A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity

Last updated: April 7, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Recruiting

Phase

3

Condition

Obesity

Diabetes Prevention

Treatment

Placebo cagrilintide

Semaglutide

Cagrilintide

Clinical Study ID

NCT06780449
NN9838-7859
2024-512144-39
U1111-1304-7430
  • Ages > 18
  • All Genders

Study Summary

This study will look at how well CagriSema helps people with obesity lose weight compared to a "dummy medicine". CagriSema is a new medicine developed by Novo Nordisk. CagriSema cannot yet be prescribed by doctors. The study has two parts: First part is called the main phase and will last for 2 years, and second part is called the extension phase and will last for 1 year. In the main phase participants will either get CagriSema or "dummy medicine". Which treatment participants get is decided by chance and is not known by participants or the study doctor. In the extension phase participants will get either CagriSema or slowly reduce participants dose of CagriSema if participants had CagriSema in the main phase. Which treatment participants get is decided by chance and is not known by participants or the study doctor in both phases. If participants had "dummy medicine" in the main phase, participants will get CagriSema in the extension phase. Like all medicines, the study medicine may have side effects.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • 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 (>=) 35.0 kilograms per meter square (kg/m^2).

Exclusion

Exclusion criteria:

  • Glycated haemoglobin (HbA1c) >= 6.5 percent (48 millimoles per mole [mmol/mol]) asmeasured by the central laboratory at screening.

  • History of type 1 or type 2 diabetes.

Study Design

Total Participants: 400
Treatment Group(s): 4
Primary Treatment: Placebo cagrilintide
Phase: 3
Study Start date:
February 10, 2025
Estimated Completion Date:
November 17, 2028

Connect with a study center

  • CHU Helora - Site Warquignies

    Boussu, 7300
    Belgium

    Active - Recruiting

  • Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie

    Bruxelles, 1200
    Belgium

    Site Not Available

  • UZA - UZ Antwerpen - Department of Endocrinology

    Edegem, 2650
    Belgium

    Active - Recruiting

  • UZ Leuven - Endocrinology

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Dr. M.B. Jones Inc

    Victoria, British Columbia V8V 4A1
    Canada

    Active - Recruiting

  • Nova Scotia Health Authority

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Active - Recruiting

  • Premier Clinical Trial Research Network (PCTRN)

    Hamilton, Ontario L8L 5G4
    Canada

    Active - Recruiting

  • Alpha Recherche Clinique - Lebourgneuf

    Quebec, G2J 0C4
    Canada

    Active - Recruiting

  • Aarhus Universitetshospital, Steno Diabetes Center Aarhus

    Aarhus, 8200
    Denmark

    Active - Recruiting

  • Sydvestjysk Sygehus Esbjerg

    Esbjerg, 6700
    Denmark

    Active - Recruiting

  • Center for Klinisk Metabolisk Forskning

    Hellerup, 2900
    Denmark

    Active - Recruiting

  • Hvidovre Hospital Endokrinologisk forsknings afsnit 159

    Hvidovre, 2650
    Denmark

    Active - Recruiting

  • Sjællands Universitetshospital

    Køge, 4600
    Denmark

    Active - Recruiting

  • Unidade Local De Saude De Matosinhos E.P.E.

    Senhora Da Hora, Matosinhos, Matosinhos 4464-513
    Portugal

    Active - Recruiting

  • Unidade Local de Saúde de Matosinhos

    Senhora Da Hora, Matosinhos, Matosinhos 4464-513
    Portugal

    Active - Recruiting

  • Unidade Local de Saúde de Matosinhos

    Senhora da Hora, Matosinhos 4464-513
    Portugal

    Site Not Available

  • APDP - Associação Protectora dos Diabéticos de Portugal

    Lisboa, 1250-189
    Portugal

    Active - Recruiting

  • CUF Descobertas

    Lisboa, 1998-018
    Portugal

    Site Not Available

  • Hospital Cuf Descobertas S.A.

    Lisboa, 1998-018
    Portugal

    Active - Recruiting

  • Centro Hospitalar de São João

    Porto, 4200-319
    Portugal

    Site Not Available

  • Unidade Local de Saude de Sao Joao E.P.E

    Porto, 4200-319
    Portugal

    Active - Recruiting

  • Hospital Luz Arrabida, S.A.

    Vila Nova de Gaia, 4400-346
    Portugal

    Active - Recruiting

  • Hospital da Luz Arrabida

    Vila Nova de Gaia, 4400-346
    Portugal

    Site Not Available

  • Southmead Hospital

    Bristol, BS10 5NB
    United Kingdom

    Active - Recruiting

  • Addenbrooke's Hospital_Cambridge

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • WISDEM Centre

    Coventry, CV2 2DX
    United Kingdom

    Active - Recruiting

  • University Hospital Aintree

    Liverpool, L9 7AL
    United Kingdom

    Active - Recruiting

  • Blizard Institute_Royal London Hospital

    London, E1 2AJ
    United Kingdom

    Active - Recruiting

  • Royal London Hospital_London

    London, E1 2AJ
    United Kingdom

    Site Not Available

  • Joint Clinical Research Facility - Swansea

    Swansea, SA2 8PP
    United Kingdom

    Active - Recruiting

  • Musgrove Park Hospital

    Taunton, TA1 5DA
    United Kingdom

    Site Not Available

  • Valley Clinical Trials

    Covina, California 91723
    United States

    Active - Recruiting

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Yale University School Of Medicine

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • East West Medical Research Institute_Honolulu

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • L-MARC Research Center

    Louisville, Kentucky 40213
    United States

    Active - Recruiting

  • StudyMetrix Research LLC

    Saint Peters, Missouri 63303
    United States

    Active - Recruiting

  • Spartanburg Medical Research

    Spartanburg, South Carolina 29303
    United States

    Active - Recruiting

  • Holston Medical Group_Bristol

    Bristol, Tennessee 37620
    United States

    Active - Recruiting

  • North Texas Endocrine Center

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Washington Cntr Weight Mgmt

    Arlington, Virginia 22206
    United States

    Site Not Available

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