A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight

Last updated: April 7, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Not Recruiting

Phase

3

Condition

Diabetes Prevention

Obesity

Treatment

Placebo

Cagrilintide

Semaglutide

Clinical Study ID

NCT06388187
NN9838-7749
2023-509273-24
U1111-1298-3451
  • Ages > 18
  • All Genders

Study Summary

This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female

  • Age above or equal to 18 years at the time of signing informed consent

  1. Body Mass index (BMI) greater than or equal to (≥) 30.0 kilogram per metersquare (kg/m^2) or

  2. BMI ≥27.0 kg/m2 with the presence of at least one obesity related complicationincluding, but not limited to hypertension, dyslipidaemia, obstructive sleepapnoea or cardiovascular disease

Exclusion

Exclusion Criteria:

  • Glycated haemoglobin (HbA1c) ≥6.5% (48 millimoles per mole [mmol/mol]) as measuredby the central laboratory at screening

  • History of type 1 or type 2 diabetes

Study Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
June 24, 2024
Estimated Completion Date:
April 21, 2026

Connect with a study center

  • Ocean West Research Clinic

    Surrey, British Columbia V3Z 2N6
    Canada

    Site Not Available

  • Nova Scotia Health Authority

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • Wharton Med Clin Trials

    Hamilton, Ontario L8L 5G8
    Canada

    Site Not Available

  • Hospices Civils de Lyon-Hopital Lyon Sud-1

    Pierre-Benite, 69310
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1

    Saint Herblain, 44800
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • InnoDiab Forschung GmbH

    Essen, 45136
    Germany

    Site Not Available

  • Wendisch/Dahl Hamburg

    Hamburg, 22607
    Germany

    Site Not Available

  • AmBeNet GmbH

    Leipzig, 04107
    Germany

    Site Not Available

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

    Münster, 48145
    Germany

    Site Not Available

  • Forschungszentrum Ruhr KliFoCenter GmbH, Dr. med. Kahrmann

    Witten, 58455
    Germany

    Site Not Available

  • The Health Centre

    Bradford-on-Avon, BA15 1DQ
    United Kingdom

    Site Not Available

  • Southmead Hospital

    Bristol, BS10 5NB
    United Kingdom

    Site Not Available

  • Addenbrooke's Hospital_Cambridge

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • WISDEM Centre

    Coventry, CV2 2DX
    United Kingdom

    Site Not Available

  • The Staploe Medical Centre

    Soham, CB7 5JD
    United Kingdom

    Site Not Available

  • Joint Clinical Research Facility - Swansea

    Swansea, SA2 8PP
    United Kingdom

    Site Not Available

  • Aurora FDRC Inc.

    Costa Mesa, California 92627
    United States

    Site Not Available

  • Clinical Trial Res Assoc,Inc

    Plantation, Florida 33324
    United States

    Site Not Available

  • Midwest Inst For Clin Res

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Accellacare

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Velocity Clinical Res-Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Washington Cntr Weight Mgmt

    Arlington, Virginia 22206
    United States

    Site Not Available

  • Capital Clin Res Ctr,LLC

    Olympia, Washington 98502
    United States

    Site Not Available

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