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ACTIVE NOT RECRUITING
NCT05567796
PHASE3

A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

3400

Start Date

2022-11-01

Completion Date

2026-10-19

Last Updated

2026-03-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

Cagrilintide

Cagrilintide will be administered subcutaneously.

DRUG

Semaglutide

Participants will recieve semaglutide subcutaneously.

DRUG

Placebo cagrilintide

Participants will receive placebo matched to cagrilintide.

DRUG

Placebo semaglutide

Participants will receive placebo matched to semaglutide.

Locations (254)

Univ of Alabama Birmingham

Birmingham, Alabama, United States

Velocity Clin Res Los Angeles

Los Angeles, California, United States

Velocity Clin Res Wstlke

Los Angeles, California, United States

Univ of Colorado at Denver

Aurora, Colorado, United States

OptumCare Clinical Trials LLC

Golden, Colorado, United States

Northeast Research Institute

Fleming Island, Florida, United States

South Broward Research LLC

Miramar, Florida, United States

Clinical Neuroscience Solution

Orlando, Florida, United States

Florida Inst For Clin Res

Orlando, Florida, United States

Clinical Trial Res Assoc,Inc

Plantation, Florida, United States

Hope Clin Res & Wellness

Conyers, Georgia, United States

East West Med Res Inst

Honolulu, Hawaii, United States

Great Lakes Clinical Trials

Chicago, Illinois, United States

Endeavor Health

Skokie, Illinois, United States

Evanston Premier Hlthcr Res

Skokie, Illinois, United States

Midwest Inst For Clin Res

Indianapolis, Indiana, United States

Northern Pines Hlth Ctr, PC

Buckley, Michigan, United States

StudyMetrix Research LLC

City of Saint Peters, Missouri, United States

Velocity Clinical Research Binghamton

Binghamton, New York, United States

Comprehensive Weight Ctrl Prog

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Medication Mgmnt, LLC_Grnsboro

Greensboro, North Carolina, United States

PharmQuest Life Sciences LLC

Greensboro, North Carolina, United States

Accellacare_NC

Raleigh, North Carolina, United States

Accellacare

Wilmington, North Carolina, United States

New Venture Medical Research

Wadsworth, Ohio, United States

Lynn Institute of Norman

Norman, Oklahoma, United States

The University of Penn Center

Philadelphia, Pennsylvania, United States

Clinical Res Collaborative

Cumberland, Rhode Island, United States

Medical Uni of SC Charleston

Charleston, South Carolina, United States

Coastal Carolina Res Ctr

North Charleston, South Carolina, United States

Hillcrest Clinical Research

Simpsonville, South Carolina, United States

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Holston Medical Group_Bristol

Bristol, Tennessee, United States

Holston Medical Group

Kingsport, Tennessee, United States

Baylr Sctt White Rs Inst, Endo

Dallas, Texas, United States

Velocity Clinical Res-Dallas

Dallas, Texas, United States

UT Southwestern Med Cntr

Dallas, Texas, United States

DCOL Ctr for Clin Res

Longview, Texas, United States

Washington Cntr Weight Mgmt

Arlington, Virginia, United States

Health Res of Hampton Roads

Newport News, Virginia, United States

Selma Medical Associates

Winchester, Virginia, United States

Capital Clin Res Ctr,LLC

Olympia, Washington, United States

Rainier Clin Res Ctr Inc

Renton, Washington, United States

Fundación CESIM

Santa Rosa, La Pampa Province, Argentina

CEDIC Centro de Investigación Clínica

CABA, Argentina

Centro de Investigación Clínica

CABA, Argentina

Centro Médico Viamonte SRL

CABA, Argentina

Instituto Centenario

Ciudad de Buenos Aires, Argentina

Sanatorio Norte

Santiago del Estero, Argentina

Northern Beaches Clinical Research

Brookvale, New South Wales, Australia

Novatrials

Charlestown, New South Wales, Australia

Momentum Clinical Research Darlinghurst

Darlinghurst, New South Wales, Australia

Momentum Clinical Research Taringa

Taringa, Queensland, Australia

Imeldaziekenhuis - Bonheiden - Department of Endocrinology

Bonheiden, Belgium

CHR Mons-Hainaut - Site Warquignies

Boussu, Belgium

Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie

Brussels, Belgium

UZ Antwerpen - UZA - Department of Endocrinology

Edegem, Belgium

UZA - UZ Antwerpen - Department of Endocrinology

Edegem, Belgium

UZ Gent - Endocrinologie

Ghent, Belgium

UZ Leuven - Endocrinology

Leuven, Belgium

CHU Helora - Hôpital de Mons - Site Constantinople

Mons, Belgium

Medical centre Asclepius OOD

Dupnitsa, Kyustendil, Bulgaria

MHAT Puls AD, Department of Internal Diseases

Blagoevgrad, Bulgaria

OCIPSOMC - Endocrinology NT EOOD

Montana, Bulgaria

OCSOMCE - Dr. Albena Dinkova EOOD

Pleven, Bulgaria

DCC Iztok EOOD

Plovdiv, Bulgaria

ASOMCEM - Individual Practice - Dr. Antoanela Slavcheva

Rousse, Bulgaria

ASOMCEM - IP - Dr. Antoanela Slavcheva

Rousse, Bulgaria

Nader Yabrudi - ASMPVBE Individual practice

Smolyan, Bulgaria

UMHAT Aleksandrovska EAD, Densitometry and Bone Metabolic Diseases

Sofia, Bulgaria

USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology

Sofia, Bulgaria

USHATE Acad. Ivan Penchev EAD, First Clinic of Endocrinology

Sofia, Bulgaria

USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology

Sofia, Bulgaria

DCC XVIII - Sofia EOOD

Sofia, Bulgaria

UMHAT Tsaritsa Yoanna - ISUL EAD, Endocrinology

Sofia, Bulgaria

DCC XX - Sofia EOOD, Endocrinology

Sofia, Bulgaria

AIPSMC Dr. Artin Magardichyan EOOD

Varna, Bulgaria

MC Berbatov EOOD, Cherni Drin

Yambol, Bulgaria

C-endo Diab & Endo Clinic

Edmonton, Alberta, Canada

Synergy Wellness Clinic

Sherwood Park, Alberta, Canada

Ocean West Research Clinic

Surrey, British Columbia, Canada

Dr. M.B. Jones Inc

Victoria, British Columbia, Canada

G.A. Research Associates Ltd.

Moncton, New Brunswick, Canada

Nova Scotia Hlth Halifax

Halifax, Nova Scotia, Canada

Premier Clinical Trial Research Network (PCTRN)

Hamilton, Ontario, Canada

Sjællands Universitetshospital, Køge - Medicinsk Afdeling

Køge, Region Sjælland, Denmark

Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden

Esbjerg, Region Syddanmark, Denmark

Aarhus Universitetshospital Diabetes og Hormonsygdomme

Aarhus N, Denmark

Center for Klinisk Metabolisk Forskning

Hellerup, Denmark

Gentofte Hospital - Center for Klinisk Metabolisk Forskning

Hellerup, Denmark

Hvidovre Hospital Endokrinologisk forsknings afsnit 159

Hvidovre, Denmark

Sjællands Universitetshospital

Køge, Denmark

HUS Clinical Research Obesity Unit CRC

Helsinki, Finland

Health Step Finland Oy

Kuopio, Finland

OYS - Sisätautien tutkimusyksikkö

Oulu, Finland

Turku University Hospital

Turku, Finland

APHP - LA PITIE SALPETRIERE _ Service de Nutrition

Paris, France

Hospices Civils de Lyon-Hopital Lyon Sud

Pierre-Bénite, France

Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec

Saint-Herblain, France

Les Hopitaux Universitaires de Strasbourg-Hopital de Hautepierre

Strasbourg, France

Centre de Recherche Clinique Portes Du Sud

Vénissieux, France

Diabetespraxis Mergentheim

Bad Mergentheim, Germany

Zentrum fuer klinische Studien Suedbrandenburg GmbH

Elsterwerda, Germany

InnoDiab Forschung GmbH

Essen, Germany

Wendisch - Dahl Hamburg - DZHW

Hamburg, Germany

Uniklinik Leipzig - Klinik und Poliklinik für Endokrinologie, Nephrologie, Rheumatologie

Leipzig, Germany

AmBeNet GmbH

Leipzig, Germany

Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

Münster, Germany

MZM Praxis Drs. Erlinger

Stuttgart, Germany

Zentrum für klinische Studien Allgäu Oberschwaben

Wangen, Germany

Nirmal Hospital Pvt. Ltd.

Surat, Gujarat, India

Belgaum Diabetes Centre

Belagavi, Karnataka, India

Government Medical College, Kozhikode

Kozhikode, Kerala, India

Sir H. N. Reliance Foundation Hospital and Research Centre

Mumbai, Maharashtra, India

Wockhardt Hospital, Mumbai Central

Mumbai, Maharashtra, India

Government Medical College and Super Speciality Hospital, Nagpur

Nagpur, Maharashtra, India

Grant Medical Foundation Ruby Hall Clinic

Pune, Maharashtra, India

Deenanath Mangeshkar Hospital & Research Centre

Pune, Maharashtra, India

Sahyadri Super Speciality Hospital

Pune, Maharashtra, India

Chellaram Diabetes Institute

Pune, Maharashtra, India

chelleram Diabetes Institute

Pune, Maharashtra, India

Maulana Azad Medical College

Delhi, New Delhi, India

Post Graduate Institute of Medical Education & Research_Chandigarh

Chandigarh, Punjab, India

SMS Medical College & Hospital

Jaipur, Rajasthan, India

Eternal Heart Care Centre

Jaipur, Rajasthan, India

Christian Medical College Hospital, Vellore

Vellore, Tamil Nadu, India

AIG Hospitals,Hyderabad

Hyderabad, Telangana, India

All India Institute of Medical Sciences_New Dehli

Delhi, India

Osmania General Hospital

Hyderabad, India

A.O.U. Consorziale Policlinico di Bari

Bari, BA, Italy

Azienda Ospedaliero-Universitaria Renato Dulbecco

Catanzaro, Cz, Italy

Policlinico San Donato S.p.A.

San Donato Milanese (MI), Lombardy, Italy

Pol. Uni. Campus Biomedico

Roma, RM, Italy

Azienda Ospedaliera Universitaria Senese

Siena, SI, Italy

A.O.Universitaria S.ORSOLA-MALPIGHI - U.O.Endocrinologia e Cura

Bologna, Italy

ARNAS Garibaldi Catania - Presidio Ospedaliero Garibaldi-Centro

Catania, Italy

Azienda Ospedaliera di Padova Clin.Med.3

Padova, Italy

Ospedale Civico Partinico di Palermo

Partinico, Italy

Policlinico Universitario Tor Vergata

Roma, Italy

AOU Policlinico Umberto I - Dip. Medicina Interna, Scienze endocrino-metaboliche e malattie infettive

Roma, Italy

Shinsapporo Seiryou Hospital_General Clinical Department

Sapporo, Hokkaido, Japan

OCROM Clinic_Internal medicine

Suita-shi, Osaka, Japan

TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

Aichi, Japan

Chiba University Hospital_Diabetes, Metabolism and Endocrinology

Chiba-shi, Chiba, Japan

Kawada Clinic

Gunma, Japan

Motomachi Takatsuka Naika Clinic_Internal Medicine

Kanagawa, Japan

Osaka NISHI-UMEDA Clinic_Internal Medicine

Osaka, Japan

Asano Clinic

Saitama, Japan

Shinden Higashi Clinic_Internal medicine

Sendai-shi, Miyagi, Japan

Tokyo-Eki Center-building Clinic_Internal Medicine

Tokyo, Japan

Tokyo-Eki Center-building Clinic

Tokyo, Japan

Fukuwa Clinic_Internal Medicine

Tokyo, Japan

Miho Clinic

Tokyo, Japan

ToCROM Clinic_Internal Medicine

Tokyo, Japan

Higashi-shinjuku clinic

Tokyo, Japan

Consultorio Arechavaleta Granell María del Rosario

Guadalajara, Jalisco, Mexico

Centro de Investigacion Clinica Endocrinologica de Jalisco

Guadalajara, Jalisco, Mexico

Internal Medicine Clin Trials

Monterrey, Nuevo León, Mexico

Cardiolink Clin Trials S.C.

Monterrey, Nuevo León, Mexico

Centro de Investigación Cardiometabólica de Aguascalientes

Aguascalientes, Mexico

AmsterdamUMC AMC

Amsterdam, Netherlands

Rijnstate Ziekenhuis

Arnhem, Netherlands

Spaarne Gasthuis Hoofddorp - Interne

Hoofddorp, Netherlands

Bravis Zkh Roosendaal

Roosendaal, Netherlands

Albert Schweitzer Zkh, Zwijndrecht - Interne

Zwijndrecht, Netherlands

50BIO.COM Sp. z o.o.

Bydgoszcz, Kujawsko-Pomorskie Voivodeship, Poland

Gierach-Med

Bygdoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Centrum Medyczne Plejady

Krakow, Lesser Poland Voivodeship, Poland

Beata Miklaszewicz & Dariusz Dabrowski "CARDIAMED" s.j.

Legnica, Lower Silesian Voivodeship, Poland

Terpa Sp. z o.o. Sp. k.

Lublin, Lubelskie Voivodeship, Poland

Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego Centrum Medycznego Ksztalcenia Podyplomowego

Warsaw, Masovian Voivodeship, Poland

Instytut Diabetologii Sp. z o.o.

Warsaw, Mazovian Voivodeship, Poland

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Podlaskie Voivodeship, Poland

Gabinet Leczenia Otylosci i Chorob Dietozaleznych

Bialystok, Podlaskie Voivodeship, Poland

NZOZ Vita-Diabetica Malgorzata Buraczyk

Bialystok, Podlaskie Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, Poland

Centrum Medyczne Salvia

Katowice, Slaskie Voivodeship, Poland

Klinika Bellamed

Elblag, Warmian-Masurian Voivodeship, Poland

Centrum Ginekologii, Poloznictwa i Leczenia Nieplodnosci

Poznan, Wielkopolskie Voivodeship, Poland

Centrum Ginekologii, Położnictwa i Leczenia Niepłodności

Poznan, Wielkopolskie Voivodeship, Poland

Centrum Zdrowia Metabolicznego

Poznan, Wielkopolskie Voivodeship, Poland

Centrum Medyczne Plejady

Krakow, Poland

Beata Mikłaszewicz & Dariusz Dąbrowski "CARDIAMED" s.j.

Legnica, Poland

Terpa Sp. z o.o. Sp. k.

Lublin, Poland

Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orłowskiego Centrum Medycznego Kształcenia Podyplomowego

Warsaw, Poland

Instytut Diabetologii Sp. z o.o.

Warsaw, Poland

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

Novi Sad, Vojvodina, Serbia

Endocrinology, Diabetes and Metabolism Diseases Clinic

Belgrade, Serbia

Clinical Hospital Center Bezanijska Kosa

Belgrade, Serbia

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

Novi Sad, Serbia

East Rand Physicians

Benoni, Gauteng, South Africa

Dr R Dulabh

Johannesburg, Gauteng, South Africa

Dr Moosa's Rooms

Lenasia, Gauteng, South Africa

Shop#1 Health Emporium

Midrand, Gauteng, South Africa

Botho ke Bontle Health Services

Pretoria, Gauteng, South Africa

Dr Vawda's site

Durban, KwaZulu-Natal, South Africa

Dr J Reddy

Durban, KwaZulu-Natal, South Africa

Armansis Medical Centre

Brits, North West, South Africa

Dr Hilton Kaplan

Cape Town, Western Cape, South Africa

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

Bucheon-si, Gyeonggi-do, South Korea

The catholic university of Korea, Bucheon St.Mary's Hospital

Bucheon-si, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Daejeon Eulji Medical Center, Eulji University

Daejeon, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Pusan National University Yangsan Hospital

Yangsan, South Korea

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Hospital Clinic i Provincial

Barcelona, Spain

Hospital Vithas Sevilla

Castilleja de la Cuesta, Spain

H. de León_Endocrinología

León, Spain

Hospital de León

León, Spain

Hospital Gregorio Marañón

Madrid, Spain

Clínica Nuevas Tecnologías en Diabetes y Endocrinología

Seville, Spain

H. Infanta Luisa_Endocrino y Obesidad

Seville, Spain

China Medical University Hospital

Taichung, Taiwan

National Taiwan University Hospital_main

Taipei, Taiwan

Baskent University Ankara Hospital

Ankara, Cankaya, Turkey (Türkiye)

Başkent Üniversitesi Ankara Hastanesi-Aile Hekimliği

Ankara, Cankaya, Turkey (Türkiye)

Haseki Egitim ve Arastirma Hastanesi

Sultangazi, Istanbul, Turkey (Türkiye)

Adana Şehir Eğitim ve Araştırma Hastanesi

Adana, Turkey (Türkiye)

Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi

Adana, Turkey (Türkiye)

Ankara Bilkent Şehir Hastanesi-Dahiliye

Ankara, Turkey (Türkiye)

Ankara Sehir Hastanesi Dahiliye Klinigi

Ankara, Turkey (Türkiye)

Akdeniz Üniversitesi Hastanesi- Endokrinoloji

Antalya, Turkey (Türkiye)

Hatay Mustafa Kemal Universitesi Saglik Uygulama ve Arastirm

Hatay, Turkey (Türkiye)

Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji

Istanbul, Turkey (Türkiye)

İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Endokrinoloji

Istanbul, Turkey (Türkiye)

Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi- Endokrinoloji

Istanbul, Turkey (Türkiye)

Haydarpaşa Numune Eğitim ve Araştırma Hastanesi - Endokrinoloji

Istanbul, Turkey (Türkiye)

Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye

Istanbul, Turkey (Türkiye)

Sivas Cumhuriyet Univesity Endocrinology Department

Sivas, Turkey (Türkiye)

Sivas Cumhuriyet Üniversitesi Hastanesi -Endokrinoloji

Sivas, Turkey (Türkiye)

Princess Royal University Hospital

Orpington, Kent, United Kingdom

Layton Medical Centre

Blackpool, United Kingdom

Southmead Hospital

Bristol, United Kingdom

Addenbrooke's Hospital_Cambridge

Cambridge, United Kingdom

Countess of Chester Hospital

Chester, United Kingdom

Hathaway Medical Centre

Chippenham, United Kingdom

University Hospital Coventry - WISDEM Centre

Coventry, United Kingdom

Aintree University Hospital

Liverpool, United Kingdom

University Hospital Aintree

Liverpool, United Kingdom

Guy's Hospital - Diabetes

London, United Kingdom

Imperial College London

London, United Kingdom

University College London - Obesity

London, United Kingdom

Princess Royal University Hospital

Orpington, United Kingdom

Musgrove Park Hospital

Taunton, United Kingdom