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

Type 2 Diabetes Mellitus Clinical Trial

— REIMAGINE 2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06065540
• Other study ID #: NN9388-4896
• Secondary ID: U1111-1283-04272
• Status: Recruiting
• Phase: Phase 3
• Start date: September 27, 2023
• Est. completion date: January 14, 2026

Study information

• Verified date: June 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2700
• Est. completion date: January 14, 2026
• Est. primary completion date: November 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female.

• 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.

Exclusion Criteria:

• 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 a fundus examination performed within 90 days before screening or in the period between screening and randomisation.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Cagrilintide
Participants will receive once-weekly s.c injection of cagrilintide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of cagrilintide is reached.
• Semaglutide
Participants will receive once-weekly s.c injection of semaglutide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of semaglutide is reached.
• Placebo cagrilintide
Participants will receive placebo matched to cagrilintide subcutaneously.
• Placebo semaglutide
Participants will receive placebo matched to semaglutide subcutaneously.

Locations

Country	Name	City	State
Argentina	Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli	Buenos Aires
Argentina	STAT Research	Buenos Aires
Argentina	Centro de Investigación y Prevención Cardiovascular	Caba
Argentina	Mautalen Salud e investigación	Caba	Buenos Aires
Argentina	Sanatorio Güemes	Caba	City Of Buenos Aires
Argentina	Instituto de Investigaciones Clínicas Rosario	Rosario	Santa Fe
Australia	Clinical Research Facility, Charles Perkins Centre	Camperdown	New South Wales
Australia	Holdsworth House Clinical Research	Darlinghurst	New South Wales
Australia	St Vincent's Hospital - Melbourne	Fitzroy	Victoria
Australia	Macquarie University	Macquarie Park	New South Wales
Australia	Logan Hospital	Meadowbrook	Queensland
Australia	Baker IDI Heart and Diabetes Institute	Melbourne	Victoria
Australia	Hunter Diabetes Centre	Merewether	New South Wales
Australia	Southern Adelaide Diabetes & Endocrine Services	Oaklands Park	South Australia
Brazil	Cline Research Center	Curitiba	Parana
Brazil	CPCLIN - Centro de Pesquisas Clínicas	São Paulo	Sao Paulo
Brazil	CPQuali Pesquisa Clínica Ltda	São Paulo	Sao Paulo
Bulgaria	"IPSMC - d-r Nikolay Kostadinov" EOOD	Burgas
Bulgaria	"Dr Tatyana Metalova - ambulatory for individual practice for specialised medical care for endocrinology" EOOD	Gotse Delchev
Bulgaria	Ambulatory for specialised outpatient medical care for Endocrinology and Internal diseases - Individual Practice - Dr Abdul-Aziz	Kardzhali
Bulgaria	Medical Center Zdrave Lom	Lom
Bulgaria	Medical centre Razgrad OOD	Razgrad
Bulgaria	"Medical Center Maraya Med" EOOD	Sofia
Bulgaria	Diagnostic Consulting Center Ascendent	Sofia
Bulgaria	Medical centre Clinic Nova	Varna
Bulgaria	UMHAT Sveta Marina EAD	Varna
Canada	Centricity Res. Barrie Endo	Barrie	Ontario
Canada	Centricity Research Brampton	Brampton	Ontario
Canada	Centricity Research Calgary	Calgary	Alberta
Canada	Centricity Research Vaughn	Concord	Ontario
Canada	Medical Trust Clinics, Inc.	Courtice	Ontario
Canada	Centricity Research Etobicoke	Etobicoke	Ontario
Canada	Milestone Research	London	Ontario
Canada	Western Univ. Cnt for Studies in Fam Med	London	Ontario
Canada	My Endo Diabetes & Endo Cent	Markham	Ontario
Canada	G.A. Research Associates Ltd.	Moncton	New Brunswick
Canada	Centre Medical Acadie	Montreal	Quebec
Canada	Centricity Research Ottawa LMC	Nepean	Ontario
Canada	Centricity Research Oshawa	Oshawa	Ontario
Canada	Centricity Res Pointe-Claire	Pointe-Claire	Quebec
Canada	Centre de Recherche Saint-Louis	Quebec
Canada	Clin des Mal Lipid de Quebec	Quebec
Canada	Diex Recherche Quebec Inc.	Quebec
Canada	ALPHA Recherche Clinique	Quebec City	Quebec
Canada	LMC Clin Rsrch Inc. (Montreal)	Saint-Laurent	Quebec
Canada	Q & T Research Sherbrooke Inc.	Sherbrooke	Quebec
Canada	Synergy Wellness Clinic	Sherwood Park	Alberta
Canada	Guilford Med Clinic	Surrey	British Columbia
Canada	Hilltop Medical Clinic	Surrey	British Columbia
Canada	Ocean West Research Clinic	Surrey	British Columbia
Canada	TLC Diabetes and Endocrinology	Surrey	British Columbia
Canada	Ctr de Med Metab de Lanaudiere	Terrebonne	Quebec
Canada	Centricity Research Toronto	Toronto	Ontario
Canada	Diabetes Heart Research Centre	Toronto	Ontario
Canada	Spectrum Health Clinic	Vancouver	British Columbia
Canada	Diex Recherche Victoriaville	Victoriaville	Quebec
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Chinese People's Liberation Army General Hospital	Beijing	Beijing
China	Chongqing University Three Gorges Hospital	Chongqing	Chongqing
China	Jinan Central Hospital	Ji'Nan	Shandong
China	Huaihe Hospital of Henan University	Kaifeng	Henan
China	The Second Affiliated Hospital of Nanjing Medical University_Nanjing	Nanjing	Jiangsu
China	Suzhou Municipal Hospital	Suzhou	Jiangsu
China	The Affiliated Hospital of Jiangsu University_Zhenjiang	Zhenjiang	Jiangsu
Colombia	Cimedical	Barranquilla
Colombia	Clinica Imbanco SAS	Cali
Colombia	FOSCAL	Floridablanca	Santander
Colombia	IMAT - Oncomedica	Monteria
Croatia	Thalassotherapia Opatija	Opatija
Croatia	Poliklinika SLAVONIJA OSIJEK	Osijek	Osjecko - Baranjska Županija
Croatia	KBC Rijeka, Endokrinologija	Rijeka	Primorsko - Goranska Županija
Croatia	Opca bolnica Dr. Josip Bencevic	Slavonski Brod
Croatia	Opca bolnica Varazdin	Varazdin
Croatia	Poliklinika Solmed	Zagreb	Grad Zagreb
Czechia	University Hospital U sv. Anny	Brno
Czechia	Edumed Broumov	Broumov
Czechia	Diahaza s.r.o.	Holešov
Czechia	DIALINE s.r.o.	Plzen 3
Czechia	Diabet2 s.r.o.	Praha 1
Czechia	IKEM Centrum Diabetologie	Praha 4	Czech Republic
Czechia	MUDr. Michala Pelikanova	Praha 4
Denmark	Aarhus Universitetshospital, Steno Diabetes Center Aarhus	Aarhus N
Denmark	Steno Diabetes Center Copenhagen	Herlev
Denmark	Hillerød Endokrinologisk amb. H0652	Hillerød
Denmark	Hvidovre Hospital Endokrinologisk amb. 541	Hvidovre
Denmark	Bispebjerg Hospital, IC-Forskning	København
Denmark	Steno Diabetes Center Odense	Odense C
Denmark	Steno Diabetes Center Odense	Odense C
Finland	Terveystalo Jyväskylä	Jyväskylä
Finland	Seinäjoen keskussairaala	Seinäjoki
Finland	Pihlajalinna Koskiklinikka	Tampere
Finland	Terveystalo Tampere Rautatienkatu	Tampere
Finland	Turku University Hospital	Turku
Germany	Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR	Berlin
Germany	Diabetologische Schwerpunktpraxis Daaden	Daaden
Germany	Diabeteszentrum-Do Dres. K U. Ch. Busch GbR	Dortmund
Germany	Medizinische Klinik III Studienzentrum für Stoffwechselerkrankungen der TU Dresden	Dresden
Germany	Zentrum fuer klinische Studien Suedbrandenburg GmbH	Elsterwerda
Germany	InnoDiab Forschung GmbH	Essen
Germany	MVZ Diabeteszentrum Dr. Tews GmbH	Gelnhausen
Germany	Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR	Hamburg
Germany	Diabetes-Zentrum-Wilhelmsburg GbR	Hamburg
Germany	Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz	Lingen
Germany	Universitätsklinikum Schleswig-Holstein	Lübeck
Germany	Die Praxis am Ludwigsplatz	Ludwigshafen
Germany	Medicover Neuroendokrinologie MVZ	München
Germany	RED-Institut für medizinische Forschung und Fortbildung GmbH	Oldenburg in Holstein
Germany	Praxis für Innere Medizin	Zwenkau
Greece	"Laiko" General Hospital of Athens	Athens
Greece	General hospital of Athens 'G.Gennimatas'	Athens
Greece	Iatriko Athinon (Athens Medical Canter)	Athens
Greece	Iatriko Psychicou Private Clinic	Athens
Greece	University Hospital of Athens ATTIKON	Haidari-Athens	Attica
Greece	Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease	Larissa
Greece	General Hospital Of Thessaloniki Papageorgiou	Nea Efkarpia	Thessaloniki
Greece	"AHEPA" University Hospital of Thessaloniki	Thessaloniki
Greece	"AHEPA" University Hospital of Thessaloniki	Thessaloniki
Greece	"Ippokrateio" G.H. of Thessaloniki	Thessaloniki
Greece	EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes	Thessaloniki
Hungary	Bajcsy-Zsilinszky Kórház	Budapest
Hungary	MH Egészségügyi Központ	Budapest
Hungary	Óbudai Egészségügyi Centrum	Budapest
Hungary	Debreceni Egyetem Belgyógyászati Klinika	Debrecen	Hajdu-Bihar
Hungary	Kaposi Mór Oktató Kórház	Kaposvár
Hungary	Kanizsai Dorottya Kórház	Nagykanizsa
Hungary	Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ	Szeged	Csongrád-Csanád
Hungary	Markusovszky Egyetemi Oktatókórház	Szombathely
Hungary	Zala Megyei Szent Rafael Kórház	Zalaegerszeg
India	Swasthya Diabetes Care	Ahmedabad
India	Lifecare Hospital and Research Centre	Bengaluru	Karnataka
India	Post Graduate Institute of Medical Education & Research	Chandigarh
India	Madras Diabetes Research Foundation	Chennai	Tamil Nadu
India	KG Hospital	Coimbatore	Tamil Nadu
India	Gauhati Medical College and Hospital	Guwahati	Assam
India	Gleneagles Hospitals	Hyderabad	Telangana
India	Kumudini Devi Diabetes Research Center, Ramdevrao Hospital	Hyderabad	Telangana
India	SMS Medical College & Hospital	Jaipur	Rajasthan
India	Apollo Multispeciality Hospital, Kolkata	Kolkata	West Bengal
India	BYL Nair Hospital and T N Medical College Department of endo	Mumbai	Maharashtra
India	K R Hospital	Mysuru	Karnataka
India	Lady Hardinge Medical College	New Delhi
India	Ashirwad Hospital and Research Centre	Thane	Maharashtra
India	Yalamanchi Hospitals and Research centres pvt ltd	Vijaywada	Andhra Pradesh
Israel	Linn clinic - Clalit Health Services	Haifa
Israel	Clalit sick fund Herzlia	Herzlia
Israel	Diabetes Clinic Wolfson MC	Holon
Israel	Diabetes Unit Hadassah Ein Karem MC	Jerusalem
Israel	Kaplan MC	Rehovot
Israel	Endrocrinolgy Clinic - Sheba Medical Center	Tel Hashomer
Italy	Azienda Sanitaria Usl Toscana Sud Est - Ospedale San Donato	Arezzo
Italy	Azienda Ospedaliera Papa Giovanni XXIII	Bergamo
Italy	Azienda Ospedaliero-Universitaria Renato Dulbecco	Catanzaro
Italy	Università degli studi G. D'Annunzio Chieti Pescara - CAST	Chieti Scalo
Italy	AOU Careggi Firenze	Firenze	Fi
Italy	Azienda Ospedaliera Luigi Sacco	Milano
Italy	Istituto Scientifico San Raffaele	Milano	MI
Italy	Azienda Ospedaliera Universitaria Federico II di Napoli	Napoli
Italy	AOUP Giaccone Palermo	Palermo
Italy	Dip. di Medicina Interna Policlinico Universitario Palermo	Palermo
Italy	Azienda Ospealiero Universitaria Policlinico Umberto I	Roma
Italy	Policlinico A. Gemelli	Rome
Italy	AOU Integrata di Verona - Ospedale Civile Maggiore	Verona
Japan	Akaicho Clinic	Chiba-shi, Chiba
Japan	Naka Kinen Clinic	Ibaraki
Japan	Seino Internal Medicine Clinic	Koriyama-shi	Fukushima, Japan
Japan	Minami Akatsuka Clinic	Mito-shi, Ibaraki
Japan	Abe Diabetes Clinic_Internal Medicine	Oita-shi	Oita, Japan
Japan	Medical Research Institute KITANO HOSPITAL, Diabetes & Endocrinology	Osaka-shi, Osaka
Japan	Fukuwa Clinic	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Tokyo
Korea, Republic of	The catholic university of Korea, Bucheon St.Mary's Hospital	Bucheon-si	Gyeonggi-do
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Chosun University Hospital	Gwangju
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Kyunghee University Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Mexico	Centro de Estudios de Investigación Metabólicos y Cardio	Ciudad Madero	Tamaulipas
Mexico	Centro de Investigacion Clinica Endocrinologica de Jalisco	Guadalajara	Jalisco
Mexico	InstitutoJalisciense de Investigación en Diabetes y Obesidad	Guadalajara	Jalisco
Mexico	Centro de investigación en Artritis y Osteoporosis S.C.	Mexicali	Baja California
Poland	NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Malgorzata Arciszewska	Bialystok	Podlaskie
Poland	Osteo Medic s.c. Artur Racewicz Jerzy Supronik	Bialystok	Podlaskie
Poland	Centrum Medyczne Pratia Bydgoszcz	Bydgoszcz
Poland	Malopolskie Centrum Sercowo-Naczyniowe	Chrzanow	Malopolskie
Poland	PAKS III Oddzial Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii	Dabrowa-Górnicza	Slaskie
Poland	Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski	Gorzow Wielkopolski	Lubuskie
Poland	Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika	Lodz	Lodzkie
Poland	Ko-Med Nova Sp.zo.o. Lublin II	Lublin
Poland	KO-MED Centra Kliniczne Sp. z o.o.	Pulawy
Poland	Centrum Medyczne Medyk Sp. z o.o.	Rzeszow	Podkarpackie
Poland	Velocity Nova Sp. z o.o.	Staszow
Poland	PAKS III Oddzial Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii	Tychy	Slaskie
Poland	Instytut Diabetologii Sp. z o.o.	Warszawa	Mazovian Voivodeship
Poland	NBR Polska Tomasz Klodawski	Warszawa
Poland	Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji	Warszawa
Poland	Zgierskie Centrum Kardiologii Med-Pro Polsko-Amerykanskich Klinik Serca	Zgierz
Poland	Prywatna Praktyka Lekarska Anna Chudoba	Zyrardów	Masovian
Romania	CMI Dr. Pletea Noemi SRL	Bacau
Romania	Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed	Brasov
Romania	Mariodiab Clinic SRL	Brasov
Romania	Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila	Bucharest	Bucurestii
Romania	Diabet Med SRL	Bucuresti
Romania	Spitalul Clinic Judetean Urgenta Cluj-Napoca	Cluj Napoca	Cluj
Romania	Urodiamed SRL	Craiova
Romania	S.C Milena Sante SRL	Galati
Romania	Gama Diamed Srl	Mangalia
Romania	Bella Praxis S.R.L.	Pascani
Romania	Cabinet Medical Individual Dr. Ramona Dragut SRL	Pitesti	Arges
Romania	CMI Dr. Busegeanu Mihaela Magdalena	Ploiesti	Prahova
Romania	Diabmed Dr Popescu Alexandrina SRL	Ploiesti	Prahova
Romania	Poli Cardinal Med Srl	Reghin
Romania	Cabinet Medical de Diabet, Nutritie si Boli Metabolice-Dr. Zaharie Daniela Gabriela	Zalau	Salaj
Serbia	CHC Zvezdara, Clinical department for endocrinology	Belgrade
Serbia	Clinical Hospital Center Bezanijska Kosa	Belgrade
Serbia	Endocrinology, Diabetes and Metabolism Diseases Clinic	Belgrade
Serbia	Endocrinology, Diabetes and Metabolism Diseases Clinic	Belgrade
Serbia	Clinical Centre Kragujevac, Internal Diseases Clinic, Endocr	Kragujevac
Serbia	Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department	Kragujevac
Serbia	Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.	Novi Sad	Vojvodina
Slovakia	DIADA s.r.o.	Bardejov
Slovakia	Diabetologicka ambulancia DIOLI s.r.o.	Kosice
Slovakia	DIOLI s.r.o.	Kosice
Slovakia	MediVet s.r.o.	Malacky
Slovakia	DIALIPID, s.r.o.	Presov
Slovakia	DIALIPID, s.r.o.	Presov
Slovakia	MUDr. Jan Culak, s.r.o.	Prievidza
Slovakia	DIACENTRUM, s.r.o.	Ruzomberok
Slovakia	DIACENTRUM, s.r.o.	Ruzomberok
Slovakia	MEDI-DIA s.r.o.	Sabinov
Slovakia	MEDI-DIA s.r.o.	Sabinov
Slovakia	DEImedi, s. r. o.	Surany
Slovakia	DEImedi, s. r. o.	Surany
Slovakia	ARETEUS s.r.o.	Trebisov
Slovakia	ARETEUS s.r.o.	Trebisov
Slovakia	iDia s. r. o.	Ziar nad Hronom
Slovakia	iDia s. r. o.	Ziar nad Hronom
Slovenia	Healthcare centre Kocevje	Kocevje
Slovenia	Healthcare Centre Koper	Koper
Slovenia	Dermatologija Bartenjev	Ljubljana
Slovenia	UKC Ljubljana, Endocrinology and Diabetes	Ljubljana
Slovenia	UKC Maribor - diabetes	Maribor
Slovenia	Healtcare Centre Nova Gorica	Nova Gorica
Slovenia	General Hospital Nova Gorica_Diabetes	Sempeter pri Gorici
Slovenia	Hospital Topolšica	Topolšica
South Africa	Newtown Clinical Research	Johannesburg	Gauteng
South Africa	Sandton Medical Research	Johannesburg	Gauteng
South Africa	Clinresco Centres (Pty) Ltd	Kempton Park	Gauteng
South Africa	Paarl Research Centre	Paarl	Western Cape
South Africa	Phoenix Pharma	Port Elizabeth	Eastern Cape
South Africa	Clinical Trial Systems (CTC)	Pretoria	Gauteng
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Complejo Hospitalario Universitario A Coruña	La Coruña
Spain	ABS La Roca del Vallés	La Roca del Vallés
Spain	Hospital Universitario de Móstoles	Móstoles
Spain	Hospital Son Llatzer	Palma de Mallorca
Spain	Hospital General de Segovia	Segovia
Spain	Hospital Infanta Luisa	Sevilla
Spain	Hospital La Fe - Endocrinología y Nutrición	Valencia
Sweden	CTC EbbePark Linköping	Linköping
Sweden	Clemenstorgets Hjärtmottagning	Lund
Sweden	Endokrinologkliniken	Lund
Sweden	Forskningsmottagning Internmedicin (tidigare KFE)	Malmö
Sweden	CTC GoCo Mölndal	Mölndal
Sweden	Överviktsenheten Örebro universitetssjukhus	Örebro
Sweden	Karolinska Universitetssjukhuset Solna,FOU Tema Hjärta Kärl	Stockholm
Taiwan	Changhua Christian Hospital	Changhua City
Taiwan	Taipei Medical University Hospital	Taipei city
Turkey	Cukurova Universitesi Tip Fakultesi	Adana
Turkey	Akdeniz University Tip Fakultesi Hastanesi	Antalya
Turkey	Eskisehir Osmangazi University School of Medicine	Eskisehir
Turkey	Basaksehir Cam ve Sakura Sehir Hastanesi	Istanbul
Turkey	Haseki Sultangazi	Istanbul
Turkey	Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji	Istanbul
Turkey	Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi	Istanbul
Turkey	T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital	Istanbul
Turkey	Recep Tayyip Erdogan Üni. Egitim ve Arastirma Hastanesi	Rize
Turkey	Tekirdag Namik Kemal UTF	Tekirdag
United Kingdom	Oldfield Surgery	Bath
United Kingdom	Oakenhurst Surgery	Blackburn
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Aberdeen Royal Infirmary	Foresterhill
United Kingdom	University Hospital Aintree	Liverpool
United Kingdom	Norfolk and Norwich University Hospital Trust	Norwich
United Kingdom	Pickering Medical Practice	Pickering
United Kingdom	Moorgreen Hospital	Southampton
United Kingdom	Lister Hospital	Stevenage	Hertfordshire
United Kingdom	Joint Clinical Research Facility - Swansea	Swansea
United Kingdom	Royal Cornwall Hospital (Treliske)	Truro
United States	Radiant Research Inc. - Akron	Akron	Ohio
United States	Albany Medical College - Endo	Albany	New York
United States	Velocity Clin Res Albuquerque	Albuquerque	New Mexico
United States	AnMed Health IMA	Anderson	South Carolina
United States	Synexus Clin Res US-Anderson	Anderson	South Carolina
United States	Velocity Clinical Res-Anderson	Anderson	South Carolina
United States	Arlington Family Res. Ctr Inc	Arlington	Texas
United States	Velocity Clin Res Austin	Austin	Texas
United States	Velocity Clinical Res-Banning	Banning	California
United States	UT Health University of Texas	Bellaire	Texas
United States	Synexus Clin Res-Birmingham	Birmingham	Alabama
United States	Univ of Alabama_Birmingham	Birmingham	Alabama
United States	St. Luke's Health System	Boise	Idaho
United States	Holston Medical Group Pc	Bristol	Tennessee
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Diabetes & Endo Specialists Inc	Chesterfield	Missouri
United States	Cedar-Crosse Research Center	Chicago	Illinois
United States	Velocity Clin Res-Chula Vista	Chula Vista	California
United States	Optumcare Colorado Springs	Colorado Springs	Colorado
United States	John Muir Physicians Network	Concord	California
United States	Hope Clin Res & Wellness	Conyers	Georgia
United States	Clinical Res Collaborative	Cumberland	Rhode Island
United States	Cedar Health Research	Dallas	Texas
United States	North Texas Endocrine Center	Dallas	Texas
United States	Synexus Clin Res Dallas	Dallas	Texas
United States	Velocity Clinical Res-Dallas	Dallas	Texas
United States	Aventiv Research	Dublin	Ohio
United States	Velocity Clin Res Providence	East Greenwich	Rhode Island
United States	Velocity Clin Res Syracuse	East Syracuse	New York
United States	Headlands Research California, LLC	Escondido	California
United States	Velocity Clin Res Gaffney	Gaffney	South Carolina
United States	Velocity Clin Res Gardena	Gardena	California
United States	St. Vincent Hosp-Prevea Health	Green Bay	Wisconsin
United States	PharmQuest Life Sciences LLC	Greensboro	North Carolina
United States	Velocity Clin Res Gulfport	Gulfport	Mississippi
United States	Clinical Invest Special_Gurnee	Gurnee	Illinois
United States	Pacific Diabetes & Endo Ctr	Honolulu	Hawaii
United States	Juno Research, LLC_Houston	Houston	Texas
United States	PlanIt Research, PLLC	Houston	Texas
United States	Synergy Groups Medical	Houston	Texas
United States	Northeast Research Institute	Jacksonville	Florida
United States	Medical Colleagues-Texas LLP	Katy	Texas
United States	Sante Clinical Research	Kerrville	Texas
United States	Holston Medical Group	Kingsport	Tennessee
United States	Velocity Clin Res San Diego	La Mesa	California
United States	Velocity Clin Res San Diego	La Mesa	California
United States	Velocity Clin Res Lafayette	Lafayette	Louisiana
United States	Arkansas Clinical Research	Little Rock	Arkansas
United States	Loma Linda Univ Hlth Cr Endo	Loma Linda	California
United States	East Coast Institute for Res	Macon	Georgia
United States	Urban Family Practice Assoc	Marietta	Georgia
United States	Solaris Clinical Research	Meridian	Idaho
United States	Bioclinical Research Alliance	Miami	Florida
United States	Clinical Trial Services Corp	Miami	Florida
United States	New Horizon Research Center	Miami	Florida
United States	South Broward Research LLC	Miramar	Florida
United States	Facey Medical Foundation	Mission Hills	California
United States	Discovery MMS Services, INC	Missouri City	Texas
United States	Carteret Medical Group	Morehead City	North Carolina
United States	Clinical Research Associates	Nashville	Tennessee
United States	BTC of New Bedford, LLC	New Bedford	Massachusetts
United States	TPMG Clinical Research	Newport News	Virginia
United States	Alliance for Multispec Res	Newton	Kansas
United States	Alliance for Multispec Res	Norman	Oklahoma
United States	West Orange Endocrinology	Ocoee	Florida
United States	Optimal Research Sites	Orange City	Florida
United States	AdventHealth Diab Inst	Orlando	Florida
United States	Synexus Clin Res - Orlando	Orlando	Florida
United States	Oviedo Medical Research, LLC	Oviedo	Florida
United States	Desert Oasis Hlthcr Med Group	Palm Springs	California
United States	Velocity Clin Res - Panorama	Panorama City	California
United States	Cahaba Research	Pelham	Alabama
United States	Synexus Cln Rsrch /Cnt Phoenix Med C	Phoenix	Arizona
United States	Velocity Clinical Research-Phoenix	Phoenix	Arizona
United States	Rainier Clin Res Ctr Inc	Renton	Washington
United States	Endocrine Research Solutions	Roswell	Georgia
United States	Endocrine Research Solutions, Inc.	Roswell	Georgia
United States	AES San Antonio	San Antonio	Texas
United States	NE Clin Res of San Antonio	San Antonio	Texas
United States	Univ Of Texas Hlth Science Cntr	San Antonio	Texas
United States	Linda Vista Health Care Ctr	San Diego	California
United States	Diabetes & Endo Treatment Spec	Sandy	Utah
United States	Velocity Clin Res Santa Ana	Santa Ana	California
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Hillcrest Clinical Research	Simpsonville	South Carolina
United States	Evanston Premier Hlthcr Res	Skokie	Illinois
United States	NorthShore Univ Hlth Sys	Skokie	Illinois
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	Velocity Clin Res Spartanburg	Spartanburg	South Carolina
United States	Piedmont Healthcare/Research	Statesville	North Carolina
United States	Premier Medical Center, Inc.	Toluca Lake	California
United States	DM Clin Rsrch/Fam Diag Clinic	Tomball	Texas
United States	Cotton-O'Neil Diab & Endo Ctr	Topeka	Kansas
United States	Premier Research Inc.	Trenton	New Jersey
United States	Iowa Diabetes & Endo Res Ctr	West Des Moines	Iowa
United States	Velocity Clin Res-Salt Lk City	West Jordan	Utah
United States	Southgate Medical Group, LLP	West Seneca	New York
United States	Great Lakes Medical Research	Westfield	New York
United States	Accellacare	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Bulgaria,  Canada,  China,  Colombia,  Croatia,  Czechia,  Denmark,  Finland,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Poland,  Romania,  Serbia,  Slovakia,  Slovenia,  South Africa,  Spain,  Sweden,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Change in glycated haemoglobin (HbA1c)	Measured in percentage-points.	From baseline (week 0) to end of treatment (week 68)
Primary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Relative change in body weight	Measured in percentage.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg: Change in HbA1c	Measured in percentage-points.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg: Relative change in body weight	Measured in percentage.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema 2.4 mg/2.4 mg versus semaglutide 1.0 mg: Change in HbA1c	Measured in percentage-points.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema 2.4 mg/2.4 mg versus semaglutide 1.0 mg: Relative change in body weight	Measured in percentage.	From baseline (week 0) to end of treatment (week 68)
Secondary	Cagrilintide 2.4 mg versus placebo: Change in HbA1c	Measured in percentage-points.	From baseline (week 0) to end of treatment (week 68)
Secondary	Cagrilintide 2.4 mg versus placebo: Relative change in body weight	Measured in percentage.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of greater than or equal to (>=) 10 percent (%) weight reduction	Measured as count of participants.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of >= 15 % weight reduction	Measured as count of participants.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of >= 20 % weight reduction	Measured as count of participants.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Change in time in Tight Target Range (TITR) 3.9-7.8 millimoles per litre (mmol/L) (70-140 milligrams per decilitre [mg/dL])	Measured in percentage-points.	From baseline (week -3) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Systolic Blood Pressure (SBP)	Measured in millimeters of mercury (mmHg).	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in triglycerides	Measured as ratio of triglycerides.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in non-High Density Lipoprotein (HDL) cholesterols	Measured as ratio of non-HDL cholesterol.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Change in Time In Range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL)	Measured in percentage-points.	From baseline (week -3) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in high sensitivity C-Reactive Protein (hsCRP)	Measured as ratio of hsCRP.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Fasting Plasma Glucose (FPG)	Measured in mmol/L.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol])	Measured as count of participants.	At end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of HbA1c target values of less than or equal to (=)6.5% (=48 mmol/mol)	Measured as count of participants.	At end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Change in time above range, >10.0 mmol/L (>180 mg/dL)	Measured in percentage-points.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Change in time above range, >13.9 mmol/L (>250 mg/dL)	Measured in percentage-points.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Within-day glycaemic variability (% coefficient of variation [CV])	Measured in percentage.	At end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Achievement of = 5 % weight reduction	Measured as count of participants.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in waist circumference	Measured in centimetre.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Diastolic Blood Pressure (DBP)	Measured in mmHg.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in total cholesterol	Measured as ratio of total cholesterol.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in HDL cholesterol	Measured as ratio of HDL cholesterol.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in low-density lipoprotein (LDL) cholesterol	Measured as ratio of LDL cholesterol.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in very low-density lipoprotein (VLDL) cholesterol	Measured as ratio of VLDL.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in free fatty acids	Measured as ratio of free fatty acids.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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.	From baseline (week 0) to end of treatment (week 68)
Secondary	CagriSema (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: Number of treatment emergent adverse events (TEAEs)	Measured as count of events.	From baseline (week 0) to end of study (week 75)
Secondary	CagriSema (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter)	Measured as count of episodes.	From baseline (week 0) to end of study (week 75)
Secondary	CagriSema (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: 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.	From baseline (week 0) to end of study (week 75)