A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight

Last updated: March 10, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Not Recruiting

Phase

3

Condition

Obesity

Diabetes Prevention

Treatment

Cagrilintide

Semaglutide

Tirzepatide

Clinical Study ID

NCT06131437
NN9838-7832
U1111-1292-4835
  • Ages > 18
  • All Genders

Study Summary

This study will look at how well CagriSema compared to Tirzepatide helps people lower their body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors. Participant will get injections once a week throughout the treatment period. Participant will inject the study medicine under the skin with a pen injector in the thigh, stomach, or upper arm. After a first low dose, the study medicine will be gradually increased until reaching the planned dose (2.4 mg CagriSema or 15 mg Tirzepatide). The study will last for about one and a half year for each participant.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female

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

  • Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m^2)

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 mellitus

Study Design

Total Participants: 809
Treatment Group(s): 3
Primary Treatment: Cagrilintide
Phase: 3
Study Start date:
November 27, 2023
Estimated Completion Date:
January 13, 2026

Connect with a study center

  • Novo Nordisk Investigational Site

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

  • Univ of Alabama Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Chambliss Clinical Trials LLC

    Montgomery, Alabama 36106
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Montgomery, Alabama 36106
    United States

    Active - Recruiting

  • FDRC

    Costa Mesa, California 92627
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Costa Mesa, California 92627
    United States

    Active - Recruiting

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Univ of Colorado at Denver

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale University School Of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Northeast Research Institute

    Fleming Island, Florida 32003
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Fleming Island, Florida 32003
    United States

    Active - Recruiting

  • Jacksonville Ctr For Clin Res

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Miramar, Florida 33027
    United States

    Active - Recruiting

  • South Broward Research LLC

    Miramar, Florida 33027
    United States

    Site Not Available

  • Hope Clin Res & Wellness

    Conyers, Georgia 30094
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Conyers, Georgia 30094
    United States

    Active - Recruiting

  • East West Med Res Inst

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Honolulu, Hawaii 96814
    United States

    Active - Recruiting

  • Great Lakes Clinical Trials

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chicago, Illinois 60640
    United States

    Active - Recruiting

  • Endeavor Health

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Evanston Premier Hlthcr Res

    Skokie, Illinois 60077
    United States

    Site Not Available

  • NorthShore Univ Hlth Sys

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Midwest Inst For Clin Res

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Indianapolis, Indiana 46260
    United States

    Active - Recruiting

  • Northern Pines Hlth Ctr, PC

    Buckley, Michigan 49620
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Buckley, Michigan 49620
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Saint Peters, Missouri 63303
    United States

    Active - Recruiting

  • StudyMetrix Research LLC

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • Comprehensive Weight Ctrl Prog

    New York, New York 10021
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    New York, New York 10021
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Medication Mgmnt, LLC_Grnsboro

    Greensboro, North Carolina 27405
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greensboro, North Carolina 27405
    United States

    Active - Recruiting

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Accellacare_NC

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Raleigh, North Carolina 27609
    United States

    Active - Recruiting

  • Accellacare

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

  • New Venture Medical Research

    Wadsworth, Ohio 44281
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wadsworth, Ohio 44281
    United States

    Active - Recruiting

  • Lynn Institute of Norman

    Norman, Oklahoma 73072
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Norman, Oklahoma 73072
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19104-3317
    United States

    Active - Recruiting

  • The University of Penn Center

    Philadelphia, Pennsylvania 19104-3317
    United States

    Site Not Available

  • Clinical Res Collaborative

    Cumberland, Rhode Island 02864
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Cumberland, Rhode Island 02864
    United States

    Active - Recruiting

  • Medical University Of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Coastal Carolina Res Ctr

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    North Charleston, South Carolina 29405
    United States

    Active - Recruiting

  • Hillcrest Clinical Research

    Simpsonville, South Carolina 29681-1538
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Simpsonville, South Carolina 29681-1538
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Spartanburg, South Carolina 29303
    United States

    Active - Recruiting

  • Spartanburg Medical Research

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Holston Medical Group_Bristol

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bristol, Tennessee 37620
    United States

    Active - Recruiting

  • Holston Medical Group

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee 37660
    United States

    Active - Recruiting

  • Amarillo Med Spec LLP

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Amarillo, Texas 79106
    United States

    Active - Recruiting

  • Elligo Clin Res Centre

    Austin, Texas 78704
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Austin, Texas 78704
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Bellaire, Texas 77401
    United States

    Site Not Available

  • UT Health University of Texas

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Baylr Sctt White Rs Inst, Endo

    Dallas, Texas 75226
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75226
    United States

    Active - Recruiting

  • UT Southwestern Medical Center-CRU

    Dallas, Texas 75390
    United States

    Site Not Available

  • Velocity Clin Res, Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • DCOL Ctr for Clin Res

    Longview, Texas 75605
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Longview, Texas 75605
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Arlington, Virginia 22206
    United States

    Active - Recruiting

  • Washington Cntr Weight Mgmt

    Arlington, Virginia 22206
    United States

    Site Not Available

  • Health Res of Hampton Roads

    Newport News, Virginia 23606
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Newport News, Virginia 23606
    United States

    Active - Recruiting

  • National Clin Res Inc.

    Richmond, Virginia 23294
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Richmond, Virginia 23294
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Winchester, Virginia 22601
    United States

    Active - Recruiting

  • Selma Medical Associates

    Winchester, Virginia 22601
    United States

    Site Not Available

  • Capital Clin Res Ctr,LLC

    Olympia, Washington 98502
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Olympia, Washington 98502
    United States

    Active - Recruiting

  • Novo Nordisk Investigational Site

    Renton, Washington 98057
    United States

    Active - Recruiting

  • Rainier Clin Res Ctr Inc

    Renton, Washington 98057
    United States

    Site Not Available

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