A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
REDEFINE 1
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
3 other identifiers
interventional
3,400
23 countries
254
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started Nov 2022
Longer than P75 for phase_3 obesity
254 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2022
CompletedFirst Posted
Study publicly available on registry
October 5, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 19, 2026
ExpectedMay 5, 2026
May 1, 2026
2 years
October 3, 2022
May 3, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
CagriSema versus placebo: Relative change in body weight
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
Measured as count of participants
From baseline (week 0) to end of treatment (week 68)
Secondary Outcomes (65)
CagriSema versus placebo: Achievement of >= 20% weight reduction
From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Achievement of >= 25% weight reduction
From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Achievement of >= 30% weight reduction
From baseline (week 0) to end of treatment (week 68)
CagriSema versus cagrilintide and CagriSema versus semaglutide: Relative change in body weight
From baseline (week 0) to end of treatment (week 68)
CagriSema versus placebo: Relative change in body weight
From baseline (week 0) to week 8
- +60 more secondary outcomes
Study Arms (4)
Cagrisema
EXPERIMENTALParticipants 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.
Cagrilintide
ACTIVE COMPARATORParticipants 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.
Semaglutide
ACTIVE COMPARATORParticipants 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.
Placebo s.c.
PLACEBO COMPARATORParticipants 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.
Interventions
Participants will receive placebo matched to cagrilintide.
Participants will receive placebo matched to semaglutide.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (254)
Univ of Alabama Birmingham
Birmingham, Alabama, 35233, United States
Velocity Clin Res Los Angeles
Los Angeles, California, 90017, United States
Velocity Clin Res Wstlke
Los Angeles, California, 90057, United States
Univ of Colorado at Denver
Aurora, Colorado, 80045, United States
OptumCare Clinical Trials LLC
Golden, Colorado, 80401, United States
Northeast Research Institute
Fleming Island, Florida, 92003, United States
South Broward Research LLC
Miramar, Florida, 33027, United States
Clinical Neuroscience Solution
Orlando, Florida, 32801, United States
Florida Inst For Clin Res
Orlando, Florida, 32825, United States
Clinical Trial Res Assoc,Inc
Plantation, Florida, 33324, United States
Hope Clin Res & Wellness
Conyers, Georgia, 30094, United States
East West Med Res Inst
Honolulu, Hawaii, 96814, United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
Endeavor Health
Skokie, Illinois, 60077, United States
Evanston Premier Hlthcr Res
Skokie, Illinois, 60077, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, 46260, United States
Northern Pines Hlth Ctr, PC
Buckley, Michigan, 49620, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, 63303, United States
Velocity Clinical Research Binghamton
Binghamton, New York, 13905, United States
Comprehensive Weight Ctrl Prog
New York, New York, 10021, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
University of North Carolina
Chapel Hill, North Carolina, 27517, United States
Medication Mgmnt, LLC_Grnsboro
Greensboro, North Carolina, 27405, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, 27408, United States
Accellacare_NC
Raleigh, North Carolina, 27609, United States
Accellacare
Wilmington, North Carolina, 28401, United States
New Venture Medical Research
Wadsworth, Ohio, 44281, United States
Lynn Institute of Norman
Norman, Oklahoma, 73072, United States
The University of Penn Center
Philadelphia, Pennsylvania, 19104-3317, United States
Clinical Res Collaborative
Cumberland, Rhode Island, 02864, United States
Medical Uni of SC Charleston
Charleston, South Carolina, 29425, United States
Coastal Carolina Res Ctr
North Charleston, South Carolina, 29405, United States
Hillcrest Clinical Research
Simpsonville, South Carolina, 29681-1538, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
Holston Medical Group_Bristol
Bristol, Tennessee, 37620, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Baylr Sctt White Rs Inst, Endo
Dallas, Texas, 75226, United States
Velocity Clinical Res-Dallas
Dallas, Texas, 75230, United States
UT Southwestern Med Cntr
Dallas, Texas, 75390-9302, United States
DCOL Ctr for Clin Res
Longview, Texas, 75605, United States
Washington Cntr Weight Mgmt
Arlington, Virginia, 22206, United States
Health Res of Hampton Roads
Newport News, Virginia, 23606, United States
Selma Medical Associates
Winchester, Virginia, 22601-3834, United States
Capital Clin Res Ctr,LLC
Olympia, Washington, 98502, United States
Rainier Clin Res Ctr Inc
Renton, Washington, 98057, United States
Fundación CESIM
Santa Rosa, La Pampa Province, 6300, Argentina
CEDIC Centro de Investigación Clínica
CABA, C1060ABA, Argentina
Centro de Investigación Clínica
CABA, C1060ABA, Argentina
Centro Médico Viamonte SRL
CABA, C1120AAC, Argentina
Instituto Centenario
Ciudad de Buenos Aires, C1204AAD, Argentina
Sanatorio Norte
Santiago del Estero, G4200, Argentina
Northern Beaches Clinical Research
Brookvale, New South Wales, 2100, Australia
Novatrials
Charlestown, New South Wales, 2290, Australia
Momentum Clinical Research Darlinghurst
Darlinghurst, New South Wales, 2010, Australia
Momentum Clinical Research Taringa
Taringa, Queensland, 4068, Australia
Imeldaziekenhuis - Bonheiden - Department of Endocrinology
Bonheiden, 2820, Belgium
CHR Mons-Hainaut - Site Warquignies
Boussu, 7300, Belgium
Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie
Brussels, 1200, Belgium
UZ Antwerpen - UZA - Department of Endocrinology
Edegem, 2650, Belgium
UZA - UZ Antwerpen - Department of Endocrinology
Edegem, 2650, Belgium
UZ Gent - Endocrinologie
Ghent, 9000, Belgium
UZ Leuven - Endocrinology
Leuven, 3000, Belgium
CHU Helora - Hôpital de Mons - Site Constantinople
Mons, 7000, Belgium
Medical centre Asclepius OOD
Dupnitsa, Kyustendil, 2600, Bulgaria
MHAT Puls AD, Department of Internal Diseases
Blagoevgrad, 2700, Bulgaria
OCIPSOMC - Endocrinology NT EOOD
Montana, 3400, Bulgaria
OCSOMCE - Dr. Albena Dinkova EOOD
Pleven, 5800, Bulgaria
DCC Iztok EOOD
Plovdiv, 4006, Bulgaria
ASOMCEM - Individual Practice - Dr. Antoanela Slavcheva
Rousse, 7002, Bulgaria
ASOMCEM - IP - Dr. Antoanela Slavcheva
Rousse, 7002, Bulgaria
Nader Yabrudi - ASMPVBE Individual practice
Smolyan, 4700, Bulgaria
UMHAT Aleksandrovska EAD, Densitometry and Bone Metabolic Diseases
Sofia, 1431, Bulgaria
USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology
Sofia, 1431, Bulgaria
USHATE Acad. Ivan Penchev EAD, First Clinic of Endocrinology
Sofia, 1431, Bulgaria
USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology
Sofia, 1431, Bulgaria
DCC XVIII - Sofia EOOD
Sofia, 1517, Bulgaria
UMHAT Tsaritsa Yoanna - ISUL EAD, Endocrinology
Sofia, 1527, Bulgaria
DCC XX - Sofia EOOD, Endocrinology
Sofia, 1618, Bulgaria
AIPSMC Dr. Artin Magardichyan EOOD
Varna, 9020, Bulgaria
MC Berbatov EOOD, Cherni Drin
Yambol, 8600, Bulgaria
C-endo Diab & Endo Clinic
Edmonton, Alberta, T6H 2L4, Canada
Synergy Wellness Clinic
Sherwood Park, Alberta, T8H 0N2, Canada
Ocean West Research Clinic
Surrey, British Columbia, V3Z 2N6, Canada
Dr. M.B. Jones Inc
Victoria, British Columbia, V8V 4A1, Canada
G.A. Research Associates Ltd.
Moncton, New Brunswick, E1G 1A7, Canada
Nova Scotia Hlth Halifax
Halifax, Nova Scotia, B3H 1V7, Canada
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, L8M 1K7, Canada
Sjællands Universitetshospital, Køge - Medicinsk Afdeling
Køge, Region Sjælland, 4600, Denmark
Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden
Esbjerg, Region Syddanmark, 6700, Denmark
Aarhus Universitetshospital Diabetes og Hormonsygdomme
Aarhus N, 8200, Denmark
Center for Klinisk Metabolisk Forskning
Hellerup, 2900, Denmark
Gentofte Hospital - Center for Klinisk Metabolisk Forskning
Hellerup, 2900, Denmark
Hvidovre Hospital Endokrinologisk forsknings afsnit 159
Hvidovre, 2650, Denmark
Sjællands Universitetshospital
Køge, 4600, Denmark
HUS Clinical Research Obesity Unit CRC
Helsinki, 00290, Finland
Health Step Finland Oy
Kuopio, 70600, Finland
OYS - Sisätautien tutkimusyksikkö
Oulu, 90220, Finland
Turku University Hospital
Turku, 20520, Finland
APHP - LA PITIE SALPETRIERE _ Service de Nutrition
Paris, 75013, France
Hospices Civils de Lyon-Hopital Lyon Sud
Pierre-Bénite, 69310, France
Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec
Saint-Herblain, 44800, France
Les Hopitaux Universitaires de Strasbourg-Hopital de Hautepierre
Strasbourg, 67098, France
Centre de Recherche Clinique Portes Du Sud
Vénissieux, 69200, France
Diabetespraxis Mergentheim
Bad Mergentheim, 97980, Germany
Zentrum für klinische Studien Südbrandenburg GmbH
Elsterwerda, 04910, Germany
InnoDiab Forschung GmbH
Essen, 45136, Germany
Wendisch - Dahl Hamburg - DZHW
Hamburg, 22607, Germany
Uniklinik Leipzig - Klinik und Poliklinik für Endokrinologie, Nephrologie, Rheumatologie
Leipzig, 04103, Germany
AmBeNet GmbH
Leipzig, 04107, Germany
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
Münster, 48145, Germany
MZM Praxis Drs. Erlinger
Stuttgart, 70378, Germany
Zentrum für klinische Studien Allgäu Oberschwaben
Wangen, 88239, Germany
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat, 395002, India
Belgaum Diabetes Centre
Belagavi, Karnataka, 590001, India
Government Medical College, Kozhikode
Kozhikode, Kerala, 673008, India
Sir H. N. Reliance Foundation Hospital and Research Centre
Mumbai, Maharashtra, 400004, India
Wockhardt Hospital, Mumbai Central
Mumbai, Maharashtra, 400011, India
Government Medical College and Super Speciality Hospital, Nagpur
Nagpur, Maharashtra, 440009, India
Grant Medical Foundation Ruby Hall Clinic
Pune, Maharashtra, 411001, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, 411004, India
Sahyadri Super Speciality Hospital
Pune, Maharashtra, 411004, India
Chellaram Diabetes Institute
Pune, Maharashtra, 411021, India
chelleram Diabetes Institute
Pune, Maharashtra, 411021, India
Maulana Azad Medical College
Delhi, New Delhi, 110002, India
Post Graduate Institute of Medical Education & Research_Chandigarh
Chandigarh, Punjab, 160012, India
SMS Medical College & Hospital
Jaipur, Rajasthan, 302004, India
Eternal Heart Care Centre
Jaipur, Rajasthan, 302017, India
Christian Medical College Hospital, Vellore
Vellore, Tamil Nadu, 632004, India
AIG Hospitals,Hyderabad
Hyderabad, Telangana, 500032, India
All India Institute of Medical Sciences_New Dehli
Delhi, 110029, India
Osmania General Hospital
Hyderabad, 500012, India
A.O.U. Consorziale Policlinico di Bari
Bari, BA, 70124, Italy
Azienda Ospedaliero-Universitaria Renato Dulbecco
Catanzaro, Cz, 88100, Italy
Policlinico San Donato S.p.A.
San Donato Milanese (MI), Lombardy, 20097, Italy
Pol. Uni. Campus Biomedico
Roma, RM, 00128, Italy
Azienda Ospedaliera Universitaria Senese
Siena, SI, 53100, Italy
A.O.Universitaria S.ORSOLA-MALPIGHI - U.O.Endocrinologia e Cura
Bologna, 40138, Italy
ARNAS Garibaldi Catania - Presidio Ospedaliero Garibaldi-Centro
Catania, 95122, Italy
Azienda Ospedaliera di Padova Clin.Med.3
Padova, 35128, Italy
Ospedale Civico Partinico di Palermo
Partinico, 90047, Italy
Policlinico Universitario Tor Vergata
Roma, 00133, Italy
AOU Policlinico Umberto I - Dip. Medicina Interna, Scienze endocrino-metaboliche e malattie infettive
Roma, 00161, Italy
Shinsapporo Seiryou Hospital_General Clinical Department
Sapporo, Hokkaido, 004-0004, Japan
OCROM Clinic_Internal medicine
Suita-shi, Osaka, 565-0853, Japan
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
Aichi, 468-0009, Japan
Chiba University Hospital_Diabetes, Metabolism and Endocrinology
Chiba-shi, Chiba, 260-8677, Japan
Kawada Clinic
Gunma, 373-0036, Japan
Motomachi Takatsuka Naika Clinic_Internal Medicine
Kanagawa, 231-0023, Japan
Osaka NISHI-UMEDA Clinic_Internal Medicine
Osaka, 530-0001, Japan
Asano Clinic
Saitama, 350-0851, Japan
Shinden Higashi Clinic_Internal medicine
Sendai-shi, Miyagi, 983-0039, Japan
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, 103-0027, Japan
Tokyo-Eki Center-building Clinic
Tokyo, 103-0027, Japan
Fukuwa Clinic_Internal Medicine
Tokyo, 104-0031, Japan
Miho Clinic
Tokyo, 141-0032, Japan
ToCROM Clinic_Internal Medicine
Tokyo, 160-0008, Japan
Higashi-shinjuku clinic
Tokyo, 169-0072, Japan
Consultorio Arechavaleta Granell María del Rosario
Guadalajara, Jalisco, 44650, Mexico
Centro de Investigacion Clinica Endocrinologica de Jalisco
Guadalajara, Jalisco, 44670, Mexico
Internal Medicine Clin Trials
Monterrey, Nuevo León, 64020, Mexico
Cardiolink Clin Trials S.C.
Monterrey, Nuevo León, 64060, Mexico
Centro de Investigación Cardiometabólica de Aguascalientes
Aguascalientes, 20230, Mexico
AmsterdamUMC AMC
Amsterdam, 1105 AZ, Netherlands
Rijnstate Ziekenhuis
Arnhem, 6815 AD, Netherlands
Spaarne Gasthuis Hoofddorp - Interne
Hoofddorp, 2134 TM, Netherlands
Bravis Zkh Roosendaal
Roosendaal, 4708 AE, Netherlands
Albert Schweitzer Zkh, Zwijndrecht - Interne
Zwijndrecht, 3331 LZ, Netherlands
50BIO.COM Sp. z o.o.
Bydgoszcz, Kujawsko-Pomorskie Voivodeship, 85-107, Poland
Gierach-Med
Bygdoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland
Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship, 30-363, Poland
Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.
Legnica, Lower Silesian Voivodeship, 59-220, Poland
Terpa Sp. z o.o. Sp. k.
Lublin, Lubelskie Voivodeship, 20-333, Poland
Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego Centrum Medycznego Ksztalcenia Podyplomowego
Warsaw, Masovian Voivodeship, 00-416, Poland
Instytut Diabetologii Sp. z o.o.
Warsaw, Mazovian Voivodeship, 02-117, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Podlaskie Voivodeship, 15-276, Poland
Gabinet Leczenia Otylosci i Chorob Dietozaleznych
Bialystok, Podlaskie Voivodeship, 15-281, Poland
NZOZ Vita-Diabetica Malgorzata Buraczyk
Bialystok, Podlaskie Voivodeship, 15-879, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-214, Poland
Centrum Medyczne Salvia
Katowice, Slaskie Voivodeship, 40-772, Poland
Klinika Bellamed
Elblag, Warmian-Masurian Voivodeship, 82-300, Poland
Centrum Ginekologii, Poloznictwa i Leczenia Nieplodnosci
Poznan, Wielkopolskie Voivodeship, 60-198, Poland
Centrum Ginekologii, Położnictwa i Leczenia Niepłodności
Poznan, Wielkopolskie Voivodeship, 60-198, Poland
Centrum Zdrowia Metabolicznego Paweł Bogdański
Poznan, Wielkopolskie Voivodeship, 60-589, Poland
Centrum Medyczne Plejady
Krakow, 30-363, Poland
Beata Mikłaszewicz & Dariusz Dąbrowski "CARDIAMED" s.j.
Legnica, 59-220, Poland
Terpa Sp. z o.o. Sp. k.
Lublin, 20-333, Poland
Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orłowskiego Centrum Medycznego Kształcenia Podyplomowego
Warsaw, 00-416, Poland
Instytut Diabetologii Sp. z o.o.
Warsaw, 02-117, Poland
Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
Novi Sad, Vojvodina, 21000, Serbia
Endocrinology, Diabetes and Metabolism Diseases Clinic
Belgrade, 11000, Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, 11080, Serbia
Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
Novi Sad, 21000, Serbia
East Rand Physicians
Benoni, Gauteng, 1501, South Africa
Dr R Dulabh
Johannesburg, Gauteng, 1812, South Africa
Dr Moosa's Rooms
Lenasia, Gauteng, 1827, South Africa
Shop#1 Health Emporium
Midrand, Gauteng, 1685, South Africa
Botho ke Bontle Health Services
Pretoria, Gauteng, 0184, South Africa
Dr Vawda's site
Durban, KwaZulu-Natal, 4091, South Africa
Dr J Reddy
Durban, KwaZulu-Natal, 4450, South Africa
Armansis Medical Centre
Brits, North West, 0250, South Africa
Dr Hilton Kaplan
Cape Town, Western Cape, 7708, South Africa
The Catholic University of Korea, Bucheon ST. Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647, South Korea
The catholic university of Korea, Bucheon St.Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612, South Korea
Kyungpook National University Hospital
Daegu, 14233, South Korea
Daejeon Eulji Medical Center, Eulji University
Daejeon, 35233, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Pusan National University Yangsan Hospital
Yangsan, 50612, South Korea
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Clinic i Provincial
Barcelona, 08036, Spain
Hospital Vithas Sevilla
Castilleja de la Cuesta, 41950, Spain
H. de León_Endocrinología
León, 24008, Spain
Hospital de León
León, 24008, Spain
Hospital Gregorio Marañón
Madrid, 28007, Spain
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
Seville, 41003, Spain
H. Infanta Luisa_Endocrino y Obesidad
Seville, 41010, Spain
China Medical University Hospital
Taichung, 404, Taiwan
National Taiwan University Hospital_main
Taipei, 100, Taiwan
Baskent University Ankara Hospital
Ankara, Cankaya, 06800, Turkey (Türkiye)
Başkent Üniversitesi Ankara Hastanesi-Aile Hekimliği
Ankara, Cankaya, 06800, Turkey (Türkiye)
Haseki Egitim ve Arastirma Hastanesi
Sultangazi, Istanbul, 34265, Turkey (Türkiye)
Adana Şehir Eğitim ve Araştırma Hastanesi
Adana, 01060, Turkey (Türkiye)
Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi
Adana, 01250, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Dahiliye
Ankara, 06800, Turkey (Türkiye)
Ankara Sehir Hastanesi Dahiliye Klinigi
Ankara, 06800, Turkey (Türkiye)
Akdeniz Üniversitesi Hastanesi- Endokrinoloji
Antalya, 07058, Turkey (Türkiye)
Hatay Mustafa Kemal Universitesi Saglik Uygulama ve Arastirm
Hatay, 31060, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji
Istanbul, 34390, Turkey (Türkiye)
İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Endokrinoloji
Istanbul, 34390, Turkey (Türkiye)
Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi- Endokrinoloji
Istanbul, 34400, Turkey (Türkiye)
Haydarpaşa Numune Eğitim ve Araştırma Hastanesi - Endokrinoloji
Istanbul, 34668, Turkey (Türkiye)
Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye
Istanbul, 34722, Turkey (Türkiye)
Sivas Cumhuriyet Univesity Endocrinology Department
Sivas, 58140, Turkey (Türkiye)
Sivas Cumhuriyet Üniversitesi Hastanesi -Endokrinoloji
Sivas, 58140, Turkey (Türkiye)
Princess Royal University Hospital
Orpington, Kent, BR6 8ND, United Kingdom
Layton Medical Centre
Blackpool, FY3 7EN, United Kingdom
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
Addenbrooke's Hospital_Cambridge
Cambridge, CB2 0QQ, United Kingdom
Countess of Chester Hospital
Chester, CH2 1UL, United Kingdom
Hathaway Medical Centre
Chippenham, SN14 6GT, United Kingdom
University Hospital Coventry - WISDEM Centre
Coventry, CV2 2DX, United Kingdom
Aintree University Hospital
Liverpool, L9 7AL, United Kingdom
University Hospital Aintree
Liverpool, L9 7AL, United Kingdom
Guy's Hospital - Diabetes
London, SE1 9RT, United Kingdom
Imperial College London
London, W12 0HS, United Kingdom
University College London - Obesity
London, WC1E 6JF, United Kingdom
Princess Royal University Hospital
Orpington, BR6 8ND, United Kingdom
Musgrove Park Hospital
Taunton, TA1 5DA, United Kingdom
Related Publications (2)
Verma S, Bottcher M, Brown P, Dicker D, Rubino D, Sbraccia P, Sharma AM, Smedegaard L, Sorrig R, Garvey WT. CagriSema Reduces Blood Pressure in Adults With Overweight or Obesity: REDEFINE 1. Hypertension. 2026 Feb;83(2):e26055. doi: 10.1161/HYPERTENSIONAHA.125.26055. Epub 2025 Dec 2.
PMID: 41328546DERIVEDGarvey WT, Bluher M, Osorto Contreras CK, Davies MJ, Winning Lehmann E, Pietilainen KH, Rubino D, Sbraccia P, Wadden T, Zeuthen N, Wilding JPH; REDEFINE 1 Study Group. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2025 Aug 14;393(7):635-647. doi: 10.1056/NEJMoa2502081. Epub 2025 Jun 22.
PMID: 40544433DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2022
First Posted
October 5, 2022
Study Start
November 1, 2022
Primary Completion
October 30, 2024
Study Completion (Estimated)
October 19, 2026
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com