AzTrials
AzTrials

ObesityPhase 3REDEFINE 1NCT05567796

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

A Phase 3 study testing Cagrilintide and Semaglutide in people with Obesity, run by Novo Nordisk A/S at 256 sites in 23 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Obesity
What is being tested?
Cagrilintide and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,400 participants
Where
256 sitesin 23 countries
Study dates
1 Nov 2022to 19 Oct 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

256 sites in 23 countries.

256 sites in 23 countries

United States46 sites

  • Washington Cntr Weight Mgmt

    Arlington, Virginia, 22206

  • Univ of Colorado at Denver

    Aurora, Colorado, 80045

  • Velocity Clinical Research Binghamton

    Binghamton, New York, 13905

  • Univ of Alabama Birmingham

    Birmingham, Alabama, 35233

  • Holston Medical Group_Bristol

    Bristol, Tennessee, 37620

  • Northern Pines Hlth Ctr, PC

    Buckley, Michigan, 49620

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • University of North Carolina

    Chapel Hill, North Carolina, 27517

  • Medical Uni of SC Charleston

    Charleston, South Carolina, 29425

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • StudyMetrix Research LLC

    City of Saint Peters, Missouri, 63303

  • Hope Clin Res & Wellness

    Conyers, Georgia, 30094

  • Clinical Res Collaborative

    Cumberland, Rhode Island, 02864

  • Baylr Sctt White Rs Inst, Endo

    Dallas, Texas, 75226

  • Velocity Clinical Res-Dallas

    Dallas, Texas, 75230

  • UT Southwestern Med Cntr

    Dallas, Texas, 75390-9302

  • Northeast Research Institute

    Fleming Island, Florida, 32003

  • OptumCare Clinical Trials LLC

    Golden, Colorado, 80401

  • Medication Mgmnt, LLC_Grnsboro

    Greensboro, North Carolina, 27405

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina, 27408

  • East West Med Res Inst

    Honolulu, Hawaii, 96814

  • Midwest Inst For Clin Res

    Indianapolis, Indiana, 46260

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • DCOL Ctr for Clin Res

    Longview, Texas, 75605

  • Velocity Clin Res Los Angeles

    Los Angeles, California, 90017

  • Velocity Clin Res Wstlke

    Los Angeles, California, 90057

  • South Broward Research LLC

    Miramar, Florida, 33027

  • Comprehensive Weight Ctrl Prog

    New York, New York, 10021

  • Health Res of Hampton Roads

    Newport News, Virginia, 23606

  • Lynn Institute of Norman

    Norman, Oklahoma, 73072

  • Coastal Carolina Res Ctr

    North Charleston, South Carolina, 29405

  • Capital Clin Res Ctr,LLC

    Olympia, Washington, 98502

  • Clinical Neuroscience Solution

    Orlando, Florida, 32801

  • Florida Inst For Clin Res

    Orlando, Florida, 32825

  • Florida Institute for Clinical research

    Orlando, Florida, 32825

  • The University of Penn Center

    Philadelphia, Pennsylvania, 19104-3317

  • Clinical Trial Res Assoc,Inc

    Plantation, Florida, 33324

  • Accellacare_NC

    Raleigh, North Carolina, 27609

  • Rainier Clin Res Ctr Inc

    Renton, Washington, 98057

  • Hillcrest Clinical Research

    Simpsonville, South Carolina, 29681-1538

  • Endeavor Health

    Skokie, Illinois, 60077

  • Evanston Premier Hlthcr Res

    Skokie, Illinois, 60077

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • New Venture Medical Research

    Wadsworth, Ohio, 44281

  • Accellacare

    Wilmington, North Carolina, 28401

  • Selma Medical Associates

    Winchester, Virginia, 22601-3834

Other trials in United States

Poland21 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, Podlaskie Voivodeship, 15-276

  • Gabinet Leczenia Otylosci i Chorob Dietozaleznych

    Bialystok, Podlaskie Voivodeship, 15-281

  • NZOZ Vita-Diabetica Malgorzata Buraczyk

    Bialystok, Podlaskie Voivodeship, 15-879

  • 50BIO.COM Sp. z o.o.

    Bydgoszcz, Kujawsko-Pomorskie Voivodeship, 85-107

  • Gierach-Med

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Klinika Bellamed

    Elblag, Warmian-Masurian Voivodeship, 82-300

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-214

  • Centrum Medyczne Salvia

    Katowice, Slaskie Voivodeship, 40-772

  • Centrum Medyczne Plejady

    Krakow, Lesser Poland Voivodeship, 30-363

  • Centrum Medyczne Plejady

    Krakow, 30-363

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

    Legnica, Lower Silesian Voivodeship, 59-220

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

    Legnica, 59-220

  • Terpa Sp. z o.o. Sp. k.

    Lublin, Lubelskie Voivodeship, 20-333

  • Terpa Sp. z o.o. Sp. k.

    Lublin, 20-333

  • Centrum Ginekologii, Poloznictwa i Leczenia Nieplodnosci

    Poznan, Wielkopolskie Voivodeship, 60-198

  • Centrum Ginekologii, Położnictwa i Leczenia Niepłodności

    Poznan, Wielkopolskie Voivodeship, 60-198

  • Centrum Zdrowia Metabolicznego Paweł Bogdański

    Poznan, Wielkopolskie Voivodeship, 60-589

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

    Warsaw, Masovian Voivodeship, 00-416

  • Instytut Diabetologii Sp. z o.o.

    Warsaw, Mazovian Voivodeship, 02-117

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

    Warsaw, 00-416

  • Instytut Diabetologii Sp. z o.o.

    Warsaw, 02-117

Other trials in Poland

India19 sites

  • Belgaum Diabetes Centre

    Belagavi, Karnataka, 590001

  • Post Graduate Institute of Medical Education & Research_Chandigarh

    Chandigarh, Punjab, 160012

  • Maulana Azad Medical College

    Delhi, New Delhi, 110002

  • All India Institute of Medical Sciences_New Dehli

    Delhi, 110029

  • AIG Hospitals,Hyderabad

    Hyderabad, Telangana, 500032

  • Osmania General Hospital

    Hyderabad, 500012

  • SMS Medical College & Hospital

    Jaipur, Rajasthan, 302004

  • Eternal Heart Care Centre

    Jaipur, Rajasthan, 302017

  • Government Medical College, Kozhikode

    Kozhikode, Kerala, 673008

  • Sir H. N. Reliance Foundation Hospital and Research Centre

    Mumbai, Maharashtra, 400004

  • Wockhardt Hospital, Mumbai Central

    Mumbai, Maharashtra, 400011

  • Government Medical College and Super Speciality Hospital, Nagpur

    Nagpur, Maharashtra, 440009

  • Grant Medical Foundation Ruby Hall Clinic

    Pune, Maharashtra, 411001

  • Deenanath Mangeshkar Hospital & Research Centre

    Pune, Maharashtra, 411004

  • Sahyadri Super Speciality Hospital

    Pune, Maharashtra, 411004

  • Chellaram Diabetes Institute

    Pune, Maharashtra, 411021

  • chelleram Diabetes Institute

    Pune, Maharashtra, 411021

  • Nirmal Hospital Pvt. Ltd.

    Surat, Gujarat, 395002

  • Christian Medical College Hospital, Vellore

    Vellore, Tamil Nadu, 632004

Other trials in India

Bulgaria17 sites

  • MHAT Puls AD, Department of Internal Diseases

    Blagoevgrad, 2700

  • Medical centre Asclepius OOD

    Dupnitsa, Kyustendil, 2600

  • OCIPSOMC - Endocrinology NT EOOD

    Montana, 3400

  • OCSOMCE - Dr. Albena Dinkova EOOD

    Pleven, 5800

  • DCC Iztok EOOD

    Plovdiv, 4006

  • ASOMCEM - Individual Practice - Dr. Antoanela Slavcheva

    Rousse, 7002

  • ASOMCEM - IP - Dr. Antoanela Slavcheva

    Rousse, 7002

  • Nader Yabrudi - ASMPVBE Individual practice

    Smolyan, 4700

  • UMHAT Aleksandrovska EAD, Densitometry and Bone Metabolic Diseases

    Sofia, 1431

  • USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology

    Sofia, 1431

  • USHATE Acad. Ivan Penchev EAD, First Clinic of Endocrinology

    Sofia, 1431

  • USHATE Akad. Ivan Penchev EAD, Second Clinic of Endocrinology

    Sofia, 1431

  • DCC XVIII - Sofia EOOD

    Sofia, 1517

  • UMHAT Tsaritsa Yoanna - ISUL EAD, Endocrinology

    Sofia, 1527

  • DCC XX - Sofia EOOD, Endocrinology

    Sofia, 1618

  • AIPSMC Dr. Artin Magardichyan EOOD

    Varna, 9020

  • MC Berbatov EOOD, Cherni Drin

    Yambol, 8600

Other trials in Bulgaria

Turkey (Türkiye)16 sites

  • Adana Şehir Eğitim ve Araştırma Hastanesi

    Adana, 01060

  • Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi

    Adana, 01250

  • Baskent University Ankara Hospital

    Ankara, Cankaya, 06800

  • Başkent Üniversitesi Ankara Hastanesi-Aile Hekimliği

    Ankara, Cankaya, 06800

  • Ankara Bilkent Şehir Hastanesi-Dahiliye

    Ankara, 06800

  • Ankara Sehir Hastanesi Dahiliye Klinigi

    Ankara, 06800

  • Akdeniz Üniversitesi Hastanesi- Endokrinoloji

    Antalya, 07058

  • Hatay Mustafa Kemal Universitesi Saglik Uygulama ve Arastirm

    Hatay, 31060

  • Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji

    Istanbul, 34390

  • İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Endokrinoloji

    Istanbul, 34390

  • Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi- Endokrinoloji

    Istanbul, 34400

  • Haydarpaşa Numune Eğitim ve Araştırma Hastanesi - Endokrinoloji

    Istanbul, 34668

  • Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye

    Istanbul, 34722

  • Sivas Cumhuriyet Univesity Endocrinology Department

    Sivas, 58140

  • Sivas Cumhuriyet Üniversitesi Hastanesi -Endokrinoloji

    Sivas, 58140

  • Haseki Egitim ve Arastirma Hastanesi

    Sultangazi, Istanbul, 34265

Other trials in Turkey (Türkiye)

Japan15 sites

  • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

    Aichi, 468-0009

  • Chiba University Hospital_Diabetes, Metabolism and Endocrinology

    Chiba-shi, Chiba, 260-8677

  • Kawada Clinic

    Gunma, 373-0036

  • Motomachi Takatsuka Naika Clinic_Internal Medicine

    Kanagawa, 231-0023

  • Osaka NISHI-UMEDA Clinic_Internal Medicine

    Osaka, 530-0001

  • Asano Clinic

    Saitama, 350-0851

  • Shinsapporo Seiryou Hospital_General Clinical Department

    Sapporo, Hokkaido, 004-0004

  • Shinden Higashi Clinic_Internal medicine

    Sendai-shi, Miyagi, 983-0039

  • OCROM Clinic_Internal medicine

    Suita-shi, Osaka, 565-0853

  • Tokyo-Eki Center-building Clinic_Internal Medicine

    Tokyo, 103-0027

  • Tokyo-Eki Center-building Clinic

    Tokyo, 103-0027

  • Fukuwa Clinic_Internal Medicine

    Tokyo, 104-0031

  • Miho Clinic

    Tokyo, 141-0032

  • ToCROM Clinic_Internal Medicine

    Tokyo, 160-0008

  • Higashi-shinjuku clinic

    Tokyo, 169-0072

Other trials in Japan

United Kingdom14 sites

  • Layton Medical Centre

    Blackpool, FY3 7EN

  • Southmead Hospital

    Bristol, BS10 5NB

  • Addenbrooke's Hospital_Cambridge

    Cambridge, CB2 0QQ

  • Countess of Chester Hospital

    Chester, CH2 1UL

  • Hathaway Medical Centre

    Chippenham, SN14 6GT

  • University Hospital Coventry - WISDEM Centre

    Coventry, CV2 2DX

  • Aintree University Hospital

    Liverpool, L9 7AL

  • University Hospital Aintree

    Liverpool, L9 7AL

  • Guy's Hospital - Diabetes

    London, SE1 9RT

  • Imperial College London

    London, W12 0HS

  • University College London - Obesity

    London, WC1E 6JF

  • Princess Royal University Hospital

    Orpington, Kent, BR6 8ND

  • Princess Royal University Hospital

    Orpington, BR6 8ND

  • Musgrove Park Hospital

    Taunton, TA1 5DA

Other trials in United Kingdom

South Korea13 sites

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

    Bucheon-si, Gyeonggi-do, 14647

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

    Bucheon-si, Gyeonggi-do, 14647

  • Kyungpook National University Hospital

    Daegu, 14233

  • Daejeon Eulji Medical Center, Eulji University

    Daejeon, 35233

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 50612

  • Pusan National University Yangsan Hospital

    Yangsan, 50612

Other trials in South Korea

Italy11 sites

  • A.O.U. Consorziale Policlinico di Bari

    Bari, BA, 70124

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

    Bologna, 40138

  • ARNAS Garibaldi Catania - Presidio Ospedaliero Garibaldi-Centro

    Catania, 95122

  • Azienda Ospedaliero-Universitaria Renato Dulbecco

    Catanzaro, Cz, 88100

  • Azienda Ospedaliera di Padova Clin.Med.3

    Padova, 35128

  • Ospedale Civico Partinico di Palermo

    Partinico, 90047

  • Pol. Uni. Campus Biomedico

    Roma, RM, 00128

  • Policlinico Universitario Tor Vergata

    Roma, 00133

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

    Roma, 00161

  • Policlinico San Donato S.p.A.

    San Donato Milanese (MI), Lombardy, 20097

  • Azienda Ospedaliera Universitaria Senese

    Siena, SI, 53100

Other trials in Italy

Belgium9 sites

  • Imeldaziekenhuis - Bonheiden - Department of Endocrinology

    Bonheiden, 2820

  • Imelda

    Bonheiden, 2820

  • CHR Mons-Hainaut - Site Warquignies

    Boussu, 7300

  • Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie

    Brussels, 1200

  • UZ Antwerpen - UZA - Department of Endocrinology

    Edegem, 2650

  • UZA - UZ Antwerpen - Department of Endocrinology

    Edegem, 2650

  • UZ Gent - Endocrinologie

    Ghent, 9000

  • UZ Leuven - Endocrinology

    Leuven, 3000

  • CHU Helora - Hôpital de Mons - Site Constantinople

    Mons, 7000

Other trials in Belgium

Germany9 sites

  • Diabetespraxis Mergentheim

    Bad Mergentheim, 97980

  • Zentrum für klinische Studien Südbrandenburg GmbH

    Elsterwerda, 04910

  • InnoDiab Forschung GmbH

    Essen, 45136

  • Wendisch - Dahl Hamburg - DZHW

    Hamburg, 22607

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

    Leipzig, 04103

  • AmBeNet GmbH

    Leipzig, 04107

  • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose

    Münster, 48145

  • MZM Praxis Drs. Erlinger

    Stuttgart, 70378

  • Zentrum für klinische Studien Allgäu Oberschwaben

    Wangen, 88239

Other trials in Germany

South Africa9 sites

  • East Rand Physicians Clinical Research Division (Pty) Ltd

    Benoni, Gauteng, 1501

  • Armansis Medical Centre

    Brits, North West, 0250

  • Dr Hilton Kaplan

    Cape Town, Western Cape, 7708

  • Dr Vawda's site

    Durban, KwaZulu-Natal, 4091

  • Dr J Reddy

    Durban, KwaZulu-Natal, 4450

  • Dr R Dulabh

    Johannesburg, Gauteng, 1812

  • Dr Moosa's Rooms

    Lenasia, Gauteng, 1827

  • Dr A Jacovides and Partners Inc

    Midrand, Gauteng, 1685

  • Botho ke Bontle Health Services

    Pretoria, Gauteng, 0184

Other trials in South Africa

Spain8 sites

  • Hospital Clinic i Provincial

    Barcelona, 08036

  • Hospital Vithas Sevilla

    Castilleja de la Cuesta, 41950

  • H. de León_Endocrinología

    León, 24008

  • Hospital de León

    León, 24008

  • Hospital Gregorio Marañón

    Madrid, 28007

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Clínica Nuevas Tecnologías en Diabetes y Endocrinología

    Seville, 41003

  • H. Infanta Luisa_Endocrino y Obesidad

    Seville, 41010

Other trials in Spain

Canada7 sites

  • C-endo Diab & Endo Clinic

    Edmonton, Alberta, T6H 2L4

  • Nova Scotia Hlth Halifax

    Halifax, Nova Scotia, B3H 1V7

  • Premier Clinical Trial Research Network (PCTRN)

    Hamilton, Ontario, L8M 1K7

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick, E1G 1A7

  • Synergy Wellness Clinic

    Sherwood Park, Alberta, T8H 0N2

  • Ocean West Research Clinic

    Surrey, British Columbia, V3Z 2N6

  • Dr. M.B. Jones Inc

    Victoria, British Columbia, V8V 4A1

Other trials in Canada

Denmark7 sites

  • Aarhus Universitetshospital Diabetes og Hormonsygdomme

    Aarhus N, 8200

  • Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden

    Esbjerg, Region Syddanmark, 6700

  • Center for Klinisk Metabolisk Forskning

    Hellerup, 2900

  • Gentofte Hospital - Center for Klinisk Metabolisk Forskning

    Hellerup, 2900

  • Hvidovre Hospital Endokrinologisk forsknings afsnit 159

    Hvidovre, 2650

  • Sjællands Universitetshospital, Køge - Medicinsk Afdeling

    Køge, Region Sjælland, 4600

  • Sjællands Universitetshospital

    Køge, 4600

Other trials in Denmark

Argentina6 sites

  • CEDIC Centro de Investigación Clínica

    CABA, C1060ABA

  • Centro de Investigación Clínica

    CABA, C1060ABA

  • Centro Médico Viamonte SRL

    CABA, C1120AAC

  • Instituto Centenario

    Ciudad de Buenos Aires, C1204AAD

  • Fundación CESIM

    Santa Rosa, La Pampa Province, 6300

  • Sanatorio Norte

    Santiago del Estero, G4200

Other trials in Argentina

France5 sites

  • APHP - LA PITIE SALPETRIERE _ Service de Nutrition

    Paris, 75013

  • Hospices Civils de Lyon-Hopital Lyon Sud

    Pierre-Bénite, 69310

  • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec

    Saint-Herblain, 44800

  • Les Hopitaux Universitaires de Strasbourg-Hopital de Hautepierre

    Strasbourg, 67098

  • Centre de Recherche Clinique Portes Du Sud

    Vénissieux, 69200

Other trials in France

Mexico5 sites

  • Centro de Investigación Cardiometabólica de Aguascalientes

    Aguascalientes, 20230

  • Consultorio Arechavaleta Granell María del Rosario

    Guadalajara, Jalisco, 44650

  • Centro de Investigacion Clinica Endocrinologica de Jalisco

    Guadalajara, Jalisco, 44670

  • Internal Medicine Clin Trials

    Monterrey, Nuevo León, 64020

  • Cardiolink Clin Trials S.C.

    Monterrey, Nuevo León, 64060

Other trials in Mexico

Netherlands5 sites

  • AmsterdamUMC AMC

    Amsterdam, 1105 AZ

  • Rijnstate Ziekenhuis

    Arnhem, 6815 AD

  • Spaarne Gasthuis Hoofddorp - Interne

    Hoofddorp, 2134 TM

  • Bravis Zkh Roosendaal

    Roosendaal, 4708 AE

  • Albert Schweitzer Zkh, Zwijndrecht - Interne

    Zwijndrecht, 3331 LZ

Other trials in Netherlands

Australia4 sites

  • Northern Beaches Clinical Research

    Brookvale, New South Wales, 2100

  • Novatrials

    Charlestown, New South Wales, 2290

  • Momentum Clinical Research Darlinghurst

    Darlinghurst, New South Wales, 2010

  • Momentum Clinical Research Taringa

    Taringa, Queensland, 4068

Other trials in Australia

Finland4 sites

  • HUS Clinical Research Obesity Unit CRC

    Helsinki, 00290

  • Health Step Finland Oy

    Kuopio, 70600

  • OYS - Sisätautien tutkimusyksikkö

    Oulu, 90220

  • Turku University Hospital

    Turku, 20520

Other trials in Finland

Serbia4 sites

  • Endocrinology, Diabetes and Metabolism Diseases Clinic

    Belgrade, 11000

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11080

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

    Novi Sad, Vojvodina, 21000

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

    Novi Sad, 21000

Other trials in Serbia

Taiwan2 sites

  • China Medical University Hospital

    Taichung, 404

  • National Taiwan University Hospital_main

    Taipei, 100

Other trials in Taiwan

About this study

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

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.

Conditions
Obesity
Being tested
Cagrilintide, Semaglutide, Placebo cagrilintide, Placebo semaglutide
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CagrilintideDrug

    Cagrilintide will be administered subcutaneously.

  • SemaglutideDrug

    Participants will recieve semaglutide subcutaneously.

  • Placebo cagrilintideDrug

    Participants will receive placebo matched to cagrilintide.

  • Placebo semaglutideDrug

    Participants will receive placebo matched to semaglutide.

Study groups in NCT05567796
Study groupRoleWhat they receive
CagrisemaExperimentalParticipants 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.
Receives: Drug: Cagrilintide; Drug: Semaglutide
CagrilintideActive 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.
Receives: Drug: Cagrilintide; Drug: Placebo semaglutide
SemaglutideActive 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.
Receives: Drug: Semaglutide; Drug: Placebo cagrilintide
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.
Receives: Drug: Placebo cagrilintide; Drug: Placebo semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CagriSema versus placebo: Relative change in body weight

    Measured in percentage (%)

    Measured: From baseline (week 0) to end of treatment (week 68)

  2. CagriSema versus placebo: Achievement of greater than or equal to (>=) 5% weight reduction

    Measured as count of participants

    Measured: From baseline (week 0) to end of treatment (week 68)

Secondary outcomes (65)

  1. CagriSema versus placebo: Achievement of >= 20% weight reduction

    Measured as count of participant

    Measured: From baseline (week 0) to end of treatment (week 68)

  2. CagriSema versus placebo: Achievement of >= 25% weight reduction

    Measured as count of participant

    Measured: From baseline (week 0) to end of treatment (week 68)

  3. CagriSema versus placebo: Achievement of >= 30% weight reduction

    Measured as count of participant

    Measured: From baseline (week 0) to end of treatment (week 68)

  4. CagriSema versus cagrilintide and CagriSema versus semaglutide: Relative change in body weight

    Measured as percentage (%)

    Measured: From baseline (week 0) to end of treatment (week 68)

  5. CagriSema versus placebo: Relative change in body weight

    Measured as percentage (%)

    Measured: From baseline (week 0) to week 8

  6. CagriSema versus placebo: Relative change in body weight

    Measured as percentage (%)

    Measured: From baseline (week 0) to week 20

  7. CagriSema versus placebo: Change in waist circumference

    Measured in centimeters (cm)

    Measured: From baseline (week 0) to end of treatment (week 68)

  8. CagriSema versus placebo: Change in systolic blood pressure (SBP)

    Measured in millimeters of mercury (mmHg)

    Measured: From baseline (week 0) to end of treatment (week 68)

  9. CagriSema versus placebo: Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score

    Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.

    Measured: From baseline (week 0) to end of treatment (week 68)

  10. CagriSema versus placebo: Change in SF-v2 Health Survey Acute (SF-36 v2 Acute) Physical Functioning Score

    Measured as score points. The SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being.

    Measured: From baseline (week 0) to end of treatment (week 68)

  11. CagriSema versus placebo, semaglutide and cagrilintide: Change in body weight

    Measured in kilograms (kg)

    Measured: From baseline (week 0) to end of treatment (week 68)

  12. CagriSema versus placebo, semalutide and cagrilintide: Change in body mass index (BMI)

    Measured in kilogram per square meter (kg/m^2)

    Measured: From baseline (week 0) to end of treatment (week 68)

  13. CagriSema versus placebo, semaglutide and cagrilintide: Improvement in weight category

    Measured as count of participants. The categories are: BMI, underweight less than (<) 18.5, normal weight 18.5 to <25, overweight 25.0 to <30, obesity class I 30 to < 35, obesity class II 35 to < 40, obesity class III >40.

    Measured: From baseline (week 0) to end of treatment (week 68)

  14. CagriSema versus placebo: Change in Glycated Haemoglobin (HbA1c)

    Measured as percentage (%)

    Measured: From baseline (week 0) to end of treatment (week 68)

  15. CagriSema versus placebo: Change in HbA1c

    Measured as millimoles per mole (mmol/mol).

    Measured: From baseline (week 0) to end of treatment (week 68)

  16. CagriSema versus placebo: Change in Fasting Plasma Glucose (FPG) (mmol/L).

    Measured as millimoles per liter (mmol/L).

    Measured: From baseline (week 0) to end of treatment (week 68)

  17. CagriSema versus placebo: Change in FPG (mg/dL)

    Measured as milligrams per deciliter (mg/dL).

    Measured: From baseline (week 0) to end of treatment (week 68)

  18. CagriSema versus placebo: Ratio to baseline in fasting serum insulin

    Measured as ratio

    Measured: From baseline (week 0) to end of treatment (week 68)

  19. CagriSema versus placebo: Change in Diastolic Blood Pressure (DBP)

    Measured in mmHg

    Measured: From baseline (week 0) to end of treatment (week 68)

  20. CagriSema versus placebo: Ratio to baseline in total cholesterol

    Measured as ratio

    Measured: From baseline (week 0) to end of treatment (week 68)

  21. CagriSema versus placebo: Ratio to baseline in High-density lipoprotein (HDL) cholesterol

    Measured as ratio

    Measured: From baseline (week 0) to end of treatment (week 68)

  22. CagriSema versus placebo: Ratio to baseline in Low-density lipoprotein (LDL) cholesterol

    Measured as ratio

    Measured: From baseline (week 0) to end of treatment (week 68)

  23. CagriSema versus placebo: Ratio to baseline in Very low-density lipoprotein (VLDL) cholesterol

    Measured as ratio

    Measured: From baseline (week 0) to end of treatment (week 68)

  24. CagriSema versus placebo: Ratio to baseline in Triglycerides

    Measured as ratio

    Measured: From baseline (week 0) to end of treatment (week 68)

  25. CagriSema versus placebo: Ratio to baseline in Free fatty acids

    Measured as ratio

    Measured: From baseline (week 0) to end of treatment (week 68)

  26. CagriSema versus semaglutide and cagrilintide: Change in waist circumference

    Measured in centimeters (cm)

    Measured: From baseline (week 0) to end of treatment (week 68)

  27. CagriSema versus semaglutide and cagrilintide: Change in SBP

    Measured in mmHg

    Measured: From baseline (week 0) to end of treatment (week 68)

  28. CagriSema versus semaglutide and cagrilintide: Ratio to baseline in total cholesterol

    Measured as ratio

    Measured: From baseline (week 0) to end of treatment (week 68)

  29. CagriSema versus semaglutide and cagrilintide: Ratio to baseline in HDL

    Measured as ratio

    Measured: From baseline (week 0) to end of treatment (week 68)

  30. CagriSema versus semaglutide and cagrilintide: Ratio to baseline in LDL

    Measured as ratio

    Measured: From baseline (week 0) to end of treatment (week 68)

  31. CagriSema versus semaglutide and cagrilintide: Ratio to baseline in VLDL

    Measured as ratio

    Measured: From baseline (week 0) to end of treatment (week 68)

  32. CagriSema versus semaglutide and cagrilintide: Ratio to baseline in Triglycerides

    Measured as ratio

    Measured: From baseline (week 0) to end of treatment (week 68)

  33. CagriSema versus semaglutide and cagrilintide: Ratio to baseline in Free fatty acids

    Measured as ratio

    Measured: From baseline (week 0) to end of treatment (week 68)

  34. CagriSema versus placebo: Relative change in body weight (Measured in kilograms (kg))

    Measured in kilograms (kg).

    Measured: From baseline (week 0) to end of treatment (week 68)

  35. CagriSema versus placebo: Relative change in body weight (Measured in percentage (%))

    Measured in percentage (%).

    Measured: From baseline (week 0) to end of treatment (week 68)

  36. CagriSema versus placebo: Absolute change in body weight (Measured in kilograms (kg))

    Measured in kilograms (kg).

    Measured: From baseline (week 0) to end of treatment (week 68)

  37. CagriSema versus placebo: Absolute change in body weight (Measured in percentage (%))

    Measured in percentage (%).

    Measured: From baseline (week 0) to end of treatment (week 68)

  38. CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a absolute to total body mass (Measured as kilograms (kg))

    Measured as kilograms (kg)

    Measured: From baseline (week 0) to end of treatment (week 68)

  39. CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a absolute to total body mass (Measured as percentage (%))

    Measured as percentage (%)

    Measured: From baseline (week 0) to end of treatment (week 68)

  40. CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a relative to total body mass (Measured as kilograms (kg))

    Measured as kilograms (kg)

    Measured: From baseline (week 0) to end of treatment (week 68)

  41. CagriSema versus placebo: Change in total fat mass by Dual energy X-ray absorption (DXA)a relative to total body mass (Measured as percentage (%))

    Measured as percentage (%)

    Measured: From baseline (week 0) to end of treatment (week 68)

  42. CagriSema versus placebo: Change in visceral fat mass by DXA, relative to baseline of fat mass in visceral fat mass region (Measured as percentage (%))

    Measured as percentage (%)

    Measured: From baseline (week 0) to end of treatment (week 68)

  43. CagriSema versus placebo: Change in visceral fat mass by DXA, relative to baseline of fat mass in visceral fat mass region (Measured as %-points)

    Measured as %-points

    Measured: From baseline (week 0) to end of treatment (week 68)

  44. CagriSema versus placebo: Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (Measured as percentage (%))

    Measured as percentage (%).

    Measured: From baseline (week 0) to end of treatment (week 68)

  45. CagriSema versus placebo: Change in visceral fat mass by DXA, relative to total amount of fat mass in visceral fat mass region (Measured as %-points)

    Measured as %-points

    Measured: From baseline (week 0) to end of treatment (week 68)

  46. CagriSema versus placebo: Change in lean body mass by DXA absolute to total body mass (Measured in kilograms (kg))

    Measured in kilograms (kg)

    Measured: From baseline (week 0) to end of treatment (week 68)

  47. CagriSema versus placebo: Change in lean body mass by DXA absolute to total body mass (Measured in percentage (%))

    Measured in percentage (%)

    Measured: From baseline (week 0) to end of treatment (week 68)

  48. CagriSema versus placebo: Change in lean body mass by DXA relative to total body mass (Measured in kilograms (kg))

    Measured in kilograms (kg)

    Measured: From baseline (week 0) to end of treatment (week 68)

  49. CagriSema versus placebo: Change in lean body mass by DXA relative to total body mass (Measured in percentage (%))

    Measured in percentage (%)

    Measured: From baseline (week 0) to end of treatment (week 68)

  50. CagriSema versus placebo: Achievement of at least 14.6- point increase (yes/no) in IWQOL-Lite-CT Physical Function score

    Measured as count of participants. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.

    Measured: From baseline (week 0) to end of treatment (week 68)

  51. CagriSema versus placebo: Achievement of at least 3.7-point increase (yes/no) in SF-36v2 Physical Functioning score

    Measured as count of participants. The SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2. Acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being.

    Measured: From baseline (week 0) to end of treatment (week 68)

  52. CagriSema versus placebo: Change in IWQOL-Lite-CT - Physical Function Score

    Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.

    Measured: From baseline (week 0) to end of treatment (week 68)

  53. CagriSema versus placebo: Change in IWQOL-Lite-CT - Psychosocial Score

    Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.

    Measured: From baseline (week 0) to end of treatment (week 68)

  54. CagriSema versus placebo: Change in IWQOL-Lite-CT - Total Score

    Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.

    Measured: From baseline (week 0) to end of treatment (week 68)

  55. Change in Control of Eating (COEQ): Craving Control Score

    Measured as score points. CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10).

    Measured: From baseline (week 0) to end of treatment (week 68)

  56. Change in COEQ: Craving for Savoury food score

    Measured as score points. CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10).

    Measured: From baseline (week 0) to end of treatment (week 68)

  57. Change in COEQ: Hunger score

    Measured as score points. CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10).

    Measured: From baseline (week 0) to end of treatment (week 68)

  58. Change in COEQ: Craving for Sweets Score

    Measured as score points. CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10).

    Measured: From baseline (week 0) to end of treatment (week 68)

  59. Change in COEQ: Positive Mood score

    Measured as score points. CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10).

    Measured: From baseline (week 0) to end of treatment (week 68)

  60. Change in COEQ: Satiety score

    Measured as score points. CoEQ is a 19-item multidimensional patient-reported outcome (PRO) that assesses the experience of hunger, satiety, and severity and type of food cravings. CoEQ consists of 4 subscales that measure craving control (5 items), positive mood (4 items), craving for sweet (4 items), and craving for savoury food (4 items), and 2 single items that address hunger and satiety. Each item is evaluated on a 0-10 (i.e., 11-point) numeric rating scale. The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale. Scores ranges are thus: Craving Control 0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); single items that address hunger and satiety (0-10).

    Measured: From baseline (week 0) to end of treatment (week 68)

  61. CagriSema versus placebo for subgroup with baseline PGI-S assessment 'Poor' : Change in IWQOL-Lite-CT Physical Function score

    Measured as score points. IWQOL-Lite-CT version 3 is a 20-item COA instrument used to assess the impact of body weight changes in obesity studies on patients' physical and psychosocial functioning in three composite scores (physical function, physical and psychosocial) and a total score.

    Measured: From baseline (week 0) to end of treatment (week 68)

  62. CagriSema versus placebo for subgroup with baseline PGI-S assessment 'Poor' : Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score

    Measured as count of participants.

    Measured: From baseline (week 0) to end of treatment (week 68)

  63. CagriSema versus placebo, semalutide and cagrilintide: Ratio to baseline C-reactive protein (CRP)

    Measured as ratio

    Measured: From baseline (week 0) to end of treatment (week 68)

  64. Number of Treatment Emergent Adverse Events (TEAEs)

    Measured as count of events

    Measured: From baseline (week 0) to end of study-main part (week 75)

  65. Number of Treatment Emergent Serious adverse events (TESAEs)

    Measured as count of events.

    Measured: From baseline (week 0) to end of study-main part (week 75)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2022
  2. Study start1 Nov 2022
  3. Primary completion30 Oct 2024
  4. Study completion19 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05567796
Sponsor's protocol ID
NN9838-4608
Other IDs
Universal Trial Number (UTN), 2020-005435-75
Acronym
REDEFINE 1
Status last verified
Sep 2026
First submitted
3 Oct 2022
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • 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.

    PubMed 41328546

  • Garvey 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.

    PubMed 40544433

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cagrilintide and Semaglutide in people with Obesity, run by Novo Nordisk A/S at 256 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 256 sites in United States, Poland, India, Bulgaria, Turkey (Türkiye) and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CagriSema versus placebo: Relative change in body weight (time frame: From baseline (week 0) to end of treatment (week 68)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05567796, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in