AzTrials
AzTrials

Type 2 Diabetes MellitusPhase 3REIMAGINE 2NCT06065540

A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

A Phase 3 study testing Cagrilintide and Semaglutide in people with Type 2 Diabetes Mellitus, run by Novo Nordisk A/S at 405 sites in 32 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Cagrilintide and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,734 participants
Where
405 sitesin 32 countries
Study dates
27 Sep 2023to 6 Jan 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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) greater than or equal to 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 with or without Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors.
  • Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening.
  • Body Mass Index (BMI) greater than or equal to 25 kilogram per square metre ( kg/m^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.

Who cannot join

  • Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square metre (mL/min/1.73 m^2) as determined by central laboratory at screening.
  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are 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.

Trial locations and contacts

405 sites in 32 countries.

405 sites in 32 countries

United States100 sites

  • Synexus Clinical Research US, Inc

    Akron, Ohio, 44311

  • AMC Community Endocrinology

    Albany, New York, 12203

  • Velocity Clin Res Albuquerque

    Albuquerque, New Mexico, 87107

  • AnMed Health IMA

    Anderson, South Carolina, 29621

  • Synexus Clin Res US-Anderson

    Anderson, South Carolina, 29621

  • Velocity Clinical Res-Anderson

    Anderson, South Carolina, 29621

  • Arlington Family Res. Ctr Inc

    Arlington, Texas, 76012-4637

  • Velocity Clin Res Austin

    Austin, Texas, 78759

  • Velocity Clinical Res-Banning

    Banning, California, 92220

  • UT Health University of Texas

    Bellaire, Texas, 77401

  • Synexus Clin Res-Birmingham

    Birmingham, Alabama, 35211

  • Univ of Alabama_Birmingham

    Birmingham, Alabama, 35294

  • St. Luke's Health System

    Boise, Idaho, 83702

  • Holston Medical Group Pc

    Bristol, Tennessee, 37620-7352

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • Diabetes & Endo Specialists Inc

    Chesterfield, Missouri, 63017

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • Velocity Clin Res-Chula Vista

    Chula Vista, California, 91911

  • Optumcare Clinical Trials,LLC-Golden

    Colorado Springs, Colorado, 80906

  • Centricity Research

    Columbus, Ohio, 43213

  • John Muir Physicians Network

    Concord, California, 94520

  • Hope Clin Res & Wellness

    Conyers, Georgia, 30094

  • Clinical Res Collaborative

    Cumberland, Rhode Island, 02864

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230

  • North Texas Endocrine Center

    Dallas, Texas, 75231

  • Synexus Clin Res Dallas

    Dallas, Texas, 75234

  • Cedar Health Research

    Dallas, Texas, 75251

  • Velocity Clin Res Providence

    East Greenwich, Rhode Island, 02818

  • Velocity Clin Res Syracuse

    East Syracuse, New York, 13057

  • Headlands Research California, LLC

    Escondido, California, 92025

  • Velocity Clin Res Gaffney

    Gaffney, South Carolina, 29340

  • Velocity Clin Res Gardena

    Gardena, California, 90247

  • St. Vincent Hosp-Prevea Health

    Green Bay, Wisconsin, 54303

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina, 27408

  • Velocity Clin Res Gulfport

    Gulfport, Mississippi, 39503

  • Clinical Invest Special_Gurnee

    Gurnee, Illinois, 60031

  • Pacific Diabetes & Endo Ctr

    Honolulu, Hawaii, 96813

  • JCCT- Juno NW Houston

    Houston, Texas, 77040

  • Synergy Groups Medical

    Houston, Texas, 77061

  • PlanIt Research, PLLC

    Houston, Texas, 77079

  • Northeast Research Institute

    Jacksonville, Florida, 32204

  • Medical Colleagues-Texas LLP

    Katy, Texas, 77450

  • Sante Clinical Research

    Kerrville, Texas, 78028

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Velocity Clin Res San Diego

    La Mesa, California, 91942

  • Velocity Clin Res Lafayette

    Lafayette, Louisiana, 70508

  • Arkansas Clinical Research

    Little Rock, Arkansas, 72205

  • Loma Linda Univ Hlth Cr Endo

    Loma Linda, California, 92354

  • East Coast Institute for Res

    Macon, Georgia, 31210

  • Urban Family Practice Assoc

    Marietta, Georgia, 30067

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • Clinical Trial Services Corp

    Miami, Florida, 33144

  • Bioclinical Research Alliance

    Miami, Florida, 33155

  • New Horizon Research Center

    Miami, Florida, 33165

  • South Broward Research LLC

    Miramar, Florida, 33027

  • Facey Medical Foundation

    Mission Hills, California, 91345

  • Discovery MM Services, INC Missouri

    Missouri City, Texas, 77459

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Clinical Research Associates

    Nashville, Tennessee, 37203

  • BTC of New Bedford, LLC

    New Bedford, Massachusetts, 02740

  • TPMG Clinical Research

    Newport News, Virginia, 23606

  • Alliance for Multispec Res

    Newton, Kansas, 67114

  • Alliance for Multispec Res

    Norman, Oklahoma, 73069

  • West Orange Endocrinology

    Ocoee, Florida, 34761

  • Optimal Research Sites

    Orange City, Florida, 32763

  • Advent Health-Res Inst

    Orlando, Florida, 32804

  • AdventHealth Diab Inst

    Orlando, Florida, 32804

  • Synexus Clin Res - Orlando

    Orlando, Florida, 32806

  • Oviedo Medical Research, LLC

    Oviedo, Florida, 32765

  • Desert Oasis Hlthcr Med Group

    Palm Springs, California, 92262

  • Cahaba Research

    Pelham, Alabama, 35124

  • Velocity Clinical Research-Phoenix

    Phoenix, Arizona, 85006

  • Synexus Rsch /Cnt Phnx Med C

    Phoenix, Arizona, 85020

  • Rainier Clin Res Ctr Inc

    Renton, Washington, 98057

  • Endocrine Research Solutions, Inc.

    Roswell, Georgia, 30076

  • Endocrine Research Solutions

    Roswell, Georgia, 30076

  • AES San Antonio

    San Antonio, Texas, 78229

  • University of Texas San Antonio

    San Antonio, Texas, 78229

  • NE Clin Res of San Antonio

    San Antonio, Texas, 78233

  • Velocity Clin Res- San Bern

    San Bernardino, California, 92408

  • Linda Vista Health Care Ctr

    San Diego, California, 92111

  • Diabetes & Endo Treatment Spec

    Sandy City, Utah, 84093

  • Velocity Clin Res Santa Ana

    Santa Ana, California, 92704

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Hillcrest Clinical Research

    Simpsonville, South Carolina, 29681-1538

  • Endeavor Health

    Skokie, Illinois, 60077

  • Evanston Premier Hlthcr Res

    Skokie, Illinois, 60077

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Velocity Clin Res Spartanburg

    Spartanburg, South Carolina, 29303

  • Piedmont Healthcare/Research

    Statesville, North Carolina, 28625

  • Premier Medical Center, Inc.

    Toluca Lake, California, 91602

  • DM Clin Rsrch/Fam Diag Clinic

    Tomball, Texas, 77375

  • Cotton-O'Neil Diab & Endo Ctr

    Topeka, Kansas, 66606

  • Premier Research Inc.

    Trenton, New Jersey, 08611

  • Velocity Clin Res - Panorama

    Van Nuys, California, 91405

  • Iowa Diabetes & Endo Res Ctr

    West Des Moines, Iowa, 50266

  • Velocity Clin Res-Salt Lk City

    West Jordan, Utah, 84088

  • Southgate Medical Group, LLP

    West Seneca, New York, 14224

  • Great Lakes Medical Research

    Westfield, New York, 14787

  • Accellacare

    Wilmington, North Carolina, 28401

Other trials in United States

Canada31 sites

  • Centricity Res. Barrie Endo

    Barrie, Ontario, L4N 7L3

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario, L6S 0C6

  • Centricity Research Calgary Endocrinology

    Calgary, Alberta, T2H 2G4

  • Centricity Research Calgary

    Calgary, Alberta, T2H 2G4

  • Centricity Research Vaughn Endocrinology

    Concord, Ontario, L4K 4M2

  • Medical Trust Clinics, Inc.

    Courtice, Ontario, L1E2J5

  • Centricity Research Etobicoke Endocrinology

    Etobicoke, Ontario, M9R 4E1

  • Milestone Research

    London, Ontario, N5W 6A2

  • Western Univ. Cnt for Studies in Fam Med

    London, Ontario, N6G 2M1

  • My Endo Diabetes & Endo Cent

    Markham, Ontario, L3P 7P2

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick, E1G 1A7

  • Centre Medical Acadie

    Montreal, Quebec, H4N 2W2

  • Centricity Research Ottawa LMC

    Nepean, Ontario, K2J 0V2

  • Centricity Research Oshawa

    Oshawa, Ontario, L1J 2K9

  • Centricity Res Pointe-Claire

    Pointe-Claire, Quebec, H9R 4S3

  • ALPHA Recherche Clinique

    Québec, Quebec, G3K 2P8

  • Diex Recherche Quebec

    Québec, G1V 4T3

  • Clinique des Maladies Lipidiques de Quebec Inc.

    Québec, G1V 4W2

  • Centre de Recherche Saint-Louis

    Québec, G1W 4R4

  • LMC Clin Rsrch Inc. (Montreal)

    Saint-Laurent, Quebec, H4T 1Z9

  • Q & T Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1J 2G2

  • Synergy Wellness Clinic

    Sherwood Park, Alberta, T8H 0N2

  • Guilford Med Clinic

    Surrey, British Columbia, V3R 4H6

  • TLC Diabetes and Endocrinology

    Surrey, British Columbia, V3T0X6

  • Ocean West Research Clinic

    Surrey, British Columbia, V3Z 2N6

  • Hilltop Medical Clinic

    Surrey, British Columbia, V4A 0C1

  • Ctr de Med Metab de Lanaudiere

    Terrebonne, Quebec, J6X 4P7

  • Centricity Research Toronto

    Toronto, Ontario, M4G 3E8

  • Diabetes Heart Research Centre

    Toronto, Ontario, M6G 1M2

  • Spectrum Health Clinic

    Vancouver, British Columbia, V6Z 2T1

  • Diex Recherche Victoriaville

    Victoriaville, Quebec, G6P 3Z8

Other trials in Canada

Poland20 sites

  • Osteo Medic s.c. Artur Racewicz Jerzy Supronik

    Bialystok, Podlaskie Voivodeship, 15-351

  • NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska

    Bialystok, Podlaskie Voivodeship, 15-435

  • Centrum Medyczne Pratia Bydgoszcz

    Bydgoszcz, 85-796

  • Malopolskie Centrum Sercowo-Naczyniowe

    Chrzanów, Lesser Poland Voivodeship, 32-500

  • PAKS III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii

    Dąbrowa Górnicza, Silesian Voivodeship, 41-300

  • PAKS III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii

    Dąbrowa Górnicza, 41-300

  • Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski

    Gorzów Wielkopolski, Lubusz Voivodeship, 66-400

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika

    Lodz, Łódź Voivodeship, 93-513

  • Velocity Nova Sp. z o.o.

    Lublin, 20-362

  • KO-MED Centra Kliniczne Sp. z o.o.

    Puławy, 24-100

  • Centrum Medyczne Medyk Sp. z o.o.

    Rzeszów, Podkarpackie Voivodeship, 35-055

  • Velocity Nova Sp. z o.o.

    Staszów, 28-200

  • Velocity Nova Sp. z o.o.

    Staszów, Świętokrzyskie Voivodeship, 28-200

  • PAKS III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii

    Tychy, Silesian Voivodeship, 43-100

  • Instytut Diabetologii Sp. z o.o.

    Warsaw, Mazovian Voivodeship, 02-117

  • NBR Polska Tomasz Klodawski

    Warsaw, 00-710

  • Instytut Diabetologii Sp. z o.o.

    Warsaw, 02-117

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

    Warsaw, 02-507

  • Zgierskie Centrum Kardiologii Med-Pro Polsko-Amerykańskich Klinik Serca

    Zgierz, 95-100

  • Prywatna Praktyka Lekarska Anna Chudoba

    Żyrardów, Masovian Voivodeship, 96-300

Other trials in Poland

Turkey (Türkiye)20 sites

  • Cukurova Universitesi Tip Fakultesi

    Adana, 01790

  • Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi- Endokrinoloji

    Adana, 01790

  • Akdeniz University Tip Fakultesi Hastanesi

    Antalya, 07058

  • Akdeniz Üniversitesi Hastanesi- Endokrinoloji

    Antalya, 07058

  • Eskisehir Osmangazi University School of Medicine

    Eskişehir, 26040

  • Eskişehir Osmangazi Üniversitesi Sağlık, Uygulama ve Araştırma Hastanesi

    Eskişehir, 26040

  • Haseki Eğitim ve Araştırma Hastanesi- Dahiliye

    Istanbul, 34098

  • Haseki Sultangazi

    Istanbul, 34098

  • Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi

    Istanbul, 34371

  • Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi- Seyrantepe Yerleşkesi- Endokrinoloji

    Istanbul, 34371

  • Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji

    Istanbul, 34390

  • İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Endokrinoloji

    Istanbul, 34390

  • Basaksehir Cam ve Sakura Sehir Hastanesi

    Istanbul, 34480

  • Başakşehir Çam ve Sakura Şehir Hastanesi

    Istanbul, 34480

  • Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye

    Istanbul, 34722

  • T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital

    Istanbul, 34722

  • Recep Tayyip Erdoğan Üni. Eğitim ve Araştırma Hastanesi

    Rize, 53020

  • Recep Tayyip Erdoğan Üniversitesi EAH-Endokrinoloji

    Rize, 53020

  • Tekirdag Namık Kemal UTF

    Tekirdağ, 59030

  • Tekirdağ Namık Kemal Üniversitesi Hastanesi- Dahiliye

    Tekirdağ, 59030

Other trials in Turkey (Türkiye)

Germany15 sites

  • Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR

    Berlin, 13597

  • Diabetologische Schwerpunktpraxis Daaden

    Daaden, 57567

  • Diabeteszentrum-Do Dres. K U. Ch. Busch GbR

    Dortmund, 44137

  • Uniklinik TU Dresden - Med. Klinik III

    Dresden, 01307

  • Zentrum für klinische Studien Südbrandenburg GmbH

    Elsterwerda, 04910

  • InnoDiab Forschung GmbH

    Essen, 45136

  • MVZ Diabeteszentrum Dr. Tews GmbH

    Gelnhausen, 63571

  • Diabetes-Zentrum-Wilhelmsburg GbR

    Hamburg, 21109

  • Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR

    Hamburg, 22041

  • Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz

    Lingen, 49808

  • Uniklinik Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck

    Lübeck, 23538

  • Die Praxis am Ludwigsplatz

    Ludwigshafen, 67059

  • Medicover Neuroendokrinologie MVZ München

    München, 81667

  • RED-Institut für medizinische Forschung und Fortbildung GmbH

    Oldenburg in Holstein, 23758

  • Praxis für Innere Medizin - Zwenkau

    Zwenkau, 04442

Other trials in Germany

India15 sites

  • Swasthya Diabetes Care

    Ahmedabad, Gujarat, 390013

  • Lifecare Hospital and Research Centre

    Bengaluru, Karnataka, 560066

  • Post Graduate Institute of Medical Education & Research

    Chandigarh, 160012

  • Madras Diabetes Research Foundation

    Chennai, Tamil Nadu, 600086

  • KG Hospital

    Coimbatore, Tamil Nadu, 641018

  • Gauhati Medical College and Hospital

    Guwahati, Assam, 781032

  • Gleneagles Hospitals

    Hyderabad, Telangana, 500004

  • Dr P V Rao - Diabetes Research Centre

    Hyderabad, Telangana, 50082

  • SMS Medical College & Hospital

    Jaipur, Rajasthan, 302004

  • Apollo Multispeciality Hospital, Kolkata

    Kolkata, West Bengal, 700054

  • BYL Nair Hospital and T N Medical College Department of endo

    Mumbai, Maharashtra, 400008

  • K R Hospital

    Mysuru, Karnataka, 570001

  • Lady Hardinge Medical College

    New Delhi, 110001

  • Ashirwad Hospital and Research Centre

    Thane, Maharashtra, 421004

  • Yalamanchi Hospitals and Research centres pvt ltd

    Vijaywada, Andhra Pradesh, 520002

Other trials in India

Romania15 sites

  • CMI Dr. Pletea Noemi SRL

    Bacau, 600154

  • Mariodiab Clinic SRL

    Brasov, 500101

  • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed

    Brasov, 500283

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

    Bucharest, Bucurestii, 020475

  • Diabet Med SRL

    Bucharest, 050913

  • Spitalul Clinic Judetean Urgenta Cluj-Napoca

    Cluj-Napoca, Cluj, 400006

  • Urodiamed SRL

    Craiova, 200349

  • S.C Milena Sante SRL

    Galati, 800001

  • Gama Diamed Srl

    Mangalia, 905500

  • Bella Praxis S.R.L.

    Paşcani, 705200

  • Cabinet Medical Individual Dr. Ramona Dragut SRL

    Piteşti, Argeş, 110283

  • Diabmed Dr Popescu Alexandrina SRL

    Ploieşti, Prahova, 100179

  • CMI Dr. Busegeanu Mihaela Magdalena

    Ploieşti, Prahova, 100342

  • Poli Cardinal Med Srl

    Reghin, Mureș County, 545300

  • Cabinet Medical de Diabet, Nutritie si Boli Metabolice-Dr. Zaharie Daniela Gabriela

    Zalău, Sălaj County, 450112

Other trials in Romania

Italy14 sites

  • Azienda Sanitaria Usl Toscana Sud Est - Ospedale San Donato

    Arezzo, 52100

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

  • Azienda Ospedaliero-Universitaria Renato Dulbecco

    Catanzaro, 88100

  • Università degli studi G. D'Annunzio Chieti Pescara - CAST

    Chieti Scalo, 66100

  • AOU Careggi Firenze

    Florence, Fi, 50134

  • AOU Careggi Firenze

    Florence, Tuscany, 50134

  • Istituto Scientifico San Raffaele

    Milan, MI, 20132

  • Azienda Ospedaliera Luigi Sacco

    Milan, 20157

  • Azienda Ospedaliera Universitaria Federico II di Napoli

    Naples, 80131

  • AOUP Giaccone Palermo

    Palermo, 90127

  • Dip. di Medicina Interna Policlinico Universitario Palermo

    Palermo, 90127

  • Azienda Ospealiero Universitaria Policlinico Umberto I

    Roma, 00161

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di scienze Mediche e Chirurgiche

    Rome, 00168

  • Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento

    Verona, 37126

Other trials in Italy

Slovakia12 sites

  • DIADA, s.r.o.

    Bardejov, 08501

  • Diabetologicka ambulancia DIOLI s.r.o.

    Košice, 040 01

  • DIOLI s.r.o.

    Košice, 040 01

  • MediVet s.r.o.

    Malacky, 90101

  • DIALIPID, s.r.o.

    Prešov, 080 01

  • MUDr. Jan Culak, s.r.o.

    Prievidza, 971 01

  • DIACENTRUM, s.r.o.

    Ružomberok, 034 01

  • MEDI-DIA s.r.o.

    Sabinov, 083 01

  • MEDI-DIA s.r.o.

    Sabinov, 08301

  • DEImedi, s. r. o.

    Šurany, 942 01

  • ARETEUS s.r.o.

    Trebišov, 075 01

  • iDia s. r. o.

    Žiar nad Hronom, 965 01

Other trials in Slovakia

United Kingdom12 sites

  • Aberdeen Royal Infirmary - Diabetes

    Aberdeen, AB25 2ZP

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZP

  • Oldfield Surgery

    Bath, BA2 3HT

  • Oakenhurst Medical Practice

    Blackburn, BB2 1AX

  • Ninewells Hospital

    Dundee, DD1 9SY

  • Aintree University Hospital

    Liverpool, L9 7AL

  • Norfolk and Norwich University Hospital Trust

    Norwich, NR4 7UY

  • Pickering Medical Practice

    Pickering, North Yorkshire, YO18 8BL

  • Moorgreen Hospital

    Southampton, SO30 3JB

  • Lister Hospital

    Stevenage, Hertfordshire, SG1 4AB

  • Joint Clinical Research Facility - Swansea

    Swansea, SA2 8PP

  • Royal Cornwall Hospital (Treliske)

    Truro, TR1 3LJ

Other trials in United Kingdom

Greece11 sites

  • University Hospital of Athens ATTIKON

    Athens, Attica, 12462

  • Iatriko Psychicou Private Clinic

    Athens, 115 25

  • "Laiko" General Hospital of Athens

    Athens, 11527

  • General hospital of Athens 'G.Gennimatas'

    Athens, 11527

  • Iatriko Athinon (Athens Medical Canter)

    Athens, 15125

  • Univ Gen Hospital Larisa

    Larissa, 41110

  • General Hospital Of Thessaloniki Papageorgiou

    Nea Efkarpia, Thessaloniki, 56429

  • "AHEPA" University Hospital of Thessaloniki

    Thessaloniki, 54621

  • NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes

    Thessaloniki, 54635

  • "AHEPA" University Hospital of Thessaloniki

    Thessaloniki, 54636

  • "Ippokrateio" G.H. of Thessaloniki

    Thessaloniki, 54642

Other trials in Greece

Bulgaria10 sites

  • IPSMC - Dr. Nikolay Kostadinov EOOD

    Burgas, 8000

  • Dr. Tatyana Metalova - AIPSMCE EOOD

    Gotse Delchev, 2900

  • ASOMCEID - Individual Practice - Dr. Abdul-Azis EOOD

    Kardzhali, 6600

  • Medical Center Zdrave Lom EOOD

    Lom, 3600

  • Medical Centre Razgrad OOD

    Razgrad, 7200

  • DCC Ascendent OOD

    Sofia, 1202

  • Medical Center Maraya Med EOOD

    Sofia, 1756

  • Medical Centre - Clinic Nova EOOD

    Varna, 9000

  • Medical centre Clinic Nova

    Varna, 9000

  • UMHAT Sveta Marina EAD, Clinic of Internal Diseases

    Varna, 9010

Other trials in Bulgaria

Japan10 sites

  • Akaicho Clinic

    Chiba-shi, Chiba, 260-0804

  • Naka Kinen Clinic_Internal medicine

    Ibaraki, 311-0113

  • Naka Kinen Clinic

    Ibaraki, 311-0113

  • Seino Internal Medicine Clinic_Internal medicine

    Koriyama-shi, Fukushima, Fukushima, Japan, 963-8851

  • Minami Akatsuka Clinic_internal medicine

    Mito-shi, Ibaraki, 311-4153

  • Abe Diabetes Clinic_Internal Medicine

    Oita-shi, Oita,, Japan, 870 0039

  • Medical Research Institute KITANO HOSPITAL_Diabetes & Endocrinology

    Osaka-shi, Osaka, 530-8480

  • Tokyo-Eki Center-building Clinic_Internal Medicine

    Tokyo, 103-0027

  • Fukuwa Clinic_Internal Medicine

    Tokyo, 104-0031

  • Fukuwa Clinic

    Tokyo, 104-0031

Other trials in Japan

China9 sites

  • Beijing Friendship Hospital, Capital Medical University-Endocrinology

    Beijing, Beijing Municipality, 100050

  • Chinese People's Liberation Army General Hospital-Endocrinology

    Beijing, Beijing Municipality, 100853

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404000

  • Jinan Central Hospital

    Ji'Nan, Shandong, 250000

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • Huaihe Hospital of Henan University-Endocrinology

    Kaifeng, Henan, 475000

  • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

    Nanjing, Jiangsu, 210011

  • Suzhou Municipal Hospital-Endocrinology

    Suzhou, Jiangsu, 215002

  • The Affiliated Hospital of Jiangsu University-Endocrinology

    Zhenjiang, Jiangsu, 212001

Other trials in China

Hungary9 sites

  • Óbudai Egészségügyi Centrum

    Budapest, Pest County, 1036

  • Bajcsy-Zsilinszky Kórház

    Budapest, 1106

  • MH Egészségügyi Központ

    Budapest, 1134

  • Debreceni Egyetem Belgyógyászati Klinika

    Debrecen, Hajdú-Bihar, 4032

  • Kaposi Mór Oktató Kórház

    Kaposvár, 7400

  • Kanizsai Dorottya Kórház

    Nagykanizsa, 8800

  • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ

    Szeged, Csongrád-Csanád, 6725

  • Vas Vármegyei Markusovszky Egyetemi Oktatókórház

    Szombathely, 9700

  • Zala Megyei Szent Rafael Kórház

    Zalaegerszeg, 8900

Other trials in Hungary

Israel9 sites

  • Linn clinic - Clalit Health Services

    Haifa, 35152

  • Linn clinic - Diabetes Unit

    Haifa, 35152

  • Clalit sick fund Herzeliya

    Herzeliya, Israel, 4630945

  • Clalit sick fund Herzlia

    Herzliya, 4630945

  • Wolfson MC - Diabetes Clinic

    Holon, 58100

  • Hadassah Ein Karam MC - Diabetes Unit

    Jerusalem, 91120

  • Kaplan MC - Metabolic Unit

    Rehovot, 76100

  • Kaplan MC

    Rehovot, 76100

  • Sheba MC - Endocrinology Clinic

    Tel HaShomer, 52621

Other trials in Israel

Australia8 sites

  • Charles Perkins Centre

    Camperdown, New South Wales, 2050

  • Momentum Clinical Research Darlinghurst

    Darlinghurst, New South Wales, 2010

  • St Vincent's Hospital Melbourne - Endocrinology & Diabetes Department

    Fitzroy, Victoria, 3065

  • Macquarie University - Clinical Trials Unit

    Macquarie Park, New South Wales, 2109

  • Logan Hospital

    Meadowbrook, Queensland, 4131

  • Baker Heart and Diabetes Institute

    Melbourne, Victoria, 3004

  • Hunter Diabetes Centre

    Merewether, New South Wales, 2291

  • Southern Adelaide Diabetes & Endocrine Services

    Oaklands Park, South Australia, 5046

Other trials in Australia

Slovenia8 sites

  • Healthcare centre Kocevje

    Kočevje, 1330

  • Healthcare Centre Koper

    Koper, 6000

  • Dermatologija Bartenjev

    Ljubljana, 1000

  • UKC Ljubljana, Endocrinology and Diabetes

    Ljubljana, 1000

  • UKC Maribor - diabetes

    Maribor, 2000

  • Healthcare Centre Nova Gorica

    Nova Gorica, 5000

  • General Hospital Nova Gorica_Diabetes

    Sempeter pri Gorici, 5290

  • Hospital Topolšica

    Topolšica, 3326

Other trials in Slovenia

Spain8 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • ABS La Roca CAP Vicenç_Endocrino

    La Roca Del Vallés, Barcelona, 08430

  • Hospital Universitario de Móstoles

    Móstoles, 28935

  • Hospital Son Llatzer

    Palma de Mallorca, 07198

  • Hospital General de Segovia

    Segovia, 40002

  • H. Infanta Luisa_Endocrino y Obesidad

    Seville, 41010

  • Hospital La Fe - Endocrinología y Nutrición

    Valencia, 46026

Other trials in Spain

Czechia7 sites

  • Fakultní nemocnice U sv. Anny v Brně

    Brno, 602 00

  • Edumed Broumov

    Broumov, 550 01

  • Diahaza s.r.o.

    Holešov, 76901

  • DIALINE s.r.o.

    Plzeň 3, 301 00

  • IKEM Centrum Diabetologie

    Prague, Czech Republic, 140 21

  • Diabet2 s.r.o.

    Prague, 110 00

  • MUDr. Michala Pelikanova

    Prague, 140 00

Other trials in Czechia

South Korea7 sites

  • The Catholic University of Korea, Bucheon ST. Mary's Hospital

    Bucheon-si, Gyeonggi-do, 14647

  • Yeungnam University Medical Center

    Daegu, 42415

  • Chosun University Hospital

    Gwangju, 501-717

  • Kyunghee University Medical Center

    Seoul, 02447

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

Other trials in South Korea

Sweden7 sites

  • CTC EbbePark Linköping

    Linköping, 582 13

  • Clemenstorgets Hjärtmottagning

    Lund, 222 21

  • Skåne US - Endokrinologkliniken Lund

    Lund, 222 42

  • Skåne US - Forskningsmottagning Internmedicin (tidigare KFE)

    Malmö, 205 02

  • CTC GoCo Mölndal

    Mölndal, 431 53

  • Örebro US - Överviktsenheten

    Örebro, 701 85

  • KS Solna - FOU hjärta- kärl Mottagningen

    Stockholm, 171 64

Other trials in Sweden

Argentina6 sites

  • STAT Research

    Buenos Aires, C1023AAB

  • Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

    Buenos Aires, C1425AGC

  • Mautalen Salud e investigación

    CABA, Buenos Aires, C1128 AAF

  • Sanatorio Güemes

    CABA, City of Buenos Aires, C1180AAX

  • CIPREC Arenales

    CABA, C1061AAS.

  • Instituto de Investigaciones Clínicas Rosario

    Rosario, Santa Fe Province, S2000CUD

Other trials in Argentina

Croatia6 sites

  • Specijalna bolnica Thalassotherapia

    Opatija, 51 410

  • Poliklinika SLAVONIJA OSIJEK

    Osijek, County of Osijek-Baranja, 31000

  • Clinical Hospital Centre Rijeka_Endocrinology

    Rijeka, Primorje-Gorski Kotar County, 51 000

  • General Hospital Dr. Josip Bencevic_Diabetic department

    Slavonski Brod, 35 000

  • Opca bolnica Varazdin_Endocrinology

    Varaždin, 42 000

  • Poliklinika Solmed

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Denmark6 sites

  • Aarhus Universitetshospital, Steno Diabetes Center Aarhus

    Aarhus N, 8200

  • Bispebjerg Hospital, IC-Forskning

    Copenhagen, 2400

  • Steno Diabetes Center Copenhagen

    Herlev, 2730

  • Hillerød Endokrinologisk amb. H0652

    Hillerød, 3400

  • Hvidovre Hospital Endokrinologisk forsk. afs. 159

    Hvidovre, 2650

  • Steno Diabetes Center Odense

    Odense C, 5000

Other trials in Denmark

Serbia6 sites

  • CHC Zvezdara, Clinical department for endocrinology

    Belgrade, 11000

  • Endocrinology, Diabetes and Metabolism Diseases Clinic

    Belgrade, 11000

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11080

  • Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department

    Kragujevac, 34000

  • Clinical Centre Kragujevac, Internal Diseases Clinic, Endocr

    Kragujevac, 34000

  • Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

South Africa6 sites

  • Newtown Clinical Research

    Johannesburg, Gauteng, 2001

  • Sandton Medical Research

    Johannesburg, Gauteng, 2196

  • Clinresco Centres (Pty) Ltd

    Kempton Park, Gauteng, 1619

  • Paarl Research Centre

    Paarl, Cape Town, Western Cape, 7646

  • Phoenix Pharma

    Port Elizabeth, Eastern Cape, 6001

  • Clinical Trial Systems (CTC)

    Pretoria, Gauteng, 0186

Other trials in South Africa

Finland5 sites

  • Terveystalo Jyväskylä

    Jyväskylä, 40100

  • Seinäjoen keskussairaala

    Seinäjoki, 60220

  • Pihlajalinna Koskiklinikka

    Tampere, 33100

  • Terveystalo Tampere Rautatienkatu

    Tampere, 33100

  • Turku University Hospital

    Turku, 20520

Other trials in Finland

Colombia4 sites

  • Cimedical

    Barranquilla, 80001

  • Clinica Imbanco SAS

    Cali, 760042

  • FOSCAL

    Floridablanca, Santander Department, 681004

  • IMAT - Oncomedica

    Montería, 230001

Other trials in Colombia

Mexico4 sites

  • Centro de Estudios de Investigación Metabólicos y Cardio

    Ciudad Madero, Tamaulipas, 89440

  • Instituto Jalisciense de Investigación en Diabetes y Obesidad

    Guadalajara, Jalisco, 44600

  • Centro de Investigacion Clinica Endocrinologica de Jalisco

    Guadalajara, Jalisco, 44670

  • Centro de investigación en Artritis y Osteoporosis S.C.

    Mexicali, Estado de Baja California, 21200

Other trials in Mexico

Brazil3 sites

  • Cline Research Center

    Curitiba, Paraná, 80030-480

  • CPQuali Pesquisa Clínica Ltda

    São Paulo, São Paulo, 01228-000

  • CPCLIN - Centro de Pesquisas Clínicas

    São Paulo, São Paulo, 01228-200

Other trials in Brazil

Taiwan2 sites

  • Changhua Christian Hospital_Metabolic Dept.

    Changhua, 500

  • Taipei Medical University Hospital

    Taipei, 110

Other trials in Taiwan

About this study

Official title: Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4/2.4 mg and 1.0/1.0 mg Once Weekly Versus Semaglutide 2.4 mg and 1.0 mg, Cagrilintide 2.4 mg and Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor

The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).

Being tested
Cagrilintide, Semaglutide, Placebo cagrilintide, Placebo semaglutide
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CagrilintideDrug

    Participants will receive once-weekly s.c injection of cagrilintide at escalating doses every week until maintenance dose 1 and dose 2 of cagrilintide is reached.

  • SemaglutideDrug

    Participants will receive once-weekly s.c injection of semaglutide at escalating doses every week until maintenance dose 1 and dose 2 of semaglutide is reached.

  • Placebo cagrilintideDrug

    Participants will receive placebo matched to cagrilintide subcutaneously.

  • Placebo semaglutideDrug

    Participants will receive placebo matched to semaglutide subcutaneously.

Study groups in NCT06065540
Study groupRoleWhat they receive
CagriSema Dose 1ExperimentalParticipants will receive once-weekly subcutaneous (s.c) injections of cagrilintide dose 1 and semaglutide dose 1 for 68 weeks.
Receives: Drug: Cagrilintide; Drug: Semaglutide
CagriSema Dose 2ExperimentalParticipants will receive once-weekly s.c injections of cagrilintide dose 2 and semaglutide dose 2 for 68 weeks.
Receives: Drug: Cagrilintide; Drug: Semaglutide
Semaglutide Dose 1Active comparatorParticipants will receive once-weekly s.c injection of semaglutide dose 1 for 68 weeks.
Receives: Drug: Semaglutide
Semaglutide Dose 2Active comparatorParticipants will receive once-weekly s.c injection of semaglutide dose 2 for 68 weeks.
Receives: Drug: Semaglutide
Cagrilintide Dose 1Active comparatorParticipants will receive once-weekly s.c injection of cagrilintide dose 1 for 68 weeks.
Receives: Drug: Cagrilintide
Placebo Dose 1Placebo comparatorParticipants will receive once-weekly s.c injection of placebo matched to cagrilintide dose 1 and semaglutide dose 1 for 68 weeks.
Receives: Drug: Placebo cagrilintide; Drug: Placebo semaglutide
Placebo Dose 2Placebo comparatorParticipants will receive once-weekly s.c injection of placebo matched to cagrilintide dose 2 and semaglutide dose 2 for 68 weeks.
Receives: Drug: Placebo cagrilintide; Drug: Placebo semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CagriSema (dose 1) versus semaglutide (dose 1): Change in glycated haemoglobin (HbA1c)

    Measured in percentage-points.

    Measured: From baseline (week 0) to end of treatment (week 68)

Secondary outcomes (37)

  1. CagriSema versus cagrilintide: Change in HbA1c

    Measured in percentage-points.

    Measured: From baseline (week 0) to end of treatment (week 68)

  2. CagriSema versus cagrilintide: Relative change in body weight

    Measured in percentage.

    Measured: From baseline (week 0) to end of treatment (week 68)

  3. CagriSema (dose 1) versus semaglutide (dose 2): Change in HbA1c

    Measured in percentage-points.

    Measured: From baseline (week 0) to end of treatment (week 68)

  4. CagriSema versus semaglutide: Relative change in body weight

    Measured in percentage.

    Measured: From baseline (week 0) to end of treatment (week 68)

  5. Cagrilintide versus placebo: Change in HbA1c

    Measured in percentage-points.

    Measured: From baseline (week 0) to end of treatment (week 68)

  6. Cagrilintide versus placebo: Relative change in body weight

    Measured in percentage.

    Measured: From baseline (week 0) to end of treatment (week 68)

  7. CagriSema versus semaglutide: Achievement of greater than or equal to (>=) 10 percent (%) weight reduction

    Measured as count of participants.

    Measured: From baseline (week 0) to end of treatment (week 68)

  8. CagriSema versus semaglutide: Achievement of >= 15 % weight reduction

    Measured as count of participants.

    Measured: From baseline (week 0) to end of treatment (week 68)

  9. CagriSema versus semaglutide: Achievement of >= 20 % weight reduction

    Measured as count of participants.

    Measured: From baseline (week 0) to end of treatment (week 68)

  10. CagriSema (pooled doses) versus semaglutide (pooled doses): Continuous Glucose Monitoring (CGM) - Change in Time in Range (TIR) 3.9-10.0 millimoles per litre (mmol/L) (70-180 milligrams per decilitre [mg/dL])

    Measured in percentage-points.

    Measured: From baseline (week -3) to end of treatment (week 68)

  11. CagriSema versus semaglutide: CGM - Change in time in Tight Target Range (TITR) 3.9-7.8 (mmol/L) (70-140 mg/dL)

    Measured in percentage-points.

    Measured: From baseline (week -3) to end of treatment (week 68)

  12. CagriSema versus semaglutide: Change in Systolic Blood Pressure (SBP)

    Measured in millimeters of mercury (mmHg).

    Measured: From baseline (week 0) to end of treatment (week 68)

  13. CagriSema versus semaglutide: Ratio to baseline in triglycerides

    Measured as ratio of triglycerides.

    Measured: From baseline (week 0) to end of treatment (week 68)

  14. CagriSema versus semaglutide: Ratio to baseline in non-High Density Lipoprotein (HDL) cholesterols

    Measured as ratio of non-HDL cholesterol.

    Measured: From baseline (week 0) to end of treatment (week 68)

  15. CagriSema versus semaglutide: CGM - Change in Time In Range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL)

    Measured in percentage-points.

    Measured: From baseline (week -3) to end of treatment (week 68)

  16. CagriSema versus semaglutide: Ratio to baseline in high sensitivity C-Reactive Protein (hsCRP)

    Measured as ratio of hsCRP.

    Measured: From baseline (week 0) to end of treatment (week 68)

  17. CagriSema versus semaglutide: Change in Fasting Plasma Glucose (FPG)

    Measured in mmol/L.

    Measured: From baseline (week 0) to end of treatment (week 68)

  18. CagriSema versus semaglutide: Achievement of HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol])

    Measured as count of participants.

    Measured: At end of treatment (week 68)

  19. CagriSema versus semaglutide: Achievement of HbA1c target values of less than or equal to (≤)6.5% (≤48 mmol/mol)

    Measured as count of participants.

    Measured: At end of treatment (week 68)

  20. CagriSema versus semaglutide: CGM - Change in time above range, >10.0 mmol/L (>180 mg/dL)

    Measured in percentage-points.

    Measured: From baseline (week 0) to end of treatment (week 68)

  21. CagriSema versus semaglutide: CGM - Change in time above range, >13.9 mmol/L (>250 mg/dL)

    Measured in percentage-points.

    Measured: From baseline (week 0) to end of treatment (week 68)

  22. CagriSema versus semaglutide: CGM - Within-day glycaemic variability (% coefficient of variation [CV])

    Measured in percentage.

    Measured: At end of treatment (week 68)

  23. CagriSema versus semaglutide: Achievement of ≥ 5 % weight reduction

    Measured as count of participants.

    Measured: From baseline (week 0) to end of treatment (week 68)

  24. CagriSema versus semaglutide: Change in waist circumference

    Measured in centimetre.

    Measured: From baseline (week 0) to end of treatment (week 68)

  25. CagriSema versus semaglutide: Change in Diastolic Blood Pressure (DBP)

    Measured in mmHg.

    Measured: From baseline (week 0) to end of treatment (week 68)

  26. CagriSema versus semaglutide: Ratio to baseline in total cholesterol

    Measured as ratio of total cholesterol.

    Measured: From baseline (week 0) to end of treatment (week 68)

  27. CagriSema versus semaglutide: Ratio to baseline in HDL cholesterol

    Measured as ratio of HDL cholesterol.

    Measured: From baseline (week 0) to end of treatment (week 68)

  28. CagriSema versus semaglutide: Ratio to baseline in low-density lipoprotein (LDL) cholesterol

    Measured as ratio of LDL cholesterol.

    Measured: From baseline (week 0) to end of treatment (week 68)

  29. CagriSema versus semaglutide: Ratio to baseline in very low-density lipoprotein (VLDL) cholesterol

    Measured as ratio of VLDL.

    Measured: From baseline (week 0) to end of treatment (week 68)

  30. CagriSema versus semaglutide: Ratio to baseline in free fatty acids

    Measured as ratio of free fatty acids.

    Measured: From baseline (week 0) to end of treatment (week 68)

  31. CagriSema versus semaglutide: Change in Short Form (SF)-36v score- Physical component summary score

    SF-36v2 measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and an standard deviation of 10. Physical component summary score range from 6.1 to 79.7, with higher scores indicating better functional health and well-being.

    Measured: From baseline (week 0) to end of treatment (week 68)

  32. CagriSema versus semaglutide: Change in SF-36v2 score- Mental component summary score

    SF-36v2 measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and an standard deviation of 10. Mental component summary score range from -3.8 to 78.7, with higher scores indicating better functional health and well-being.

    Measured: From baseline (week 0) to end of treatment (week 68)

  33. CagriSema versus semaglutide: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score

    DTSQc measures treatment satisfaction and diabetes-specific quality of life (QoL). The measure consists of 8 items yielding 1 global score and 2 single item scores. Total treatment satisfaction scores range from 0-36, with higher scores indicating greater satisfaction; the perceived frequency of hyperglycemia/hypoglycemia items are scored separately, with lower scores indicating better perceived blood glucose control.

    Measured: From baseline (week 0) to end of treatment (week 68)

  34. CagriSema versus semaglutide: Change in Treatment Related Impact Measure for Diabetes (TRIM-D) score

    TRIM-D measures impact of diabetes treatment. The measure consists of 28 items yielding 5 domain scores and a total score. The scores were transformed to a 0-100 scale with higher scores indicating a better health state.

    Measured: From baseline (week 0) to end of treatment (week 68)

  35. CagriSema versus semaglutide, placebo and cagrilintide: Number of treatment emergent adverse events (TEAEs)

    Measured as count of events.

    Measured: From baseline (week 0) to end of study (week 75)

  36. CagriSema versus semaglutide: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter)

    Measured as count of episodes.

    Measured: From baseline (week 0) to end of study (week 75)

  37. CagriSema versus semaglutide: Number of severe hypoglycaemic episodes (level 3)

    Measured as count of episodes. Hypoglycaemia episodes (level 3) are the episodes associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold.

    Measured: From baseline (week 0) to end of study (week 75)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2023
  2. Study start27 Sep 2023
  3. Primary completion19 Nov 2025
  4. Study completion6 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,734 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06065540
Sponsor's protocol ID
NN9388-4896
Other IDs
U1111-1283-0427, 2022-502678-18
Acronym
REIMAGINE 2
Status last verified
Jul 2026
First submitted
26 Sep 2023
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • Buse JB, Bajaj HS, Dalskov SM, Donaldson L, Hansen Duus HH, Fabricius TW, Haluzik M, Lingvay I, Pedersen SD, Pratley RE, Jain AB; REIMAGINE 2 study group. Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study. Lancet Diabetes Endocrinol. 2026 Aug;14(8):662-677. doi: 10.1016/S2213-8587(26)00125-7. Epub 2026 Jun 7.

    PubMed 42251859

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cagrilintide and Semaglutide in people with Type 2 Diabetes Mellitus, run by Novo Nordisk A/S at 405 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 405 sites in United States, Canada, Poland, Turkey (Türkiye), Germany and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CagriSema (dose 1) versus semaglutide (dose 1): Change in glycated haemoglobin (HbA1c) (time frame: From baseline (week 0) to end of treatment (week 68)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06065540, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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