A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight (REDEFINE 1)

May 3, 2026 updated by: Novo Nordisk A/S

Efficacy and Safety of Cagrilintide s.c. 2.4 Milligram (mg) in Combination With Semaglutide Subcutaneous (s.c). 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly in Participants With Overweight or Obesity

This study has 2 parts: First part is the main study and second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms.

Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 years.

Study Overview

Status

Active, not recruiting

Conditions

Obesity

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3400

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 Locations

Argentina
- - CABA, Argentina, C1060ABA
    - Centro de Investigacion Clinica
  - CABA, Argentina, C1120AAC
    - Centro Medico Viamonte SRL
  - CABA, Argentina, C1060ABA
    - CEDIC Centro de Investigación Clínica
  - Ciudad de Buenos Aires, Argentina, C1204AAD
    - Instituto Centenario
  - Santiago del Estero, Argentina, G4200
    - Sanatorio Norte
- La Pampa Province
  - Santa Rosa, La Pampa Province, Argentina, 6300
    - Fundación CESIM
Australia
- New South Wales
  - Brookvale, New South Wales, Australia, 2100
    - Northern Beaches Clinical Research
  - Charlestown, New South Wales, Australia, 2290
    - Novatrials
  - Darlinghurst, New South Wales, Australia, 2010
    - Momentum Clinical Research Darlinghurst
- Queensland
  - Taringa, Queensland, Australia, 4068
    - Momentum Clinical Research Taringa
Belgium
- - Bonheiden, Belgium, 2820
    - Imeldaziekenhuis - Bonheiden - Department of Endocrinology
  - Boussu, Belgium, 7300
    - CHR Mons-Hainaut - Site Warquignies
  - Brussels, Belgium, 1200
    - Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie
  - Edegem, Belgium, 2650
    - UZA - UZ Antwerpen - Department of Endocrinology
  - Edegem, Belgium, 2650
    - UZ Antwerpen - UZA - Department of Endocrinology
  - Ghent, Belgium, 9000
    - UZ Gent - Endocrinologie
  - Leuven, Belgium, 3000
    - UZ Leuven - Endocrinology
  - Mons, Belgium, 7000
    - CHU Helora - Hôpital de Mons - Site Constantinople
Bulgaria
- - Blagoevgrad, Bulgaria, 2700
    - MHAT Puls AD, Department of Internal Diseases
  - Montana, Bulgaria, 3400
    - OCIPSOMC - Endocrinology NT EOOD
  - Pleven, Bulgaria, 5800
    - OCSOMCE - Dr. Albena Dinkova EOOD
  - Plovdiv, Bulgaria, 4006
    - DCC Iztok EOOD
  - Rousse, Bulgaria, 7002
    - ASOMCEM - Individual Practice - Dr. Antoanela Slavcheva
  - Rousse, Bulgaria, 7002
    - ASOMCEM - IP - Dr. Antoanela Slavcheva
  - Smolyan, Bulgaria, 4700
    - Nader Yabrudi - ASMPVBE Individual practice
  - Sofia, Bulgaria, 1431
    - USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology
  - Sofia, Bulgaria, 1517
    - DCC XVIII - Sofia EOOD
  - Sofia, Bulgaria, 1431
    - USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology
  - Sofia, Bulgaria, 1618
    - DCC XX - Sofia EOOD, Endocrinology
  - Sofia, Bulgaria, 1431
    - UMHAT Aleksandrovska EAD, Densitometry and Bone Metabolic Diseases
  - Sofia, Bulgaria, 1431
    - USHATE Acad. Ivan Penchev EAD, First Clinic of Endocrinology
  - Sofia, Bulgaria, 1527
    - UMHAT Tsaritsa Yoanna - ISUL EAD, Endocrinology
  - Varna, Bulgaria, 9020
    - AIPSMC Dr. Artin Magardichyan EOOD
  - Yambol, Bulgaria, 8600
    - MC Berbatov EOOD, Cherni Drin
- Kyustendil
  - Dupnitsa, Kyustendil, Bulgaria, 2600
    - Medical centre Asclepius OOD
Canada
- Alberta
  - Edmonton, Alberta, Canada, T6H 2L4
    - C-endo Diab & Endo Clinic
  - Sherwood Park, Alberta, Canada, T8H 0N2
    - Synergy Wellness Clinic
- British Columbia
  - Surrey, British Columbia, Canada, V3Z 2N6
    - Ocean West Research Clinic
  - Victoria, British Columbia, Canada, V8V 4A1
    - Dr. M.B. Jones Inc
- New Brunswick
  - Moncton, New Brunswick, Canada, E1G 1A7
    - G.A. Research Associates Ltd.
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - Nova Scotia Hlth Halifax
- Ontario
  - Hamilton, Ontario, Canada, L8M 1K7
    - Premier Clinical Trial Research Network (PCTRN)
Denmark
- - Aarhus N, Denmark, 8200
    - Aarhus Universitetshospital Diabetes og Hormonsygdomme
  - Hellerup, Denmark, 2900
    - Center for Klinisk Metabolisk Forskning
  - Hellerup, Denmark, 2900
    - Gentofte Hospital - Center for Klinisk Metabolisk Forskning
  - Hvidovre, Denmark, 2650
    - Hvidovre Hospital Endokrinologisk forsknings afsnit 159
  - Køge, Denmark, 4600
    - Sjællands Universitetshospital
- Region Sjælland
  - Køge, Region Sjælland, Denmark, 4600
    - Sjællands Universitetshospital, Køge - Medicinsk Afdeling
- Region Syddanmark
  - Esbjerg, Region Syddanmark, Denmark, 6700
    - Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden
Finland
- - Helsinki, Finland, 00290
    - HUS Clinical Research Obesity Unit CRC
  - Kuopio, Finland, 70600
    - Health Step Finland Oy
  - Oulu, Finland, 90220
    - OYS - Sisätautien tutkimusyksikkö
  - Turku, Finland, 20520
    - Turku University Hospital
France
- - Paris, France, 75013
    - APHP - LA PITIE SALPETRIERE _ Service de Nutrition
  - Pierre-Bénite, France, 69310
    - Hospices Civils de Lyon-Hopital Lyon Sud
  - Saint-Herblain, France, 44800
    - Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec
  - Strasbourg, France, 67098
    - Les Hopitaux Universitaires de Strasbourg-Hopital de Hautepierre
  - Vénissieux, France, 69200
    - Centre de Recherche Clinique Portes Du Sud
Germany
- - Bad Mergentheim, Germany, 97980
    - Diabetespraxis Mergentheim
  - Elsterwerda, Germany, 04910
    - Zentrum für klinische Studien Südbrandenburg GmbH
  - Essen, Germany, 45136
    - InnoDiab Forschung GmbH
  - Hamburg, Germany, 22607
    - Wendisch - Dahl Hamburg - DZHW
  - Leipzig, Germany, 04107
    - AmBeNet GmbH
  - Leipzig, Germany, 04103
    - Uniklinik Leipzig - Klinik und Poliklinik für Endokrinologie, Nephrologie, Rheumatologie
  - Münster, Germany, 48145
    - Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
  - Stuttgart, Germany, 70378
    - MZM Praxis Drs. Erlinger
  - Wangen, Germany, 88239
    - Zentrum für klinische Studien Allgäu Oberschwaben
India
- - Delhi, India, 110029
    - All India Institute of Medical Sciences_New Dehli
  - Hyderabad, India, 500012
    - Osmania General Hospital
- Gujarat
  - Surat, Gujarat, India, 395002
    - Nirmal Hospital Pvt. Ltd.
- Karnataka
  - Belagavi, Karnataka, India, 590001
    - Belgaum Diabetes Centre
- Kerala
  - Kozhikode, Kerala, India, 673008
    - Government Medical College, Kozhikode
- Maharashtra
  - Mumbai, Maharashtra, India, 400004
    - Sir H. N. Reliance Foundation Hospital and Research Centre
  - Mumbai, Maharashtra, India, 400011
    - Wockhardt Hospital, Mumbai Central
  - Nagpur, Maharashtra, India, 440009
    - Government Medical College and Super Speciality Hospital, Nagpur
  - Pune, Maharashtra, India, 411004
    - Deenanath Mangeshkar Hospital & Research Centre
  - Pune, Maharashtra, India, 411004
    - Sahyadri Super Speciality Hospital
  - Pune, Maharashtra, India, 411001
    - Grant Medical foundation Ruby Hall Clinic
  - Pune, Maharashtra, India, 411021
    - Chellaram Diabetes Institute
  - Pune, Maharashtra, India, 411021
    - chelleram Diabetes Institute
- New Delhi
  - Delhi, New Delhi, India, 110002
    - Maulana Azad Medical College
- Punjab
  - Chandigarh, Punjab, India, 160012
    - Post Graduate Institute of Medical Education & Research_Chandigarh
- Rajasthan
  - Jaipur, Rajasthan, India, 302004
    - SMS Medical College & Hospital
  - Jaipur, Rajasthan, India, 302017
    - Eternal Heart Care Centre
- Tamil Nadu
  - Vellore, Tamil Nadu, India, 632004
    - Christian Medical College Hospital, Vellore
- Telangana
  - Hyderabad, Telangana, India, 500032
    - AIG Hospitals,Hyderabad
Italy
- - Bologna, Italy, 40138
    - A.O.Universitaria S.ORSOLA-MALPIGHI - U.O.Endocrinologia e Cura
  - Catania, Italy, 95122
    - ARNAS Garibaldi Catania - Presidio Ospedaliero Garibaldi-Centro
  - Padova, Italy, 35128
    - Azienda Ospedaliera di Padova Clin.Med.3
  - Partinico, Italy, 90047
    - Ospedale Civico Partinico di Palermo
  - Roma, Italy, 00133
    - Policlinico Universitario Tor Vergata
  - Roma, Italy, 00161
    - AOU Policlinico Umberto I - Dip. Medicina Interna, Scienze endocrino-metaboliche e malattie infettive
- BA
  - Bari, BA, Italy, 70124
    - A.O.U. Consorziale Policlinico di Bari
- Cz
  - Catanzaro, Cz, Italy, 88100
    - Azienda Ospedaliero-Universitaria Renato Dulbecco
- Lombardy
  - San Donato Milanese (MI), Lombardy, Italy, 20097
    - Policlinico San Donato S.p.A.
- RM
  - Roma, RM, Italy, 00128
    - Pol. Uni. Campus Biomedico
- SI
  - Siena, SI, Italy, 53100
    - Azienda Ospedaliera Universitaria Senese
Japan
- - Aichi, Japan, 468-0009
    - TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
  - Chiba-shi, Chiba, Japan, 260-8677
    - Chiba University Hospital_Diabetes, Metabolism and Endocrinology
  - Gunma, Japan, 373-0036
    - Kawada Clinic
  - Kanagawa, Japan, 231-0023
    - Motomachi Takatsuka Naika Clinic_Internal Medicine
  - Osaka, Japan, 530-0001
    - Osaka NISHI-UMEDA Clinic_Internal Medicine
  - Saitama, Japan, 350-0851
    - Asano Clinic
  - Sendai-shi, Miyagi, Japan, 983-0039
    - Shinden Higashi Clinic_Internal medicine
  - Tokyo, Japan, 103-0027
    - Tokyo-Eki Center-building Clinic
  - Tokyo, Japan, 169-0072
    - Higashi-Shinjuku Clinic
  - Tokyo, Japan, 141-0032
    - Miho Clinic
  - Tokyo, Japan, 103-0027
    - Tokyo-Eki Center-building Clinic_Internal Medicine
  - Tokyo, Japan, 104-0031
    - Fukuwa Clinic_Internal Medicine
  - Tokyo, Japan, 160-0008
    - ToCROM Clinic_Internal Medicine
- Hokkaido
  - Sapporo, Hokkaido, Japan, 004-0004
    - Shinsapporo Seiryou Hospital_General Clinical Department
- Osaka
  - Suita-shi, Osaka, Japan, 565-0853
    - OCROM Clinic_Internal medicine
Mexico
- - Aguascalientes, Mexico, 20230
    - Centro de Investigación Cardiometabólica de Aguascalientes
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44670
    - Centro de Investigacion Clinica Endocrinologica de Jalisco
  - Guadalajara, Jalisco, Mexico, 44650
    - Consultorio Arechavaleta Granell María del Rosario
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64060
    - Cardiolink Clin Trials S.C.
  - Monterrey, Nuevo León, Mexico, 64020
    - Internal Medicine Clin Trials
Netherlands
- - Amsterdam, Netherlands, 1105 AZ
    - AmsterdamUMC AMC
  - Arnhem, Netherlands, 6815 AD
    - Rijnstate Ziekenhuis
  - Hoofddorp, Netherlands, 2134 TM
    - Spaarne Gasthuis Hoofddorp - Interne
  - Roosendaal, Netherlands, 4708 AE
    - Bravis Zkh Roosendaal
  - Zwijndrecht, Netherlands, 3331 LZ
    - Albert Schweitzer Zkh, Zwijndrecht - Interne
Poland
- - Krakow, Poland, 30-363
    - Centrum Medyczne Plejady
  - Legnica, Poland, 59-220
    - Beata Mikłaszewicz & Dariusz Dąbrowski "CARDIAMED" s.j.
  - Lublin, Poland, 20-333
    - Terpa Sp. z o.o. Sp. k.
  - Warsaw, Poland, 00-416
    - Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orłowskiego Centrum Medycznego Kształcenia Podyplomowego
  - Warsaw, Poland, 02-117
    - Instytut Diabetologii Sp. z o.o.
- Kujawsko-Pomorskie Voivodeship
  - Bydgoszcz, Kujawsko-Pomorskie Voivodeship, Poland, 85-107
    - 50BIO.COM Sp. z o.o.
- Kuyavian-Pomeranian Voivodeship
  - Bygdoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
    - Gierach-Med
- Lesser Poland Voivodeship
  - Krakow, Lesser Poland Voivodeship, Poland, 30-363
    - Centrum Medyczne Plejady
- Lower Silesian Voivodeship
  - Legnica, Lower Silesian Voivodeship, Poland, 59-220
    - Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.
- Lubelskie Voivodeship
  - Lublin, Lubelskie Voivodeship, Poland, 20-333
    - Terpa Sp. z o.o. Sp. k.
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 00-416
    - Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego Centrum Medycznego Ksztalcenia Podyplomowego
- Mazovian Voivodeship
  - Warsaw, Mazovian Voivodeship, Poland, 02-117
    - Instytut Diabetologii Sp. z o.o.
- Podlaskie Voivodeship
  - Bialystok, Podlaskie Voivodeship, Poland, 15-276
    - Uniwersytecki Szpital Kliniczny w Bialymstoku
  - Bialystok, Podlaskie Voivodeship, Poland, 15-281
    - Gabinet Leczenia Otylosci i Chorob Dietozaleznych
  - Bialystok, Podlaskie Voivodeship, Poland, 15-879
    - NZOZ Vita-Diabetica Malgorzata Buraczyk
- Pomeranian Voivodeship
  - Gdansk, Pomeranian Voivodeship, Poland, 80-214
    - Uniwersyteckie Centrum Kliniczne
- Slaskie Voivodeship
  - Katowice, Slaskie Voivodeship, Poland, 40-772
    - Centrum Medyczne Salvia
- Warmian-Masurian Voivodeship
  - Elblag, Warmian-Masurian Voivodeship, Poland, 82-300
    - Klinika Bellamed
- Wielkopolskie Voivodeship
  - Poznan, Wielkopolskie Voivodeship, Poland, 60-198
    - Centrum Ginekologii, Położnictwa i Leczenia Niepłodności
  - Poznan, Wielkopolskie Voivodeship, Poland, 60-198
    - Centrum Ginekologii, Poloznictwa i Leczenia Nieplodnosci
  - Poznan, Wielkopolskie Voivodeship, Poland, 60-589
    - Centrum Zdrowia Metabolicznego Paweł Bogdański
Serbia
- - Belgrade, Serbia, 11080
    - Clinical Hospital Center Bezanijska Kosa
  - Belgrade, Serbia, 11000
    - Endocrinology, Diabetes and Metabolism Diseases Clinic
  - Novi Sad, Serbia, 21000
    - Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
- Vojvodina
  - Novi Sad, Vojvodina, Serbia, 21000
    - Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
South Africa
- Gauteng
  - Benoni, Gauteng, South Africa, 1501
    - East Rand Physicians
  - Johannesburg, Gauteng, South Africa, 1812
    - Dr R Dulabh
  - Lenasia, Gauteng, South Africa, 1827
    - Dr Moosa's Rooms
  - Midrand, Gauteng, South Africa, 1685
    - Shop#1 Health Emporium
  - Pretoria, Gauteng, South Africa, 0184
    - Botho ke Bontle Health Services
- KwaZulu-Natal
  - Durban, KwaZulu-Natal, South Africa, 4450
    - Dr J Reddy
  - Durban, KwaZulu-Natal, South Africa, 4091
    - Dr Vawda's site
- North West
  - Brits, North West, South Africa, 0250
    - Armansis Medical Centre
- Western Cape
  - Cape Town, Western Cape, South Africa, 7708
    - Dr Hilton Kaplan
South Korea
- - Daegu, South Korea, 14233
    - Kyungpook National University Hospital
  - Daejeon, South Korea, 35233
    - Daejeon Eulji Medical Center, Eulji University
  - Incheon, South Korea, 21565
    - Gachon University Gil Medical Center
  - Seongnam-si, Gyeonggi-do, South Korea, 13620
    - Seoul National University Bundang Hospital
  - Seoul, South Korea, 03080
    - Seoul National University Hospital
  - Seoul, South Korea, 05505
    - Asan Medical Center
  - Seoul, South Korea, 06351
    - Samsung Medical Center
  - Seoul, South Korea, 03722
    - Severance Hospital, Yonsei University Health System
  - Yangsan, South Korea, 50612
    - Pusan National University Yangsan Hospital
- Gyeonggi-do
  - Bucheon-si, Gyeonggi-do, South Korea, 14647
    - The Catholic University of Korea, Bucheon St. Mary's Hospital
  - Bucheon-si, Gyeonggi-do, South Korea, 14647
    - The Catholic University of Korea, Bucheon St.Mary's Hospital
  - Seongnam-si, Gyeonggi-do, South Korea, 13620
    - Seoul National University Bundang Hospital
- Gyeongsangnam-do
  - Yangsan, Gyeongsangnam-do, South Korea, 50612
    - Pusan National University Yangsan Hospital
Spain
- - Barcelona, Spain, 08036
    - Hospital Clínic i Provincial
  - Castilleja de la Cuesta, Spain, 41950
    - Hospital Vithas Sevilla
  - León, Spain, 24008
    - Hospital de Leon
  - León, Spain, 24008
    - H. de León_Endocrinología
  - Madrid, Spain, 28007
    - Hospital Gregorio Marañón
  - Seville, Spain, 41003
    - Clínica Nuevas Tecnologías en Diabetes y Endocrinología
  - Seville, Spain, 41010
    - H. Infanta Luisa_Endocrino y Obesidad
- Navarre
  - Pamplona, Navarre, Spain, 31008
    - Clinica Universitaria de Navarra
Taiwan
- - Taichung, Taiwan, 404
    - China Medical University Hospital
  - Taipei, Taiwan, 100
    - National Taiwan University Hospital_main
Turkey (Türkiye)
- - Adana, Turkey (Türkiye), 01250
    - Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi
  - Adana, Turkey (Türkiye), 01060
    - Adana Şehir Eğitim ve Araştırma Hastanesi
  - Ankara, Turkey (Türkiye), 06800
    - Ankara Sehir Hastanesi Dahiliye Klinigi
  - Ankara, Turkey (Türkiye), 06800
    - Ankara Bilkent Şehir Hastanesi-Dahiliye
  - Antalya, Turkey (Türkiye), 07058
    - Akdeniz Üniversitesi Hastanesi- Endokrinoloji
  - Hatay, Turkey (Türkiye), 31060
    - Hatay Mustafa Kemal Universitesi Saglik Uygulama ve Arastirm
  - Istanbul, Turkey (Türkiye), 34390
    - Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji
  - Istanbul, Turkey (Türkiye), 34400
    - Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi- Endokrinoloji
  - Istanbul, Turkey (Türkiye), 34722
    - Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye
  - Istanbul, Turkey (Türkiye), 34668
    - Haydarpaşa Numune Eğitim ve Araştırma Hastanesi - Endokrinoloji
  - Istanbul, Turkey (Türkiye), 34390
    - İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Endokrinoloji
  - Sivas, Turkey (Türkiye), 58140
    - Sivas Cumhuriyet Univesity Endocrinology Department
  - Sivas, Turkey (Türkiye), 58140
    - Sivas Cumhuriyet Üniversitesi Hastanesi -Endokrinoloji
- Cankaya
  - Ankara, Cankaya, Turkey (Türkiye), 06800
    - Baskent University Ankara Hospital
  - Ankara, Cankaya, Turkey (Türkiye), 06800
    - Başkent Üniversitesi Ankara Hastanesi-Aile Hekimliği
- Istanbul
  - Sultangazi, Istanbul, Turkey (Türkiye), 34265
    - Haseki Egitim ve Arastirma Hastanesi
United Kingdom
- - Blackpool, United Kingdom, FY3 7EN
    - Layton Medical Centre
  - Bristol, United Kingdom, BS10 5NB
    - Southmead Hospital
  - Cambridge, United Kingdom, CB2 0QQ
    - Addenbrooke's Hospital_Cambridge
  - Chester, United Kingdom, CH2 1UL
    - Countess of Chester Hospital
  - Chippenham, United Kingdom, SN14 6GT
    - Hathaway Medical Centre
  - Coventry, United Kingdom, CV2 2DX
    - University Hospital Coventry - WISDEM Centre
  - Liverpool, United Kingdom, L9 7AL
    - Aintree University Hospital
  - Liverpool, United Kingdom, L9 7AL
    - University Hospital Aintree
  - London, United Kingdom, W12 0HS
    - Imperial College London
  - London, United Kingdom, SE1 9RT
    - Guy's Hospital - Diabetes
  - London, United Kingdom, WC1E 6JF
    - University College London - Obesity
  - Orpington, United Kingdom, BR6 8ND
    - Princess Royal University Hospital
  - Taunton, United Kingdom, TA1 5DA
    - Musgrove Park Hospital
- Kent
  - Orpington, Kent, United Kingdom, BR6 8ND
    - Princess Royal University Hospital
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - Univ of Alabama Birmingham
- California
  - Los Angeles, California, United States, 90057
    - Velocity Clin Res Wstlke
  - Los Angeles, California, United States, 90017
    - Velocity Clin Res Los Angeles
- Colorado
  - Aurora, Colorado, United States, 80045
    - Univ of Colorado at Denver
  - Golden, Colorado, United States, 80401
    - OptumCare Clinical Trials LLC
- Florida
  - Fleming Island, Florida, United States, 92003
    - Northeast Research Institute
  - Miramar, Florida, United States, 33027
    - South Broward Research LLC
  - Orlando, Florida, United States, 32825
    - Florida Inst For Clin Res
  - Orlando, Florida, United States, 32801
    - Clinical Neuroscience Solution
  - Plantation, Florida, United States, 33324
    - Clinical Trial Res Assoc,Inc
- Georgia
  - Conyers, Georgia, United States, 30094
    - Hope Clin Res & Wellness
- Hawaii
  - Honolulu, Hawaii, United States, 96814
    - East West Med Res Inst
- Illinois
  - Chicago, Illinois, United States, 60640
    - Great Lakes Clinical Trials
  - Skokie, Illinois, United States, 60077
    - Evanston Premier Hlthcr Res
  - Skokie, Illinois, United States, 60077
    - Endeavor Health
- Indiana
  - Indianapolis, Indiana, United States, 46260
    - Midwest Inst For Clin Res
- Michigan
  - Buckley, Michigan, United States, 49620
    - Northern Pines Hlth Ctr, PC
- Missouri
  - City of Saint Peters, Missouri, United States, 63303
    - StudyMetrix Research LLC
- New York
  - Binghamton, New York, United States, 13905
    - Velocity Clinical Research Binghamton
  - New York, New York, United States, 10021
    - Comprehensive Weight Ctrl Prog
- North Carolina
  - Chapel Hill, North Carolina, United States, 27514
    - University of North Carolina
  - Chapel Hill, North Carolina, United States, 27517
    - University of North Carolina
  - Greensboro, North Carolina, United States, 27408
    - PharmQuest Life Sciences LLC
  - Greensboro, North Carolina, United States, 27405
    - Medication Mgmnt, LLC_Grnsboro
  - Raleigh, North Carolina, United States, 27609
    - Accellacare_NC
  - Wilmington, North Carolina, United States, 28401
    - Accellacare
- Ohio
  - Wadsworth, Ohio, United States, 44281
    - New Venture Medical Research
- Oklahoma
  - Norman, Oklahoma, United States, 73072
    - Lynn Institute of Norman
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104-3317
    - The University of Penn Center
- Rhode Island
  - Cumberland, Rhode Island, United States, 02864
    - Clinical Res Collaborative
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Medical Uni of SC Charleston
  - North Charleston, South Carolina, United States, 29405
    - Coastal Carolina Res Ctr
  - Simpsonville, South Carolina, United States, 29681-1538
    - Hillcrest Clinical Research
  - Spartanburg, South Carolina, United States, 29303
    - Spartanburg Medical Research
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - Holston Medical Group_Bristol
  - Kingsport, Tennessee, United States, 37660
    - Holston Medical Group
- Texas
  - Dallas, Texas, United States, 75230
    - Velocity Clinical Res-Dallas
  - Dallas, Texas, United States, 75390-9302
    - UT Southwestern Med Cntr
  - Dallas, Texas, United States, 75226
    - Baylr Sctt White Rs Inst, Endo
  - Longview, Texas, United States, 75605
    - DCOL Ctr for Clin Res
- Virginia
  - Arlington, Virginia, United States, 22206
    - Washington Cntr Weight Mgmt
  - Newport News, Virginia, United States, 23606
    - Health Res of Hampton Roads
  - Winchester, Virginia, United States, 22601-3834
    - Selma Medical Associates
- Washington
  - Olympia, Washington, United States, 98502
    - Capital Clin Res Ctr,LLC
  - Renton, Washington, United States, 98057
    - Rainier Clin Res Ctr Inc

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

Child
Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Male or female
Age above or equal to 18 years at the time of signing informed consent
Body mass index (BMI) greater than or equal to 30.0 kilograms per square meter (kg/m^2) or b) BMI greater than or equal to 27.0 kg/m^2 with the presence of at least one weight-related comorbidity including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

Exclusion Criteria:

- Glycaemia related: a) Glycated Haemoglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening b) History of type 1 or type 2 diabetes mellitus

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

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo s.c. Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 68 weeks. Participants randomised to this arm will be included in the extension phase for 97 weeks.	Drug: Placebo semaglutide Participants will receive placebo matched to semaglutide. Drug: Placebo cagrilintide Participants will receive placebo matched to cagrilintide.
Experimental: Cagrisema Participants will receive cagrilintide and semaglutide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for 97 weeks.	Drug: Cagrilintide Cagrilintide will be administered subcutaneously. Drug: Semaglutide Participants will recieve semaglutide subcutaneously.
Active Comparator: Cagrilintide Participants will receive cagrilintide s.c. and placebo matching to semaglutide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeks.	Drug: Cagrilintide Cagrilintide will be administered subcutaneously. Drug: Placebo semaglutide Participants will receive placebo matched to semaglutide.
Active Comparator: Semaglutide Participants will receive semaglutide s.c.and placebo matched to cagrilintide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeks.	Drug: Semaglutide Participants will recieve semaglutide subcutaneously. Drug: Placebo cagrilintide Participants will receive placebo matched to cagrilintide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CagriSema versus placebo: Relative change in body weight Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in percentage (%)	From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Achievement of greater than or equal to (>=) 5% weight reduction Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured as count of participants	From baseline (week 0) to end of treatment (week 68)

Secondary Outcome Measures

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 1, 2022

Primary Completion (Actual)

October 30, 2024

Study Completion (Estimated)

October 19, 2026

Study Registration Dates

First Submitted

October 3, 2022

First Submitted That Met QC Criteria

October 3, 2022

First Posted (Actual)

October 5, 2022

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

NN9838-4608
Universal Trial Number (UTN) (Other Identifier: U1111-1261-1912)
2020-005435-75 (EudraCT Number)

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

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Obesity

Clinical Trials on Cagrilintide

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