A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight

February 24, 2026 updated by: Novo Nordisk A/S

A Placebo-controlled Comparability Study to Compare Two Presentations of CagriSema in Participants With Overweight or Obesity

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8000
        • IPSMC - Dr. Nikolay Kostadinov EOOD
      • Dobrich, Bulgaria, 9300
        • Medical Center Viva Feniks OOD
      • Kyustendil, Bulgaria, 2500
        • IPSOMC Dr. Miglena Rizova Ltd.
      • Plovdiv, Bulgaria, 4006
        • DCC Iztok EOOD
      • Plovdiv, Bulgaria, 4002
        • UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Endocrinology
      • Plovdiv, Bulgaria, 4004
        • MHAT Sveta Karidad EAD
      • Plovdiv, Bulgaria, 4002
        • UMHAT Pulmed OOD - Plovdiv, Department of Endocrinology
      • Razgrad, Bulgaria, 7200
        • Medical Centre Razgrad OOD
      • Sofia, Bulgaria, 1233
        • DCC VII - Sofia EOOD, Endocrinology
      • Sofia, Bulgaria, 1618
        • Diagnostic-Consultative Anti-Aging and Rejuvenation Center Hill Clinic EAD
      • Varna, Bulgaria, 9020
        • AIPSMC Dr. Artin Magardichyan EOOD
      • Varna, Bulgaria, 9000
        • Medical Center Medical Plus EOOD
      • Varna, Bulgaria, 9009
        • DCC Mladost - M Varna OOD
  • Denmark
      • Gandrup, Denmark, 9362
        • Sanos Clinic - Gandrup
      • Vejle, Denmark, 7100
        • Sanos Clinic - Vejle
      • Viborg, Denmark, 8800
        • Regionshospitalet Viborg - Karkirurgisk Afsnit
  • Greece
      • Athens, Greece, 11525
        • 251 Air Force General Hospital - Department of Endocrinology & Diabetes
      • Athens, Greece, 11527
        • General Hospital Of Athens G Gennimatas - Department of Endocrinology
      • Athens, Greece, 11527
        • Laiko General Hospital Of Athens - A' Propaedeutic Clinic of Internal Medicine-Diabetes Centre
      • Marousi, Greece, 15125
        • Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit
      • Palaió Fáliro, Greece, 17562
        • Athens Medical Center S.A. (Iatriko P. Falirou) - Diabetes and Clinical Research Center
      • Thessaloniki, Greece, 546 35
        • General Hospital Of Thessaloniki G Gennimatas - Internal Medicine Clinic
      • Thessaloniki, Greece, 57001
        • Thermi Clinic S.A. - Diabetes and Internal Medicine Department
  • Hungary
      • Budapest, Hungary, 1089
        • ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
    • Bekes County
      • Orosháza, Bekes County, Hungary, 5900
        • Arina Trial Research kft.
    • Csongrád-Csanád
      • Szeged, Csongrád-Csanád, Hungary, 6725
        • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Debreceni Egyetem
      • Debrecen, Hajdú-Bihar, Hungary, 4025
        • Belinus Bt.
    • Szabolcs-Szatmar Varmegye
      • Nyíregyháza, Szabolcs-Szatmar Varmegye, Hungary, 4405
        • Borbánya Praxis E.Ü. Kft.
  • Malaysia
      • Kuala Kedah, Malaysia, 05460
        • Klinik Kesihatan Kuala Kedah
      • Malacca, Malaysia, 75400
        • Hospital Melaka
      • Sabak Bernam, Malaysia, 88300
        • Hospital Queen Elizabeth II
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 15586
        • Hospital Raja Perempuan Zainab II
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Hospital Canselor Tuanku Muhriz UKM
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
    • Perak
      • Seri Manjung, Perak, Malaysia, 32040
        • Hospital Seri Manjung
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10990
        • Hospital Pulau Pinang
    • Sarawak
      • Miri, Sarawak, Malaysia, 98000
        • Hospital Miri
    • Selangor
      • Rawang, Selangor, Malaysia, 48050
        • Klinik Kesihatan Kuang
      • Sungai Buloh, Selangor, Malaysia, 47000
        • University Technology MARA (UiTM) - Sg Buloh
  • Poland
      • Bialystok, Poland, 15-281
        • Gabinet Leczenia Otylosci i Chorob Dietozaleznych
      • Bydgoszcz, Poland, 85-231
        • Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
      • Bytom, Poland, 41-902
        • Niepubliczny Zakład Opieki Zdrowotnej BIF-MED S.C. Arkadiusz Wawiernia, Mariola Roykiewicz, Rafał Roykiewicz
      • Gdansk, Poland, 80-382
        • Synexus Polska Sp. z o.o. Oddzial w Gdansku
      • Gdansk, Poland, 80-298
        • NZOZ Mediart Centrum Zdrowia Matarnia
      • Mysłowice, Poland, 41-400
        • ID Clinic Arkadiusz Pisula
      • Warsaw, Poland, 02-672
        • Synexus Polska Sp. z o.o. Oddzial w Warszawie
      • Warsaw, Poland, 00-710
        • Clinical Best Solutions Sp. z o.o., Sp. k
      • Włocławek, Poland, 87-800
        • Kardio Life - Tomasz Borkowski
      • Zamość, Poland, 22-400
        • Velocity Nova Sp. z o.o.
      • Żyrardów, Poland, 96-300
        • Prywatna Praktyka Lekarska Anna Chudoba
  • Portugal
      • Braga, Portugal, 4710-243
        • ULS De Braga, E.P.E. - Hospital de Braga
      • Guimarães, Portugal, 4835-044
        • ULS Do Alto Ave, E.P.E. - Hospital Senhora da Oliveira - Guimarães
      • Leiria, Portugal, 2400-110
        • Hospital S. Francisco, S.A
      • Lisbon, Portugal, 1250-189
        • APDP - Associação Protectora dos Diabéticos de Portugal
      • Montijo, Portugal, 2870-100
        • Affidea Montijo - UCardio
      • Ponte de Lima, Portugal, 4990-029
        • Cardiolima Centro Diagnostico Cardio-Pulmonar De Ponte De Lima Lda
  • Romania
      • Brasov, Romania, 500102
        • Thera Card S.R.L
      • Bucharest, Romania, 010073
        • Kilostop Junior SRL
      • Galati, Romania, 800291
        • SC Diamed Obesity SRL
      • Iași, Romania, 700620
        • Arcadia Policlinic SRL
      • Satu Mare, Romania, 440055
        • Spital Judetean de Urgenta Satu Mare
      • Sibiu, Romania, 550371
        • SC Gensan SRL, Policlinica ASTRA
      • Târgu Mureş, Romania, 540136
        • Spitalul Clinic Judetean de Urgenta Targu Mures
  • Slovakia
      • Martin, Slovakia, 036 01
        • MED-CENTRUM, s.r.o.
      • Nové Zámky, Slovakia, 940 01
        • KARDIOMED NZ, s.r.o.
      • Prešov, Slovakia, 080 01
        • SVAJDLEROVA, s.r.o.
      • Rimavská Sobota, Slovakia, 979 01
        • ENRIN, s.r.o.
      • Rožňava, Slovakia, 04801
        • DIAB s.r.o.
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1818
        • Soweto Clinical Trial Centre
      • Johannesburg, Gauteng, South Africa, 2193
        • Ezintsha Research Centre
      • Midrand, Gauteng, South Africa, 1685
        • Shop#1 Health Emporium
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4170
        • Dr T Padayachee
      • Durban, KwaZulu-Natal, South Africa, 4091
        • Dr Vawda's site
      • KwaDukuza, KwaZulu-Natal, South Africa, 4449
        • Clinical Research Institute of South Africa
    • Lenasia
      • Gauteng, Lenasia, South Africa, 1827
        • Dr Moosa's Rooms
  • Switzerland
      • Lucerne, Switzerland, 6004
        • Luzerner Kantonsspital
      • Olten, Switzerland, 4600
        • Kantonsspital Olten
      • Sankt Gallen, Switzerland, 9016
        • Stoffwechselzentrum St. Gallen
      • Zollikerberg, Switzerland, 8125
        • Diabetes Adipositas Zentrum Zürich
  • Taiwan
      • Chiayi City, Taiwan, 600
        • Ditmanson Medical Foundation Chia-Yi Christian Hospital
      • Taichung, Taiwan, 433
        • Kuang Tien General Hospital
      • Tainan, Taiwan, 710
        • Chi Mei Medical Center
      • Taipei, Taiwan, 116
        • Taipei Municipal Wan Fang Hospital_Division of Endocrinology & Metabolism
  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital
      • Chiang Mai, Thailand, 50200
        • RIHES-CMU_Research Institute for Health Sciences
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai
      • Pathum Thani, Thailand, 12120
        • Thammasat Hospital_CRC
    • Changwat Songkhla
      • Hat Yai, Changwat Songkhla, Thailand, 90110
        • Hat Yai hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Uni of Alabama at Birmingham
      • Pelham, Alabama, United States, 35124
        • Cahaba Research
    • California
      • Hawthorne, California, United States, 90250
        • Advanced Investigative Medicine, Inc.
      • Santa Ana, California, United States, 92701
        • Southern Cal Clinical Research
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research_Spring Valley
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research LLC
    • Florida
      • Hollywood, Florida, United States, 33024
        • NextPhase Research
      • Miami, Florida, United States, 33144
        • Oceane 7 Medical & Research Center, Inc.
      • Tampa, Florida, United States, 33613
        • Forcare Clinical Research
    • Georgia
      • Snellville, Georgia, United States, 30078
        • EBGS Clinical Research Center, LLC
      • Union City, Georgia, United States, 30291
        • Rophe Adult & Pediatric Medicine
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Diabetes and Osteoporosis Center
    • Illinois
      • Champaign, Illinois, United States, 61822
        • PGM Research of Christie Clinic
    • Michigan
      • Troy, Michigan, United States, 48098
        • Arcturus HC PLC Troy Med Res
    • Mississippi
      • Brookhaven, Mississippi, United States, 39601
        • Anointed Nephrology & HTN, LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center Inc.
      • Las Vegas, Nevada, United States, 89128
        • Palm Research Center Inc.
    • New York
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Alliance for Multispecialty Research
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research LLC
      • Little River, South Carolina, United States, 29566
        • Walker Family Care
    • Texas
      • Austin, Texas, United States, 78704
        • Elligo Clin Res Centre
      • Dallas, Texas, United States, 75390-9302
        • University of Texas Southwestern Medical Center
      • Harlingen, Texas, United States, 78550
        • Forefront Med Res Inst PLLC
    • Virginia
      • Newport News, Virginia, United States, 23606
        • TPMG Clinical Research
    • Washington
      • Olympia, Washington, United States, 98502
        • Capital Clin Res Ctr,LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CagriSema B in device 2 + Placebo in device 1
Participants 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.
Drug: Cagrisema
Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously using device 1 or device 2.
Experimental: CagriSema in device 1 + Placebo in device 2
Participants 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.
Drug: Cagrisema
Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously using device 1 or device 2.
Placebo Comparator: Placebo in device 1 + Placebo in device 2
Participants 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.
Drug: Placebo CagriSema
Placebo matched to Cagrilintide and Placebo matched to Semaglutide will be administered subcutaneously using device 1 or device 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative change in body weight
Time Frame: From baseline (week 0) to end of treatment (week 44)
Measured in percentage (%).
From baseline (week 0) to end of treatment (week 44)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of TEAEs (treatment emergent adverse events)
Time Frame: From baseline (week 0) to end of study (week 51)
Measured in count of events.
From baseline (week 0) to end of study (week 51)
Number of TESAEs (Treatment emergent serious adverse events)
Time Frame: From baseline (week 0) to end of study (week 51)
Measured in count of events.
From baseline (week 0) to end of study (week 51)

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 22, 2026

Primary Completion (Estimated)

November 29, 2027

Study Completion (Estimated)

January 17, 2028

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9838-8166
  • U1111-1317-0133 (Other Identifier: World Health Organization)
  • 2024-520448-41 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisktrials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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