A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
A Placebo-controlled Comparability Study to Compare Two Presentations of CagriSema in Participants With Overweight or Obesity
3 other identifiers
interventional
1,400
14 countries
116
Brief Summary
This study is being done to find out how well a medicine called CagriSema helps people with overweight or obesity lose weight. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. In this study the sponsor will compare two version of CagriSema injected by two different types of injection devices. Which treatment participants get is decided by chance using a computer program, so neither participants nor study staff will know which treatment is given. The study will last for about one year.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2026
116 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2026
CompletedFirst Posted
Study publicly available on registry
January 22, 2026
CompletedStudy Start
First participant enrolled
June 22, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2027
Study Completion
Last participant's last visit for all outcomes
January 17, 2028
February 25, 2026
February 1, 2026
1.4 years
January 21, 2026
February 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Relative change in body weight
Measured in percentage (%).
From baseline (week 0) to end of treatment (week 44)
Secondary Outcomes (2)
Number of TEAEs (treatment emergent adverse events)
From baseline (week 0) to end of study (week 51)
Number of TESAEs (Treatment emergent serious adverse events)
From baseline (week 0) to end of study (week 51)
Study Arms (3)
CagriSema B in device 2 + Placebo in device 1
EXPERIMENTALParticipants will receive CagriSema B in device 2 followed by placebo matched to CagriSema in device 1 subcutaneously once weekly in a dose escalation manner for 16 weeks until the target maintenance dose and further continue to receive the same dose for up to 44 weeks.
CagriSema in device 1 + Placebo in device 2
EXPERIMENTALParticipants will receive CagriSema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly in a dose escalation manner for 16 weeks until the target maintenance dose and further continue to receive the same dose for up to 44 weeks.
Placebo in device 1 + Placebo in device 2
PLACEBO COMPARATORParticipants will receive placebo matched to Cagrisema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly for up to 44 weeks.
Interventions
Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously using device 1 or device 2.
Placebo matched to Cagrilintide and Placebo matched to Semaglutide will be administered subcutaneously using device 1 or device 2.
Eligibility Criteria
You may qualify if:
- Male or female (sex at birth)
- Age 18 years or above at the time of signing the informing consent.
- Body Mass Index (BMI) is greater than or equal to (\>= ) 30.0 kilograms per square metre (kg/m\^2) or BMI \>= 27.0 kg/m\^2 with the presence of at least one obesity-related complication including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
You may not qualify if:
- Glycosylated haemoglobin (HbA1c) \>= 6.5 % (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes.
- Previous exposure to CagriSema in a clinical study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (116)
Uni of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Cahaba Research
Pelham, Alabama, 35124, United States
Advanced Investigative Medicine, Inc.
Hawthorne, California, 90250, United States
Southern Cal Clinical Research
Santa Ana, California, 92701, United States
Encompass Clinical Research_Spring Valley
Spring Valley, California, 91978, United States
Chase Medical Research LLC
Waterbury, Connecticut, 06708, United States
NextPhase Research
Hollywood, Florida, 33024, United States
Oceane 7 Medical & Research Center, Inc.
Miami, Florida, 33144, United States
ForCare Clinical Research
Tampa, Florida, 33613, United States
EBGS Clinical Research Center, LLC
Snellville, Georgia, 30078, United States
Rophe Adult & Pediatric Medicine
Union City, Georgia, 30291, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404, United States
PGM Research of Christie Clinic
Champaign, Illinois, 61822, United States
Arcturus HC PLC Troy Med Res
Troy, Michigan, 48098, United States
Anointed Nephrology & HTN, LLC
Brookhaven, Mississippi, 39601, United States
Palm Research Center Inc.
Las Vegas, Nevada, 89128, United States
Palm Research Center Inc.
Las Vegas, Nevada, 89148, United States
Weill Medical College of Cornell University
New York, New York, 10021, United States
Alliance for Multispecialty Research
Norman, Oklahoma, 73069, United States
Tribe Clinical Research LLC
Greenville, South Carolina, 29607, United States
Walker Family Care
Little River, South Carolina, 29566, United States
Elligo Clin Res Centre
Austin, Texas, 78704, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9302, United States
Forefront Med Res Inst PLLC
Harlingen, Texas, 78550, United States
TPMG Clinical Research
Newport News, Virginia, 23606, United States
Capital Clin Res Ctr,LLC
Olympia, Washington, 98502, United States
IPSMC - Dr. Nikolay Kostadinov EOOD
Burgas, 8000, Bulgaria
Medical Center Viva Feniks OOD
Dobrich, 9300, Bulgaria
IPSOMC Dr. Miglena Rizova Ltd.
Kyustendil, 2500, Bulgaria
UMHAT Pulmed OOD - Plovdiv, Department of Endocrinology
Plovdiv, 4002, Bulgaria
UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Endocrinology
Plovdiv, 4002, Bulgaria
MHAT Sveta Karidad EAD
Plovdiv, 4004, Bulgaria
DCC Iztok EOOD
Plovdiv, 4006, Bulgaria
Medical Centre Razgrad OOD
Razgrad, 7200, Bulgaria
DCC VII - Sofia EOOD, Endocrinology
Sofia, 1233, Bulgaria
Diagnostic-Consultative Anti-Aging and Rejuvenation Center Hill Clinic EAD
Sofia, 1618, Bulgaria
Medical Center Medical Plus EOOD
Varna, 9000, Bulgaria
DCC Mladost - M Varna OOD
Varna, 9009, Bulgaria
AIPSMC Dr. Artin Magardichyan EOOD
Varna, 9020, Bulgaria
Sanos Clinic - Gandrup
Gandrup, 9362, Denmark
Sanos Clinic - Vejle
Vejle, 7100, Denmark
Regionshospitalet Viborg - Karkirurgisk Afsnit
Viborg, 8800, Denmark
251 Air Force General Hospital - Department of Endocrinology & Diabetes
Athens, 11525, Greece
General Hospital Of Athens G Gennimatas - Department of Endocrinology
Athens, 11527, Greece
Laiko General Hospital Of Athens - A' Propaedeutic Clinic of Internal Medicine-Diabetes Centre
Athens, 11527, Greece
Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit
Marousi, 15125, Greece
Athens Medical Center S.A. (Iatriko P. Falirou) - Diabetes and Clinical Research Center
Palaió Fáliro, 17562, Greece
General Hospital Of Thessaloniki G Gennimatas - Internal Medicine Clinic
Thessaloniki, 546 35, Greece
Thermi Clinic S.A. - Diabetes and Internal Medicine Department
Thessaloniki, 57001, Greece
Arina Trial Research Kft.
Orosháza, Bekes County, 5900, Hungary
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
Szeged, Csongrád-Csanád, 6725, Hungary
Belinus Bt.
Debrecen, Hajdú-Bihar, 4025, Hungary
Debreceni Egyetem
Debrecen, Hajdú-Bihar, 4032, Hungary
Borbánya Praxis E.Ü. Kft.
Nyíregyháza, Szabolcs-Szatmar Varmegye, 4405, Hungary
ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
Budapest, 1089, Hungary
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, 15586, Malaysia
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, 56000, Malaysia
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100, Malaysia
Hospital Seri Manjung
Seri Manjung, Perak, 32040, Malaysia
Hospital Pulau Pinang
George Town, Pulau Pinang, 10990, Malaysia
Hospital Miri
Miri, Sarawak, 98000, Malaysia
Klinik Kesihatan Kuang
Rawang, Selangor, 48050, Malaysia
University Technology MARA (UiTM) - Sg Buloh
Sungai Buloh, Selangor, 47000, Malaysia
Klinik Kesihatan Kuala Kedah
Kuala Kedah, 05460, Malaysia
Hospital Melaka
Malacca, 75400, Malaysia
Hospital Queen Elizabeth II
Sabak Bernam, 88300, Malaysia
Gabinet Leczenia Otylosci i Chorob Dietozaleznych
Bialystok, 15-281, Poland
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
Bydgoszcz, 85-231, Poland
Niepubliczny Zakład Opieki Zdrowotnej BIF-MED S.C. Arkadiusz Wawiernia, Mariola Roykiewicz, Rafał Roykiewicz
Bytom, 41-902, Poland
NZOZ Mediart Centrum Zdrowia Matarnia
Gdansk, 80-298, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, 80-382, Poland
ID Clinic Arkadiusz Pisula
Mysłowice, 41-400, Poland
Clinical Best Solutions Sp. z o.o., Sp. k
Warsaw, 00-710, Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, 02-672, Poland
Kardio Life - Tomasz Borkowski
Włocławek, 87-800, Poland
Velocity Nova Sp. z o.o.
Zamość, 22-400, Poland
Prywatna Praktyka Lekarska Anna Chudoba
Żyrardów, 96-300, Poland
ULS De Braga, E.P.E. - Hospital de Braga
Braga, 4710-243, Portugal
ULS Do Alto Ave, E.P.E. - Hospital Senhora da Oliveira - Guimarães
Guimarães, 4835-044, Portugal
Hospital S. Francisco, S.A
Leiria, 2400-110, Portugal
APDP - Associação Protectora dos Diabéticos de Portugal
Lisbon, 1250-189, Portugal
Affidea Montijo - UCardio
Montijo, 2870-100, Portugal
Cardiolima Centro Diagnostico Cardio-Pulmonar De Ponte De Lima Lda
Ponte de Lima, 4990-029, Portugal
Thera Card S.R.L
Brasov, 500102, Romania
Kilostop Junior SRL
Bucharest, 010073, Romania
SC Diamed Obesity SRL
Galati, 800291, Romania
Arcadia Policlinic SRL
Iași, 700620, Romania
Spital Judetean De Urgenta Satu Mare
Satu Mare, 440055, Romania
SC Gensan SRL, Policlinica ASTRA
Sibiu, 550371, Romania
Spitalul Clinic Judetean De Urgenta Targu Mures
Târgu Mureş, 540136, Romania
MED-CENTRUM, s.r.o.
Martin, 036 01, Slovakia
KARDIOMED NZ, s.r.o.
Nové Zámky, 940 01, Slovakia
SVAJDLEROVA, s.r.o.
Prešov, 080 01, Slovakia
ENRIN, s.r.o.
Rimavská Sobota, 979 01, Slovakia
DIAB s.r.o.
Rožňava, 04801, Slovakia
Soweto Clinical Trial Centre
Johannesburg, Gauteng, 1818, South Africa
Ezintsha Research Centre
Johannesburg, Gauteng, 2193, South Africa
Shop#1 Health Emporium
Midrand, Gauteng, 1685, South Africa
Dr Vawda's site
Durban, KwaZulu-Natal, 4091, South Africa
Dr T Padayachee
Durban, KwaZulu-Natal, 4170, South Africa
Clinical Research Institute of South Africa
KwaDukuza, KwaZulu-Natal, 4449, South Africa
Dr Moosa's Rooms
Gauteng, Lenasia, 1827, South Africa
Luzerner Kantonsspital
Lucerne, 6004, Switzerland
Kantonsspital Olten
Olten, 4600, Switzerland
Stoffwechselzentrum St. Gallen
Sankt Gallen, 9016, Switzerland
Diabetes Adipositas Zentrum Zürich
Zollikerberg, 8125, Switzerland
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, 600, Taiwan
Kuang Tien General Hospital
Taichung, 433, Taiwan
Chi Mei Medical Center
Tainan, 710, Taiwan
Taipei Municipal Wan Fang Hospital_Division of Endocrinology & Metabolism
Taipei, 116, Taiwan
Hat Yai hospital
Hat Yai, Changwat Songkhla, 90110, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Maharaj Nakorn Chiang Mai
Chiang Mai, 50200, Thailand
RIHES-CMU_Research Institute for Health Sciences
Chiang Mai, 50200, Thailand
Thammasat Hospital_CRC
Pathum Thani, 12120, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency dept. 2834
Novo Nordisk A/S
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2026
First Posted
January 22, 2026
Study Start (Estimated)
June 22, 2026
Primary Completion (Estimated)
November 29, 2027
Study Completion (Estimated)
January 17, 2028
Last Updated
February 25, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisktrials.com