A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight

May 27, 2026 updated by: Novo Nordisk A/S

A Clinical Study to Compare Efficacy and Safety of Two Different Doses of CagriSema and Semaglutide in Participants With Obesity With or Without Type 2 Diabetes

This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Buenos Aires, Argentina, C1425AGC
        • Recruiting
        • Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
      • Buenos Aires, Argentina, C1119ACU
        • Recruiting
        • Kynet Recoleta
      • Buenos Aires, Argentina, C1015
        • Recruiting
        • OMI- Organización Médica de Investigación
      • Buenos Aires, Argentina, C1419
        • Recruiting
        • Hospital Sirio Libanes
      • CABA, Argentina, C1060ABA
        • Not yet recruiting
        • CEDIC Centro de Investigación Clínica
      • CABA, Argentina, C1061AAS.
        • Not yet recruiting
        • CIPREC Arenales
      • CABA, Argentina, C1120AAC
        • Not yet recruiting
        • Centro Médico Viamonte SRL
      • Ciudad de Buenos Aires, Argentina, C1204AAD
        • Not yet recruiting
        • Instituto Centenario
      • Santa Fe, Argentina, S3000FSO
        • Not yet recruiting
        • CEDIR - Centro de diagnóstico y rehabilitación Santa Fe
      • Santiago del Estero, Argentina, G4200
        • Recruiting
        • Sanatorio Norte
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1440CFD
        • Recruiting
        • CEMEDIC
      • Capital Federal, Buenos Aires, Argentina, C1056ABI
        • Recruiting
        • Centro de Investigaciones Metabólicas
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1424CIQ
        • Recruiting
        • CICEMO- Consultorio (Av Directorio)
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1427
        • Not yet recruiting
        • Centro Médico Arsema
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000DPX
        • Not yet recruiting
        • Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio
    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
        • Not yet recruiting
        • Sydney Clinical Trials
      • Gosford, New South Wales, Australia, 2250
        • Not yet recruiting
        • Gosford Renal Research
      • Liverpool, New South Wales, Australia, 2170
        • Not yet recruiting
        • Sydney Cardiometabolic Centre
      • Merewether, New South Wales, Australia, 2291
        • Not yet recruiting
        • Hunter Diabetes Centre
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Not yet recruiting
        • University of Sunshine Coast - Vitality Village
      • South Brisbane, Queensland, Australia, 4101
        • Not yet recruiting
        • University of Sunshine Coast - South Brisbane
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Not yet recruiting
        • Emeritus Research Melbourne
      • Graz, Austria, 8036
        • Not yet recruiting
        • Medical University of Graz
      • Mattersburg, Austria, 7210
        • Not yet recruiting
        • Ordination Winhofer-Stöckl
      • Saint Stefan, Austria, 8511
        • Not yet recruiting
        • Fließer-Görzer [Ordination]
      • Vienna, Austria, 1090
        • Not yet recruiting
        • Universitätsklinikum AKH Wien
      • Vienna, Austria, 1030
        • Not yet recruiting
        • Klinik Landstrasse
      • Vienna, Austria, 1120
        • Not yet recruiting
        • Ordination Dr. Günter Sokol
      • Vienna, Austria, 1130
        • Not yet recruiting
        • Klinik Hietzing 3. Med. Abt.
      • Vienna, Austria, 1180
        • Not yet recruiting
        • Itariu [Ordination]
      • Alken, Belgium, 3570
        • Not yet recruiting
        • Anima Research Center
      • Brussels, Belgium, 1200
        • Not yet recruiting
        • Cliniques universitaires Saint-Luc
      • Kluisbergen, Belgium, 9690
        • Not yet recruiting
        • KORMONT
      • La Louvière, Belgium, 7100
        • Not yet recruiting
        • CHU Tivoli
      • Mechelen, Belgium, 2800
        • Not yet recruiting
        • Meclinas
      • Roeselare, Belgium, 8800
        • Not yet recruiting
        • AZ Delta - Roeselare
      • Zwalm, Belgium, 9630
        • Not yet recruiting
        • KORMONT
      • Burgas, Bulgaria, 8000
        • Not yet recruiting
        • MC For Life EOOD
      • Kazanlak, Bulgaria, 6100
        • Not yet recruiting
        • MC Kazanlak EOOD
      • Kyustendil, Bulgaria, 2500
        • Not yet recruiting
        • Medical center Medi City 21 OOD
      • Pleven, Bulgaria, 5800
        • Not yet recruiting
        • OCSOMCE - Dr. Albena Dinkova EOOD
      • Plovdiv, Bulgaria, 4000
        • Not yet recruiting
        • AIPSMCEMDID - Dr. Georgi Levterov EOOD
      • Plovdiv, Bulgaria, 4002
        • Not yet recruiting
        • DCC Sveti Georgi EOOD
      • Sofia, Bulgaria, 1463
        • Not yet recruiting
        • Hipocrat 9 - Dr. Rumyana Boykova - Draganova - AISPEMD EOOD
      • Sofia, Bulgaria, 1618
        • Not yet recruiting
        • DCC XX - Sofia EOOD, Endocrinology
      • Sofia, Bulgaria, 1618
        • Not yet recruiting
        • MC Diamedical - 2013 OOD, Sofia
      • Sofia, Bulgaria, 1618
        • Not yet recruiting
        • Medical Centre Medical Arts Medico-dental centre
      • Sofia, Bulgaria, 1712
        • Not yet recruiting
        • DCC XXV Sofia EOOD, Endocrinology Consulting room
      • Stara Zagora, Bulgaria, 6003
        • Not yet recruiting
        • UMHAT Prof. Dr. Stoyan Kirkovich AD
      • Varna, Bulgaria, 9010
        • Not yet recruiting
        • AIPSMC Dr. Evelina Zlatanova EOOD
      • Veliko Tarnovo, Bulgaria, 5005
        • Not yet recruiting
        • MC Nevromedics EOOD, Internal Diseases
      • Québec, Canada, G1V 4T3
        • Not yet recruiting
        • Diex Recherche Quebec
      • Québec, Canada, G2J 0C4
        • Not yet recruiting
        • Alpha Recherche Clinique - Lebourgneuf
    • Alberta
      • Calgary, Alberta, Canada, T2V 4J2
        • Not yet recruiting
        • C-Health Partners
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5A8
        • Not yet recruiting
        • Kelowna Health and Memory Centre Ltd.
      • Kelowna, British Columbia, Canada, V1Y4N7
        • Not yet recruiting
        • Medical Arts Health Research Group_Kelowna
      • Surrey, British Columbia, Canada, V4A 0C1
        • Not yet recruiting
        • Hilltop Medical Clinic
      • Surrey, British Columbia, Canada, V3Z 2N6
        • Not yet recruiting
        • Ocean West Research Clinic
      • Victoria, British Columbia, Canada, V8V 4A1
        • Not yet recruiting
        • Dr. M.B. Jones Inc
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • Not yet recruiting
        • G.A. Research Associates Ltd.
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H1V7
        • Not yet recruiting
        • Nova Scotia Hlth Halifax
      • Sydney, Nova Scotia, Canada, B1M 0A1
        • Not yet recruiting
        • Care Access Cape Breton
    • Ontario
      • Brampton, Ontario, Canada, L6S 0C6
        • Not yet recruiting
        • Centricity Research Brampton Endocrinology
      • Guelph, Ontario, Canada, N1G 0B4
        • Not yet recruiting
        • Apex Trials
      • Hamilton, Ontario, Canada, L8L 5G4
        • Not yet recruiting
        • Hamilton Medical Research Group
      • Hamilton, Ontario, Canada, L8L 5G4
        • Not yet recruiting
        • Premier Clinical Trial Research Network (PCTRN)
      • Hamilton, Ontario, Canada, L8L 5G8
        • Not yet recruiting
        • Wharton Medical Clinic Clinical Trials (Hamilton)
      • London, Ontario, Canada, N5W 6A2
        • Not yet recruiting
        • Milestone Research
      • Sarnia, Ontario, Canada, N7T 4X3
        • Not yet recruiting
        • Bluewater Clin Res Group Inc
      • Toronto, Ontario, Canada, M6G 1M2
        • Not yet recruiting
        • Diabetes Heart Research Centre
    • Quebec
      • Montreal, Quebec, Canada, H4N 2W2
        • Not yet recruiting
        • Centre Medical Acadie
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Not yet recruiting
        • Centricity Res Pointe-Claire
      • Brno, Czechia, 656 91
        • Not yet recruiting
        • Fakultni nemocnice u sv. Anny v Brne
      • Dolní Břežany, Czechia, 252 41
        • Not yet recruiting
        • Centrum zdraví Dolní Břežany, a.s.
      • Liberec, Czechia, 460 01
        • Not yet recruiting
        • KARDIOLOGIE - LIBEREC s.r.o.
      • Náchod, Czechia, 54701
        • Not yet recruiting
        • Interní a diabetologická ordinace s.r.o.
      • Plzeň 3, Czechia, 301 00
        • Not yet recruiting
        • DIALINE s.r.o.
      • Prague, Czechia, 149 00
        • Not yet recruiting
        • MILAN KVAPIL s.r.o.
      • Prague, Czechia, 10400
        • Not yet recruiting
        • ENDOTRIAL s.r.o.
      • Prague, Czechia, 150 00
        • Not yet recruiting
        • EUC Klinika Praha a.s.
      • Prague, Czechia, 160 00
        • Not yet recruiting
        • Fledip s.r.o.
      • Bois-Guillaume, France, 76230
        • Not yet recruiting
        • CHU ROUEN_HOPITAL DE BOIS GUILLAUME_Service de Nutrition
      • Colmar, France, 68024
        • Not yet recruiting
        • CENTRE HOSPITALIER DE COLMAR_Endocrinologie/Diabetologie/Centre Nutritionnel
      • Le Coudray, France, 28630
        • Not yet recruiting
        • LES HOPITAUX DE CHARTRES_HOPITAL LOUIS PASTEUR_Service d'endocrinologie
      • Paris, France, 75015
        • Not yet recruiting
        • HOPITAL EUROPEEN GEORGES POMPIDOU_Service de nutrition et diabétologie
      • Paris, France, 75013
        • Not yet recruiting
        • APHP - LA PITIE SALPETRIERE _ Service de Nutrition
      • Pessac, France, 33600
        • Not yet recruiting
        • CHU DE BORDEAUX-HOPITAL HAUT LEVEQUE_Service d'Endocrinologie, Diabétologie et Maladies Métaboliques
      • Pierre-Bénite, France, 69310
        • Not yet recruiting
        • HCL-HOPITAL LYON SUD_Service d'Endocrinologie-Diabète-Nutrition
      • Saint-Herblain, France, 44800
        • Not yet recruiting
        • CHU NANTES - HOPITAL NORD LAENNEC_Service d'Endocrinologie-Diabétologie-Nutrition
      • Vénissieux, France, 69200
        • Not yet recruiting
        • CENTRE DE RECHERCHE CLINIQUE PORTES DU SUD_Service d'Endocrinologie-Diabétologie-Maladies Métaboliques
      • Alexandroupoli, Greece, 68100
        • Not yet recruiting
        • University General Hospital Of Alexandroupoli - First Department of Internal Medicine
      • Athens, Greece, 115 27
        • Not yet recruiting
        • Laiko General Hospital Of Athens - 1st department of Internal Medicine
      • Athens, Greece, 11525
        • Not yet recruiting
        • Athens Medical Center S.A. (Iatriko Psychicou) - Department of Internal Medicine & Metabolic Diseases
      • Athens, Greece, 11528
        • Not yet recruiting
        • General Hospital Of Athens Alexandra - Clinical Therapeutics
      • Athens, Greece, 10676
        • Not yet recruiting
        • Evangelismos S.A. - Endocrinology department
      • Lamia, Greece, 35100
        • Not yet recruiting
        • General Hospital Of Lamia - Internal Medicine Clinic
      • Marousi, Greece, 15125
        • Not yet recruiting
        • Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit
      • Palaió Fáliro, Greece, 17562
        • Not yet recruiting
        • Athens Medical Center S.A. (Iatriko P. Falirou) - Diabetes and Clinical Research Center
      • Peristeri, Greece, 121 31
        • Not yet recruiting
        • Athens Medical Center S.A. (Iatriko Peristeriou) - Diabetes, obesity and cardiometabolic diseases department
      • Thessaloniki, Greece, 54635
        • Not yet recruiting
        • NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes
      • Thessaloniki, Greece, 57001
        • Not yet recruiting
        • Thermi Clinic S.A. - Diabetes and Internal Medicine Department
      • Thessaloniki, Greece, 546 39
        • Not yet recruiting
        • Athens Medical Center S.A., European Interbalkan Medical Center - Department of Internal Medicine
      • Thessaloniki, Greece, 54635
        • Not yet recruiting
        • General Hospital Of Thessaloniki G Gennimatas - Internal Medicine Clinic
      • Baja, Hungary, 6500
        • Not yet recruiting
        • EURÉKA-CENTER Orvosi és Szolgáltató Betéti Társaság
      • Biatorbágy, Hungary, 2051
        • Not yet recruiting
        • Biatros Kft.
      • Budapest, Hungary, 1083
        • Not yet recruiting
        • Semmelweis Egyetem
      • Budapest, Hungary, H-1141
        • Not yet recruiting
        • Cardiogeneral Kft.
      • Békéscsaba, Hungary, 5600
        • Not yet recruiting
        • Békés Vármegyei Központi Kórház
      • Békéscsaba, Hungary, 5600
        • Not yet recruiting
        • Trial Pharma Kft.
      • Szolnok, Hungary, 5000
        • Not yet recruiting
        • Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Rendelőintézet
      • Székesfehérvár, Hungary, 8000
        • Not yet recruiting
        • Mentaház Kft.
    • Bekes County
      • Békéscsaba, Bekes County, Hungary, 5600
        • Not yet recruiting
        • Dr. Lakatos Ferenc Kardiológus ,Belgyógyász Magán szakrendelés
    • Bács-Kiskun county
      • Baja, Bács-Kiskun county, Hungary, 6500
        • Not yet recruiting
        • Lausmed Kft.
    • Csongrád-Csanád
      • Szeged, Csongrád-Csanád, Hungary, 6725
        • Not yet recruiting
        • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
    • Pest County
      • Budapest, Pest County, Hungary, 1036
        • Not yet recruiting
        • Óbudai Egészségügyi Centrum
      • Budapest, Pest County, Hungary, 1213
        • Not yet recruiting
        • Szatmári-Med Kft.
    • Szabolcs-Szatmár-Bereg
      • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Not yet recruiting
        • Medifarma-98 Kft.
      • Catanzaro, Italy, 88100
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria Renato Dulbecco
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Not yet recruiting
        • AOU IRCCS Policlinico di Sant'Orsola Malpighi - UOC Endocrinologia e Prevenzione e Cura del Diabete
    • Liguria
      • Genoa, Liguria, Italy, 16132
        • Not yet recruiting
        • IRCCS Ospedale Policlinico San Martino - U.O.D. Dietetica e Nutrizione Clinica
    • Lombardy
      • Brescia, Lombardy, Italy, 25123
        • Not yet recruiting
        • Spedali Civili Brescia - SSD Endocrinologia
      • Milan, Lombardy, Italy, 20132
        • Not yet recruiting
        • Ospedale San Raffaele S.r.l. - Unità di Cardio-metabolismo e Trials Clinici
    • Pg
      • Perugia, Pg, Italy, 06129
        • Not yet recruiting
        • Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
    • Sicily
      • Messina, Sicily, Italy, 98124
        • Not yet recruiting
        • D.A.I. Oncologico - U.O.C. di Chirurgia Generale ad indirizzo Oncologico
    • The Marches
      • Ancorna, The Marches, Italy, 60127
        • Not yet recruiting
        • INRCA Ancona - UOC Clinica Medica e Geriatrica
    • Tuscany
      • Pisa, Tuscany, Italy, 56126
        • Not yet recruiting
        • Azienda Ospedaliero Universitaria Pisana
      • Arnhem, Netherlands, 6815 AD
        • Not yet recruiting
        • Rijnstate Ziekenhuis
      • Eindhoven, Netherlands, 5623 EJ
        • Not yet recruiting
        • Catharina Zkh Eindhoven - Interne geneeskunde
      • Hoofddorp, Netherlands, 2134 TM
        • Not yet recruiting
        • Spaarne Gasthuis Hoofddorp - Interne
      • Hoogeveen, Netherlands, 7909 AA
        • Not yet recruiting
        • Bethesda Diabetes Research Center
      • Rotterdam, Netherlands, 3083 AN
        • Not yet recruiting
        • Ikazia Ziekenhuis
      • The Hague, Netherlands, 2565 KV
        • Not yet recruiting
        • Medisch Centrum Thomsonplein
    • Limburg
      • Born, Limburg, Netherlands, 6121 XK
        • Not yet recruiting
        • PreCare Trial & Recruitment
    • North Brabant
      • 's-Hertogenbosch, North Brabant, Netherlands, 5223 LA
        • Not yet recruiting
        • Progress Clinical Research Den Bosch
      • Bialystok, Poland, 15-276
        • Not yet recruiting
        • Uniwersytecki Szpital Kliniczny W Bialymstoku
      • Bialystok, Poland, 15-281
        • Not yet recruiting
        • Gabinet Leczenia Otylosci i Chorob Dietozaleznych
      • Bialystok, Poland, 15-481
        • Not yet recruiting
        • Kresmed Sp. z o. o.
      • Bialystok, Poland, 15-797
        • Not yet recruiting
        • Renew Clinic Sp. z o.o.
      • Bygdoszcz, Poland, 85-796
        • Not yet recruiting
        • Gierach-Med
      • Dębica, Poland, 39-200
        • Not yet recruiting
        • ETG Lublin Sp. z o.o.
      • Katowice, Poland, 40-648
        • Not yet recruiting
        • Pro Familia Altera Sp. z o.o.
      • Katowice, Poland, 40-748
        • Not yet recruiting
        • Vita Longa Sp. z o. o.
      • Krakow, Poland, 30-149
        • Not yet recruiting
        • Małopolskie Centrum Kliniczne
      • Poznan, Poland, 61-251
        • Not yet recruiting
        • Maciej Wiza Gaja Poradnie Lekarskie
      • Rzeszów, Poland, 35-055
        • Not yet recruiting
        • Centrum Medyczne Medyk Sp.zo.o. Sp.k.
      • Warsaw, Poland, 02-679
        • Not yet recruiting
        • Medon Clinical Research Sp. z o.o.
      • Warsaw, Poland, 00-124
        • Not yet recruiting
        • Gyncentrum Sp. z o. o.
      • Wroclaw, Poland, 52-416
        • Not yet recruiting
        • Centrum Medyczne Oporow
      • Wroclaw, Poland, 51-149
        • Not yet recruiting
        • Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego
      • Almada, Portugal, 2805-267
        • Not yet recruiting
        • ULS Almada-Seixal E.P.E. - HGO_Serviço de Endocrinologia
      • Caldas da Rainha, Portugal, 2500-176
        • Not yet recruiting
        • ULS Do Oeste E.P.E. - Unidade Caldas da Rainha_CAMI - Unidade de Diabetes
      • Figueira da Foz Municipality, Portugal, 3094-001
        • Not yet recruiting
        • ULS Do Baixo Mondego, E.P.E. - HDFF_Serviço Cardiologia
      • Lisbon, Portugal, 1500-650
        • Not yet recruiting
        • Hospital da Luz Lisboa, S.A._Serviço de Medicina Interna
      • Senhora Da Hora, Matosinhos, Portugal, 4464-513
        • Not yet recruiting
        • ULS De Matosinhos, E.P.E - HPH_Serviço de Endocrinologia
      • Torres Novas, Portugal, 2350-111
        • Not yet recruiting
        • Ucardio Centro Clinico Unidade Cardiovascular
      • Vila Nova de Gaia, Portugal, 4400-346
        • Not yet recruiting
        • Hospital da Luz Arrábida, S.A_Serviço de Endocrinologia
      • Vila do Conde, Portugal, 4480-565
        • Not yet recruiting
        • Hospital Trofa Saude Senhor do Bonfim S.A_Unidade de Ensaios Clínicos
      • Brasov, Romania, 500101
        • Not yet recruiting
        • Mariodiab Clinic SRL
      • Bucharest, Romania, 010507
        • Not yet recruiting
        • SC Nicodiab SRL
      • Buzău, Romania, 120133
        • Not yet recruiting
        • Mat Cord Biomedica S.R.L.
      • Oradea, Romania, 410469
        • Not yet recruiting
        • Spitalul Clinic Judetean De Urgenta Bihor
      • Piteşti, Romania, 110424
        • Not yet recruiting
        • Sc Sal Med Srl
      • Timișoara, Romania, 300288
        • Not yet recruiting
        • Cabinet Medical Dr Geru SRL
      • Timișoara, Romania, 300723
        • Not yet recruiting
        • Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
    • Bihor County
      • Oradea, Bihor County, Romania, 410159
        • Not yet recruiting
        • Grandmed SRL
    • Dolj
      • Craiova, Dolj, Romania, 200515
        • Not yet recruiting
        • S.C. Top Diabet Srl
    • Maramureş
      • Baia Mare, Maramureş, Romania, 430222
        • Not yet recruiting
        • CMI Dr Pop Lavinia
    • Mureș County
      • Târgu Mureş, Mureș County, Romania, 540142
        • Not yet recruiting
        • Sc Mediab Srl
      • Bojnice, Slovakia, 97201
        • Not yet recruiting
        • DIA - CLARUS s.r.o.
      • Bratislava, Slovakia, 851 01
        • Not yet recruiting
        • MEDISPEKTRUM s.r.o.
      • Bratislava, Slovakia, 84108
        • Not yet recruiting
        • KARDIO-SANUS, spol. s r.o.
      • Bytča, Slovakia, 014 01
        • Not yet recruiting
        • Diab - Int, s.r.o.
      • Košice, Slovakia, 04013
        • Not yet recruiting
        • ENDOMED, s.r.o.
      • Košice, Slovakia, 040 01
        • Not yet recruiting
        • HUMAN-CARE, s.r.o.
      • Martin, Slovakia, 036 01
        • Not yet recruiting
        • DIAMARTIN, s. r. o.
      • Spišská Nová Ves, Slovakia, 05201
        • Not yet recruiting
        • LUDIA, s. r. o.
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6001
        • Not yet recruiting
        • Phoenix Pharma
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Not yet recruiting
        • Iatros International
      • Bloemfontein, Free State, South Africa, 9301
        • Not yet recruiting
        • Medi-Clinic Bloemfontein
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2013
        • Not yet recruiting
        • Wits Bara Clinical Trial Site
      • Johannesburg, Gauteng, South Africa, 1827
        • Not yet recruiting
        • Hemant Makan
      • Johannesburg, Gauteng, South Africa, 1818
        • Not yet recruiting
        • Soweto Clinical Trial Centre
      • Johannesburg, Gauteng, South Africa, 2001
        • Not yet recruiting
        • Newtown Clinical Research
      • Johannesburg, Gauteng, South Africa, 2196
        • Not yet recruiting
        • Sandton Medical Research
      • Lenasia, Gauteng, South Africa, 1827
        • Not yet recruiting
        • Lenasia Clinical Trial Centre
      • Pretoria, Gauteng, South Africa, 0186
        • Not yet recruiting
        • Clinical Trial Systems (CTC)
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4450
        • Not yet recruiting
        • Dr Pillay's Rooms
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7500
        • Not yet recruiting
        • Tread Research (Pty)Ltd
      • Mossel Bay, Western Cape, South Africa, 6500
        • Not yet recruiting
        • Dr Hendrik Snyman's Practice
      • Paarl, Cape Town, Western Cape, South Africa, 7646
        • Not yet recruiting
        • Paarl Research Centre
      • Somerset West, Western Cape, South Africa, 7130
        • Not yet recruiting
        • Clinical Trials Network (Pty) Ltd
      • A Coruña, Spain, 15006
        • Not yet recruiting
        • Complejo Hospitalario Universitario A Coruña
      • Antequera, Spain, 29200
        • Not yet recruiting
        • Hospital Comarcal de Antequera
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08028
        • Not yet recruiting
        • CAPSBE_CAP Ernest LLuch
      • Centelles (Barcelona), Spain, 08540
        • Not yet recruiting
        • Eap Osona Sud Alt Congost S.L.P
      • Girona, Spain, 17002
        • Not yet recruiting
        • Clínica Bofill
      • Madrid, Spain, 28006
        • Not yet recruiting
        • Hospital Universitario de La Princesa
      • Madrid, Spain, 28006
        • Not yet recruiting
        • Hosp. Univ. Ruber Juan Bravo_Endocrinología
      • Madrid, Spain, 28016
        • Not yet recruiting
        • Hospital Universitario Sanitas Virgen del Mar
      • Madrid, Spain, 28942
        • Not yet recruiting
        • Hospital Universitario de Fuenlabrada
      • Manresa, Spain, 08243
        • Not yet recruiting
        • Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
      • Málaga, Spain, 29010
        • Not yet recruiting
        • H. Clinico Univ. Virgen de la Victoria
      • Valladolid, Spain, 47004
        • Not yet recruiting
        • Hosp. Recoletas Salud Campo Grande_Endoc y Nutric
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Not yet recruiting
        • Uni of Alabama at Birmingham
      • Pelham, Alabama, United States, 35124
        • Recruiting
        • Cahaba Research
    • Arizona
      • Gilbert, Arizona, United States, 85296
        • Not yet recruiting
        • Elligo Health Research Inc
      • Phoenix, Arizona, United States, 85006
        • Recruiting
        • Velocity Clinical Research-Phoenix
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Arkansas Clinical Research
      • Little Rock, Arkansas, United States, 72211
        • Not yet recruiting
        • Woodland Int. Research Group
    • California
      • Escondido, California, United States, 92025
        • Recruiting
        • Neighborhood Healthcare
      • Escondido, California, United States, 92025
        • Recruiting
        • Headlands Research California, LLC
      • La Mesa, California, United States, 91942
        • Recruiting
        • Diabetes & Endocrine Specialists - La Mesa
      • Lincoln, California, United States, 95648
        • Recruiting
        • Clinical Trials Research_Sacramento
      • Loma Linda, California, United States, 92354
        • Not yet recruiting
        • Loma Linda University Faculty Medical Clinics
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • Pacific Clinical Studies
      • Northridge, California, United States, 91325
        • Recruiting
        • Valley Clinical Trials
      • Palm Springs, California, United States, 92262
        • Recruiting
        • Desert Oasis Healthcare
      • San Diego, California, United States, 92111
        • Recruiting
        • Linda Vista Health Care Ctr
      • Van Nuys, California, United States, 91405
        • Recruiting
        • Velocity Clin Res - Van Nuys
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Flourish Research - CA
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • University of Colorado Hospital
    • Florida
      • Clearwater, Florida, United States, 33761
        • Recruiting
        • TBMR & Alcanza
      • Fleming Island, Florida, United States, 32003
        • Recruiting
        • Northeast Research Institute
      • Jacksonville, Florida, United States, 32204
        • Recruiting
        • Northeast Research Institute
      • Jacksonville, Florida, United States, 32205
        • Not yet recruiting
        • Westside Center for Clinical Research
      • Miami, Florida, United States, 33165
        • Recruiting
        • New Horizon Research Center
      • Miami, Florida, United States, 33155
        • Recruiting
        • Bioclinical Research Alliance
      • Miramar, Florida, United States, 33027
        • Recruiting
        • South Broward Research LLC
      • Ocoee, Florida, United States, 34761
        • Recruiting
        • West Orange Endocrinology
      • Oviedo, Florida, United States, 32765
        • Recruiting
        • Oviedo Medical Research, LLC
      • Pembroke Pines, Florida, United States, 33024
        • Not yet recruiting
        • Clinical Trial Services Corp
    • Georgia
      • Conyers, Georgia, United States, 30094
        • Recruiting
        • Hope Clin Res & Wellness
      • Gainesville, Georgia, United States, 30501
        • Recruiting
        • Center for Adv Res & Education
      • Roswell, Georgia, United States, 30076
        • Recruiting
        • Endocrine Research Solutions, Inc
      • Woodstock, Georgia, United States, 30189-4255
        • Recruiting
        • North Georgia Clinical Research
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Recruiting
        • Solaris Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Not yet recruiting
        • Cedar-Crosse Research Center
      • Gillespie, Illinois, United States, 62033
        • Recruiting
        • Macoupin Fam Practice Ctr, LLP
      • Gurnee, Illinois, United States, 60031
        • Recruiting
        • Clinical Investigation Spec Gurnee
      • Skokie, Illinois, United States, 60077
        • Recruiting
        • Evanston Premier Hlthcr Res
      • Skokie, Illinois, United States, 60077
        • Not yet recruiting
        • Endeavor Health
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Not yet recruiting
        • Iowa Diabetes Research
    • Kansas
      • Newton, Kansas, United States, 67114
        • Recruiting
        • Alliance for Multispecialty Research
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • Cotton O'Neil Diab & Endo Ctr
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • The Research Group of Lexington LLC
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Not yet recruiting
        • Endo and Metabolic Consultants
    • Michigan
      • Buckley, Michigan, United States, 49620
        • Recruiting
        • Northern Pines Hlth Ctr, PC
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Not yet recruiting
        • International Diabetes Center
      • Richfield, Minnesota, United States, 55423
        • Recruiting
        • AES Minneapolis DRS
    • Mississippi
      • Belzoni, Mississippi, United States, 39038
        • Not yet recruiting
        • Belzoni Clinical Research
    • Missouri
      • Chesterfield, Missouri, United States, 63005
        • Recruiting
        • Clinical Research Professionals
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • Amicis Centers of Clinical Research
    • New York
      • West Seneca, New York, United States, 14224
        • Recruiting
        • Southgate Medical Group, LLP
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Recruiting
        • PharmQuest Life Sciences LLC
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • Physician's East Endocrinology
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Carteret Medical Group
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Centricity Rsrch MHCity Multi
      • Statesville, North Carolina, United States, 28625
        • Recruiting
        • Piedmont Healthcare/Research
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • Accellacare Wilmington
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Recruiting
        • Lillestol Research LLC
      • Fargo, North Dakota, United States, 58104
        • Not yet recruiting
        • Plains Clinical Research Center, LLC
    • Ohio
      • Maumee, Ohio, United States, 43537
        • Recruiting
        • Advanced Medical Research
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Recruiting
        • Alliance for Multispecialty Research
      • Norman, Oklahoma, United States, 73072
        • Recruiting
        • Lynn Institute of Norman
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Not yet recruiting
        • Heritage Valley Medical Group
      • Hatboro, Pennsylvania, United States, 19040
        • Recruiting
        • Hatboro Med Associates
      • Philadelphia, Pennsylvania, United States, 19114
        • Not yet recruiting
        • Northeast Endocrine Metabolic Associates
    • Rhode Island
      • Cumberland, Rhode Island, United States, 02864
        • Recruiting
        • Clinical Res Collaborative
    • South Carolina
      • Gaffney, South Carolina, United States, 29340
        • Not yet recruiting
        • Velocity Clinical Research-Gaffney
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Spartanburg Medical Research
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Recruiting
        • Jackson Clinic
      • Kingsport, Tennessee, United States, 37660
        • Recruiting
        • Holston Medical Group
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • CNS Healthcare
      • Morristown, Tennessee, United States, 37813
        • Recruiting
        • HealthStar Physicians, PC
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Clinical Research Associates
    • Texas
      • Amarillo, Texas, United States, 79124
        • Recruiting
        • Amarillo Med Spec LLP
      • Austin, Texas, United States, 78759
        • Recruiting
        • Velocity Clinical Research Austin
      • Austin, Texas, United States, 78731
        • Recruiting
        • Texas Diab & Endo, P.A.
      • Dallas, Texas, United States, 75231
        • Recruiting
        • North Texas Endocrine Center
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Velocity Clin Res, Dallas
      • Euless, Texas, United States, 76040
        • Not yet recruiting
        • Cedar Health Research
      • Houston, Texas, United States, 77079
        • Recruiting
        • The Endocrine Center
      • Houston, Texas, United States, 77040
        • Recruiting
        • JCCT- Juno NW Houston
      • Katy, Texas, United States, 77450
        • Not yet recruiting
        • Medical Colleagues-Texas LLP
      • Kerrville, Texas, United States, 78028
        • Recruiting
        • Sante Clinical Research
      • Lampasas, Texas, United States, 76550
        • Recruiting
        • Radiance Clinical Research
      • Laredo, Texas, United States, 78041
        • Recruiting
        • Aeres Clinical Research
      • Longview, Texas, United States, 75605
        • Recruiting
        • DCOL Ctr for Clin Res
      • McAllen, Texas, United States, 78503
        • Recruiting
        • RGV Endocrine Center
      • San Antonio, Texas, United States, 78233
        • Recruiting
        • Northeast Clinical Research of San Antonio
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • AES San Antonio
      • San Antonio, Texas, United States, 78209
        • Recruiting
        • Quality Research Inc
      • Shavano Park, Texas, United States, 78231
        • Recruiting
        • Consano Clinical Research, LLC
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • Mt Olympus Medical Research, LLC
    • Utah
      • Salt Lake City, Utah, United States, 84109
        • Recruiting
        • J.Lewis Research Inc
      • Salt Lake City, Utah, United States, 84121
        • Recruiting
        • J.Lewis Research Inc
      • Sandy City, Utah, United States, 84093
        • Not yet recruiting
        • Diabetes & Endo Tx Specialists
      • South Jordan, Utah, United States, 84095
        • Recruiting
        • J.Lewis Research Inc
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Recruiting
        • Tidewater Physicians Multispecialty Group
      • Newport News, Virginia, United States, 23606
        • Recruiting
        • Health Res of Hampton Roads
      • Richmond, Virginia, United States, 23294
        • Recruiting
        • National Clin Res Inc.
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54303
        • Not yet recruiting
        • Prevea Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria :

  • Male or female (sex assigned at birth, inclusive of all gender identities).
  • Age 18 years or above at the time of signing the informed consent.
  • BMI≥ 35.0 kg/m^2.
  • Participants without T2D: No history of T2D and HbA1c < 6.5% (48 millimoles per mole (mmol/mol)) Participants with T2D: A history of T2D and HbA1c < 10% (< 86 mmol/mol). If a participant without a history of diabetes during the screening period receives an HbA1c result of 6.5% (48 mmol/mol) or higher, the investigator or the participant's healthcare provider must confirm the diagnosis of type 2 diabetes before the participant is randomised.

Exclusion Criteria:

  • A self-reported change in body weight > 5% within 90 days before screening, irrespective of medical records.
  • Use of any glucagon-like-peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin analogues, including medication with amylin activity, within 6 months before screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cagrisema - dose level 1
Participants will receive CagriSema at dose level 1 once weekly subcutaneously during the treatment period for 72 weeks.
Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
Active Comparator: Cagrisema - dose level 2
Participants will receive CagriSema at dose level 2 once weekly subcutaneously during the treatment period for 72 weeks.
Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
Active Comparator: Semaglutide
Participants will receive Semaglutide once weekly subcutaneously during the treatment period for 72 weeks.
Semaglutide will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative change in body weight
Time Frame: From randomisation (week 0) to end of treatment (week 72)
Measured as percentage (%).
From randomisation (week 0) to end of treatment (week 72)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative change in body weight
Time Frame: From randomisation (week 0) to end of treatment (week 72)
Measured as %.
From randomisation (week 0) to end of treatment (week 72)
Change in Body Mass Index (BMI)
Time Frame: From randomisation (week 0) to end of treatment (week 72)
Measured as kilograms per square metre (kg/m^2).
From randomisation (week 0) to end of treatment (week 72)
Number of participants who achieve greater than or equal to (≥) 30% weight reduction
Time Frame: From randomisation (week 0) to end of treatment (week 72)
Measured as count of participants.
From randomisation (week 0) to end of treatment (week 72)
Number of participants who achieve ≥25% weight reduction
Time Frame: From randomisation (week 0) to end of treatment (week 72)
Measured as count of participants.
From randomisation (week 0) to end of treatment (week 72)
Number of participants who achieve greater ≥ 20% weight reduction
Time Frame: From randomisation (week 0) to end of treatment (week 72)
Measured as count of participants.
From randomisation (week 0) to end of treatment (week 72)
Change in waist circumference
Time Frame: From randomisation (week 0) to end of treatment (week 72)
Measured in centimetre (cm).
From randomisation (week 0) to end of treatment (week 72)
Mean change in body weight
Time Frame: From randomisation (week 0) to end of treatment (week 72)
Measured in kilograms (kg).
From randomisation (week 0) to end of treatment (week 72)
Number of participants who achieve a BMI less than (<) 30 kg/m^2
Time Frame: From randomisation (week 0) to end of treatment (week 72)
Measured as count of participants.
From randomisation (week 0) to end of treatment (week 72)
Number of participants who achieve BMI <27 kg/m^2
Time Frame: end of treatment (week 72)
Measured as count of participants.
end of treatment (week 72)
Number of participants who achieve normal BMI, defined as 18.5 lesser than or equal to (≤) BMI < 25 kg/m^2
Time Frame: At end of treatment (week 72)
Measured as count of participants.
At end of treatment (week 72)
Number of participants who achieve a waist-to-height ratio < 0.53
Time Frame: At end of treatment (week 72)
Measured as count of participants.
At end of treatment (week 72)
Ratio to baseline : Total cholesterol
Time Frame: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
From baseline (week 0) to end of treatment (week 72)
Ratio to baseline : High density lipoprotein (HDL) cholesterol
Time Frame: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
From baseline (week 0) to end of treatment (week 72)
Ratio to baseline : Low density lipoprotein (LDL) cholesterol
Time Frame: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
From baseline (week 0) to end of treatment (week 72)
Ratio to baseline : Very low density lipoprotein ( VLDL) cholesterol
Time Frame: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
From baseline (week 0) to end of treatment (week 72)
Ratio to baseline : Triglycerides
Time Frame: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
From baseline (week 0) to end of treatment (week 72)
Ratio to baseline: Free fatty acids
Time Frame: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
From baseline (week 0) to end of treatment (week 72)
Ratio to baseline : Non-HDL cholesterol
Time Frame: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
From baseline (week 0) to end of treatment (week 72)
Change in Short-Form-36 Health Survey Version 2.0 (SF-36v2) physical Function
Time Frame: From randomisation (week 0) to end of treatment (week 72)
Measured as score on a scale. The SF-36v2 acute measures health-related quality of life (HRQOL). The 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 United States general population has a mean of 50 and a standard deviation of 10. Physical functioning score ranges from 19.0-57.6, with higher scores indicating better functional health and well-being.
From randomisation (week 0) to end of treatment (week 72)
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) physical function
Time Frame: From randomisation (week 0) to end of treatment (week 72)
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Physical function score ranges from 0 to 100, with higher scores indicating better levels of functioning.
From randomisation (week 0) to end of treatment (week 72)
Change in glycated haemoglobin (HbA1c)
Time Frame: From randomisation (week 0) to end of treatment (week 72)
Measured in %-points.
From randomisation (week 0) to end of treatment (week 72)
Number of participants who achieve HbA1c <6.5%
Time Frame: At end of treatment (week 72)
Measured as count of participants.
At end of treatment (week 72)
Number of participants who achieve normal HbA1c <5.7%
Time Frame: At end of treatment (week 72)
Measured as count of participants.
At end of treatment (week 72)
Number of treatment-emergent adverse events (TEAEs)
Time Frame: From randomisation (week 0) to end of study (week 80)
Measured in number of events.
From randomisation (week 0) to end of study (week 80)
Number of treatment-emergent serious adverse events (TESAEs)
Time Frame: From randomisation (week 0) to end of study (week 80)
Measured in number of events.
From randomisation (week 0) to end of study (week 80)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2026

Primary Completion (Estimated)

February 23, 2028

Study Completion (Estimated)

April 19, 2028

Study Registration Dates

First Submitted

April 27, 2026

First Submitted That Met QC Criteria

April 27, 2026

First Posted (Actual)

May 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • NN9838-7910
  • U1111-1323-0372 (Other Identifier: World Health Organization)
  • 2025-522488-14 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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