A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term

Last updated: June 10, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Prevention

Obesity

Treatment

CagriSema (Cagrilintide B and Semaglutide I)

Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

Clinical Study ID

NCT07011667
NN9838-8484
U1111-1318-6372
  • Ages > 18
  • All Genders

Study Summary

This study will look at how well CagriSema helps people living with obesity to lose weight and maintain the weight loss long-term. The study has 2 parts: The first part is called 'the main study' and the second part is called 'the extension study'. In the main study participants will either get CagriSema (a study medicine) or placebo (a dummy medicine that looks like CagriSema but has no active ingredient). Which treatment participants get is decided by chance. Participants are two times more likely to get CagriSema than placebo. If participants get CagriSema in the main study, participants will continue on CagriSema in the extension study. Which dose of CagriSema participants will continue on is decided by chance. If participants get placebo in the main study, participants will get CagriSema in the extension study. Participants will take one injection of study medicine once a week. The study will last for about 3 years and 3 months.

Eligibility Criteria

Inclusion

key Inclusion Criteria:

  • Male or female (sex at birth).

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

  • BMI ≥ 30.0 kilogram per square meter (kg/m^2) at screening.

  • Participant has a wish to lose at least 25% of body weight within 80 weeks fromrandomisation.

Exclusion

key Exclusion Criteria:

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

  • History of type 1 or type 2 diabetes.

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: CagriSema (Cagrilintide B and Semaglutide I)
Phase: 3
Study Start date:
June 03, 2025
Estimated Completion Date:
November 01, 2028

Connect with a study center

  • FDRC

    Costa Mesa, California 92627
    United States

    Active - Recruiting

  • Linda Vista Health Care Ctr

    San Diego, California 92111
    United States

    Active - Recruiting

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Northeast Research Institute

    Fleming Island, Florida 32003
    United States

    Active - Recruiting

  • Jacksonville Ctr For Clin Res

    Jacksonville, Florida 32216
    United States

    Active - Recruiting

  • South Broward Research LLC

    Miramar, Florida 33027
    United States

    Active - Recruiting

  • Florida Inst For Clin Res LLC

    Orlando, Florida 32825
    United States

    Active - Recruiting

  • Oviedo Medical Research, LLC

    Oviedo, Florida 32765
    United States

    Active - Recruiting

  • Cnt for Diab,Obes, and Metab

    Pembroke Pines, Florida 33024
    United States

    Active - Recruiting

  • Hope Clin Res & Wellness

    Conyers, Georgia 30094
    United States

    Active - Recruiting

  • Endocrine Research Solutions

    Roswell, Georgia 30076
    United States

    Active - Recruiting

  • Great Lakes Clinical Trials

    Chicago, Illinois 60640
    United States

    Active - Recruiting

  • Endeavor Health

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Evanston Premier Hlthcr Res

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Midwest Inst For Clin Res

    Indianapolis, Indiana 46260
    United States

    Active - Recruiting

  • Iowa Diab & Endo Res Center

    West Des Moines, Iowa 50266
    United States

    Active - Recruiting

  • Northern Pines Hlth Ctr, PC

    Buckley, Michigan 49620
    United States

    Active - Recruiting

  • Amicis Centers of Clinical Research

    Saint Louis, Missouri 63128
    United States

    Active - Recruiting

  • StudyMetrix Research LLC

    Saint Peters, Missouri 63303
    United States

    Active - Recruiting

  • Mercury Str Med Grp, PLLC

    Butte, Montana 59701
    United States

    Active - Recruiting

  • Southgate Medical Group, LLP

    West Seneca, New York 14224
    United States

    Active - Recruiting

  • Great Lakes Medical Research

    Westfield, New York 14787
    United States

    Active - Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • Medication Mgmnt, LLC_Grnsboro

    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

    Active - Recruiting

  • Piedmont Healthcare/Research

    Statesville, North Carolina 28625
    United States

    Active - Recruiting

  • Accellacare

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

  • New Venture Medical Research

    Wadsworth, Ohio 44281-9236
    United States

    Active - Recruiting

  • Lynn Institute of Norman

    Norman, Oklahoma 73072
    United States

    Active - Recruiting

  • Clinical Res Collaborative

    Cumberland, Rhode Island 02864
    United States

    Active - Recruiting

  • Coastal Carolina Res Ctr

    North Charleston, South Carolina 29405
    United States

    Active - Recruiting

  • Hillcrest Clinical Research

    Simpsonville, South Carolina 29681-1538
    United States

    Active - Recruiting

  • Spartanburg Medical Research

    Spartanburg, South Carolina 29303
    United States

    Active - Recruiting

  • Holston Medical Group

    Kingsport, Tennessee 37660
    United States

    Active - Recruiting

  • Clinical Research Associates

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Amarillo Med Spec LLP

    Amarillo, Texas 79106
    United States

    Active - Recruiting

  • Velocity Clin Res, Dallas

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • PlanIt Research, PLLC

    Houston, Texas 77079
    United States

    Active - Recruiting

  • Radiance Clinical Research

    Lampasas, Texas 76550
    United States

    Active - Recruiting

  • DCOL Ctr for Clin Res

    Longview, Texas 75605
    United States

    Site Not Available

  • Northeast Clinical Research of San Antonio

    Schertz, Texas 78154
    United States

    Active - Recruiting

  • Washington Cntr Weight Mgmt

    Arlington, Virginia 22206
    United States

    Active - Recruiting

  • Health Res of Hampton Roads

    Newport News, Virginia 23606
    United States

    Active - Recruiting

  • Selma Medical Associates

    Winchester, Virginia 22601-3834
    United States

    Active - Recruiting

  • Rainier Clin Res Ctr Inc

    Renton, Washington 98057
    United States

    Active - Recruiting

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