIIMS)

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Alpha Recherche Clinique - Clinique de Levis

    Lévis, Quebec, G6V 0C9, Canada

  • Arthur Asirvatham hospital,

    Madurai, Tamil Nadu, 625 020, India

  • Austrials

    St Leonards, New South Wales, 2065, Australia

  • Bioclinical Research Alliance

    Miami, Florida, 33155, United States

  • Biopharma Informatic, LLC

    McAllen, Texas, 78503, United States

  • CMI Dr Pop Lavinia

    Baia Mare, Maramureş, 430222, Romania

  • CPQuali Pesquisa Clínica Ltda

    São Paulo, São Paulo, 01228-000, Brazil

  • Cahaba Research

    Pelham, Alabama, 35124, United States

  • Carteret Medical Group

    Morehead City, North Carolina, 28557, United States

  • Center for Diab,Obes & Metab

    Pembroke Pines, Florida, 33024, United States

  • Centre Medical Acadie

    Montreal, Quebec, H4N 2W2, Canada

  • Centre de Recherche Saint-Louis

    Québec, G1W 4R4, Canada

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario, L6S 0C6, Canada

  • Centricity Research Etobicoke Endocrinology

    Etobicoke, Ontario, M9R 4E1, Canada

  • Centro Médico CIMEL

    Lanús Este, Buenos Aires, B1824KAJ, Argentina

  • Centro Periferico De Especialidades Bola Azul

    Almería, 04009, Spain

  • Centro de Diabetes Curitiba

    Curitiba, Paraná, 80810-040, Brazil

  • Centro de Investigaciones Metabólicas

    City of Buenos Aires, C1056ABI, Argentina

  • Centro de Investigaciones Médicas Mar del Plata

    Mar del Plata, Buenos Aires, B7600GNY, Argentina

  • Centro de Investigaciones Médicas Tucumán

    San Miguel de Tucuimán, Tucumán Province, 4000, Argentina

  • Centrum Medyczne Oporow

    Wroclaw, 52-416, Poland

  • Centrum Terapii Wspolczesnej - J.M. Jasnorzewska S.K.A.

    Lodz, Łódź Voivodeship, 90-338, Poland

  • Chang Gung Memorial Hospital - Kaohsiung Branch

    Kaohsiung City, 833, Taiwan

  • Chang Gung Memorial Hospital Linkou

    Taoyuan City, 333, Taiwan

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333, Taiwan

  • China Medical University Hospital

    Taichung, 404328, Taiwan

  • China Medical University Hospital

    Taichung, 404, Taiwan

  • Chrysalis Clinical Research

    St. George, Utah, 84790, United States

  • Circuit Clinical - PMSI

    Pottstown, Pennsylvania, 19464, United States

  • Clalit sick fund Herzeliya

    Herzeliya, Israel, 4630945, Israel

  • ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.

    Budapest, 1089, Hungary

  • Clinica Korall S.R.L. Satu Mare

    Satu Mare, 440055, Romania

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008, Spain

  • Clinical Invest Special_Gurnee

    Gurnee, Illinois, 60031, United States

  • Clinical Res Collaborative

    Cumberland, Rhode Island, 02864, United States

  • Clinical Research Associates

    Nashville, Tennessee, 37203, United States

  • Clínica Nuevas Tecnologías en Diabetes y Endocrinología

    Seville, 41003, Spain

  • Cotton-Oneill Diabetes and End

    Topeka, Kansas, 66606-2806, United States

  • Ctr de Med Metab de Lanaudiere

    Terrebonne, Quebec, J6X 4P7, Canada

  • Ctr de recherche Clinique de Laval

    Laval, Quebec, H7T 2P5, Canada

  • Desert Oasis Healthcare

    Palm Springs, California, 92262, United States

  • Diab Serwis Popenda Spółka Jawna

    Chorzów, 41-516, Poland

  • Diabdana S.R.L.

    Oradea, Bihor County, 410147, Romania

  • Diabet Med SRL

    Bucharest, 050913, Romania

  • Diabetes & Endocrine Specialists - La Mesa

    La Mesa, California, 91942, United States

  • Diabetes Heart Research Centre

    Toronto, Ontario, M6G 1M2, Canada

  • Diabetes, Thyroid and Endocrine Centre

    Jaipur, Rajasthan, 302006, India

  • Diex Recherche Victoriaville

    Victoriaville, Quebec, G6P 3Z8, Canada

  • Endolife Specialty Hospitals

    Guntur, Andhra Pradesh, 522001, India

  • Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.

    Olsztyn, 10-117, Poland

  • Evangelismos Hospital

    Athens, 10676, Greece

  • Excel Endocrine Centre

    Kolhāpur, Maharashtra, 416008, India

  • FEME Medical LLC

    Washington D.C., District of Columbia, 20010, United States

  • Fundación CESIM

    Santa Rosa, La Pampa Province, 6300, Argentina

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick, E1G 1A7, Canada

  • General Hospital Venizeleio-Pananeio - Diabetic Clinic

    Heraklion, Crete, 71409, Greece

  • General Hospital of Thessaloniki 'G. Gennimatas

    Thessaloniki, 54635, Greece

  • Hadassah Ein Karam MC - Diabetes Unit

    Jerusalem, 91120, Israel

  • Herz- und Diabeteszentrum NRW - Bad Oeynhausen

    Bad Oeynhausen, 32545, Germany

  • Hilltop Medical Clinic

    Surrey, British Columbia, V4A 0C1, Canada

  • Holston Medical Group

    Kingsport, Tennessee, 37660, United States

  • Hospital Clínico de Valladolid

    Valladolid, 47003, Spain

  • Hospital Universitario San Cecilio

    Granada, 18016, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Hunter Diabetes Centre

    Merewether, New South Wales, 2291, Australia

  • IMOBA

    City of Buenos Aires, C1056ABH, Argentina

  • IPGME&R and SSKM Hospital

    Kolkata, West Bengal, 700020, India

  • Iatriko Athinon 'Palaiou Falirou'

    Athens, 17562, Greece

  • Instituto de Investigaciones Clinicas San Nicolás

    San Nicolás, B2900, Argentina

  • Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila

    Bucharest, Bucharest, 020475, Romania

  • Iowa Diabetes & Endo Res Ctr

    West Des Moines, Iowa, 50266, United States

  • J.Lewis Research Inc

    Salt Lake City, Utah, 84109, United States

  • JCCT- Juno NW Houston

    Houston, Texas, 77040, United States

  • Javara Inc. / Privia Medical Group Georgia LLC

    Fayetteville, Georgia, 30214, United States

  • Jawahar Lal Nehru Govt. Medical College

    Ajmer, Rajasthan, 305001, India

  • Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

    Puducherry, Tamil Nadu, 605006, India

  • John Muir Physicians Network

    Concord, California, 94520, United States

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaoshiung, 807, Taiwan

  • Kiepury Clinic MALGORZATA JARNOT SPECJALISTYCZNA PRAKTYKA GINEKOLOGICZNO-POLOZNICZA

    Sosnowiec, 41-209, Poland

  • Komáromi Selye János Kórház

    Komárom, Komárom-Esztergom, 2900, Hungary

  • Lillestol Research LLC

    Fargo, North Dakota, 58104, United States

  • London Road Diagnostic Clinic and Medical Centre

    Sarnia, Ontario, N7T 4X3, Canada

  • MED-TIMA Kft.

    Budapest, 1132, Hungary

  • MedicalCenter am Clemenshospital - Schwerpunktpraxis für Diabetologie und Ernährungsmedizin

    Münster, 48153, Germany

  • Medicover Neuroendokrinologie MVZ München

    München, 81667, Germany

  • Momentum Clinical Research St Leonards

    St Leonards, New South Wales, 2065, Australia

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • New Horizon Research Center

    Miami, Florida, 33165, United States

  • Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.

    Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

  • Optimal Research Sites

    Orange City, Florida, 32763, United States

  • Optumcare Clinical Trials,LLC-Golden

    Colorado Springs, Colorado, 80906, United States

  • PVN Kutató Kft.

    Budapest, 1102, Hungary

  • Paratus Clinical

    Bruce, Australian Capital Territory, 2617, Australia

  • Paratus Clinical

    Herston, Queensland, 4006, Australia

  • Piedmont Healthcare/Research

    Statesville, North Carolina, 28625, United States

  • PlanIt Research, PLLC

    Houston, Texas, 77079, United States

  • Praxis am Markt Dr. Becker

    Essen, 45355, Germany

  • Privia Health Javara Clin Res.

    Stephenville, Texas, 76401, United States

  • QUALICLINIC Egészségügyi Szolgáltató és Kutatásszervező Kft

    Budapest, Pest County, 1134, Hungary

  • Rabin MC Beilinson - Endo unit

    Petah Tikva, 49100, Israel

  • Ramaiah Memorial Hospital

    Bengaluru, Karnataka, 560054, India

  • Rambam MC - Diabetes and obesity center of excellence

    Haifa, 31096, Israel

  • Roger Chih Yu Chen

    Sydney, New South Wales, 2148, Australia

  • SC Nutrilife SRL

    Bucharest, 013764, Romania

  • SMS Hospital

    Jaipur, Rajasthan, 302004, India

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko

    Zabrze, 41-800, Poland

  • Sanamed Hospital SRL

    Bucharest, 060013, Romania

  • Sante Clinical Research

    Kerrville, Texas, 78028, United States

  • Sc Mediab Srl

    Târgu Mureş, Mureș County, 540142, Romania

  • Semmelweis Egyetem

    Budapest, 1083, Hungary

  • Sheba MC - Endocrinology Clinic

    Tel Litwinsky, 52621, Israel

  • Sourasky MC - Institute of Endocrinology, metabolism and hypertension

    Tel Aviv, 6423906, Israel

  • South Broward Research LLC

    Miramar, Florida, 33027, United States

  • Specjalistyczny Gabinet Diabetologiczny Rumianowski Radosław

    Gorzów Wielkopolski, 66-400, Poland

  • Synergy Groups Medical

    Houston, Texas, 77061, United States

  • Synexus Clin Res Dallas

    Dallas, Texas, 75234, United States

  • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

    Szeged, Csongrád-Csanád, 6725, Hungary

  • Szőcs Depot Egészségügyi Szolgáltató Kft.

    Budapest, 1042, Hungary

  • TPMG Clinical Research

    Newport News, Virginia, 23606, United States

  • Taichung Veterans General Hospital

    Taichung, 407, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 112, Taiwan

  • Tampa Bay Medical Research

    Clearwater, Florida, 33761, United States

  • Townsville University Hospital

    Douglas, Queensland, 4814, Australia

  • Triad Research Institute

    Norman, Oklahoma, 73072, United States

  • UT Southwestern Med Center

    Dallas, Texas, 75390, United States

  • Udyaan Health Care

    Lucknow, Uttar Pradesh, 226002, India

  • Univ of Nebraska Medical CTR

    Omaha, Nebraska, 68198-3020, United States

  • University General Hospital of Ioannina,Internal Medicine

    Ioannina, 45500, Greece

  • Universitätsklinikum Essen - Klinik für Endokrinologie, Diabetologie und Stoffwechsel

    Essen, 45147, Germany

  • Universitätsklinikum Freiburg - Innere Medizin II

    Freiburg im Breisgau, 79106, Germany

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, Podlaskie Voivodeship, 15-276, Poland

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-269, Poland

  • Velocity Clin Res - Panorama

    Van Nuys, California, 91405, United States

  • Velocity Clin Res Albuquerque

    Albuquerque, New Mexico, 87107, United States

  • Velocity Clin Res Austin

    Austin, Texas, 78759, United States

  • Velocity Clin Res Gaffney

    Gaffney, South Carolina, 29340, United States

  • Velocity Clin Res Gulfport

    Gulfport, Mississippi, 39503, United States

  • Velocity Clin Res Providence

    East Greenwich, Rhode Island, 02818, United States

  • Velocity Clin Res Santa Ana

    Santa Ana, California, 92704, United States

  • Velocity Clin Res-Chula Vista

    Chula Vista, California, 91911, United States

  • Velocity Clin Research LA

    Los Angeles, California, 90017, United States

  • Velocity Clinical Research-Phoenix

    Phoenix, Arizona, 85006, United States

  • Wendisch - Dahl Hamburg - DZHW

    Hamburg, 22607, Germany

  • West Orange Endocrinology

    Ocoee, Florida, 34761, United States

  • Wharton Medical Clinic Clinical Trials (Hamilton)

    Hamilton, Ontario, L8L 5G8, Canada

  • Wolfson MC - Diabetes Clinic

    Holon, 58100, Israel

  • Woodland Int. Research Group

    Little Rock, Arkansas, 72211, United States

  • Zentrum für klinische Studien Allgäu Oberschwaben

    Wangen, 88239, Germany

  • Észak-Pesti Centrumkórház Honvédkórház - Diabetológia Szakrendelés

    Budapest, 1134, Hungary

  • Óbudai Egészségügyi Centrum

    Budapest, Pest County, 1036, Hungary

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