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: August 28, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Not Recruiting

Phase

3

Condition

Obesity

Diabetes Prevention

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

    Site Not Available

  • Linda Vista Health Care Ctr

    San Diego, California 92111
    United States

    Site Not Available

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • FDRC

    Costa Mesa 5339840, California 5332921 92627
    United States

    Site Not Available

  • Linda Vista Health Care Ctr

    San Diego 5391811, California 5332921 92111
    United States

    Site Not Available

  • Diablo Clinical Research, Inc.

    Walnut Creek 5406990, California 5332921 94598
    United States

    Site Not Available

  • Northeast Research Institute

    Fleming Island, Florida 32003
    United States

    Site Not Available

  • Jacksonville Ctr For Clin Res

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • South Broward Research LLC

    Miramar, Florida 33027
    United States

    Site Not Available

  • Florida Inst For Clin Res LLC

    Orlando, Florida 32825
    United States

    Site Not Available

  • Oviedo Medical Research, LLC

    Oviedo, Florida 32765
    United States

    Site Not Available

  • Cnt for Diab,Obes, and Metab

    Pembroke Pines, Florida 33024
    United States

    Site Not Available

  • Northeast Research Institute

    Fleming Island 4155594, Florida 4155751 32003
    United States

    Site Not Available

  • Jacksonville Ctr For Clin Res

    Jacksonville 4160021, Florida 4155751 32216
    United States

    Site Not Available

  • South Broward Research LLC

    Miramar 4164601, Florida 4155751 33027
    United States

    Site Not Available

  • Florida Inst For Clin Res LLC

    Orlando 4167147, Florida 4155751 32825
    United States

    Site Not Available

  • Oviedo Medical Research, LLC

    Oviedo 4167348, Florida 4155751 32765
    United States

    Site Not Available

  • Cnt for Diab,Obes, and Metab

    Pembroke Pines 4168139, Florida 4155751 33024
    United States

    Site Not Available

  • Hope Clin Res & Wellness

    Conyers, Georgia 30094
    United States

    Site Not Available

  • Endocrine Research Solutions

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Hope Clin Res & Wellness

    Conyers 4189213, Georgia 4197000 30094
    United States

    Site Not Available

  • Endocrine Research Solutions

    Roswell 4219934, Georgia 4197000 30076
    United States

    Site Not Available

  • Great Lakes Clinical Trials

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Endeavor Health

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Evanston Premier Hlthcr Res

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Great Lakes Clinical Trials

    Chicago 4887398, Illinois 4896861 60640
    United States

    Site Not Available

  • Endeavor Health

    Skokie 4911600, Illinois 4896861 60077
    United States

    Site Not Available

  • Evanston Premier Hlthcr Res

    Skokie 4911600, Illinois 4896861 60077
    United States

    Site Not Available

  • Midwest Inst For Clin Res

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Midwest Inst For Clin Res

    Indianapolis 4259418, Indiana 4921868 46260
    United States

    Site Not Available

  • Iowa Diab & Endo Res Center

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Iowa Diab & Endo Res Center

    West Des Moines 4881346, Iowa 4862182 50266
    United States

    Site Not Available

  • Northern Pines Hlth Ctr, PC

    Buckley, Michigan 49620
    United States

    Site Not Available

  • Northern Pines Hlth Ctr, PC

    Buckley 4987287, Michigan 5001836 49620
    United States

    Site Not Available

  • Amicis Centers of Clinical Research

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • StudyMetrix Research LLC

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • StudyMetrix Research LLC

    City of Saint Peters 4407237, Missouri 4398678 63303
    United States

    Site Not Available

  • Amicis Centers of Clinical Research

    St Louis 4407066, Missouri 4398678 63128
    United States

    Site Not Available

  • Mercury Str Med Grp, PLLC

    Butte, Montana 59701
    United States

    Site Not Available

  • Mercury Str Med Grp, PLLC

    Butte 5642934, Montana 5667009 59701
    United States

    Site Not Available

  • Southgate Medical Group, LLP

    West Seneca, New York 14224
    United States

    Site Not Available

  • Great Lakes Medical Research

    Westfield, New York 14787
    United States

    Site Not Available

  • Southgate Medical Group, LLP

    West Seneca 5143992, New York 5128638 14224
    United States

    Site Not Available

  • Great Lakes Medical Research

    Westfield 5144083, New York 5128638 14787
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • 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

    Site Not Available

  • Piedmont Healthcare/Research

    Statesville, North Carolina 28625
    United States

    Site Not Available

  • Accellacare

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

    Site Not Available

  • Medication Mgmnt, LLC_Grnsboro

    Greensboro 4469146, North Carolina 4482348 27405
    United States

    Site Not Available

  • PharmQuest Life Sciences LLC

    Greensboro 4469146, North Carolina 4482348 27408
    United States

    Site Not Available

  • Accellacare_NC

    Raleigh 4487042, North Carolina 4482348 27609
    United States

    Site Not Available

  • Piedmont Healthcare/Research

    Statesville 4493316, North Carolina 4482348 28625
    United States

    Site Not Available

  • Accellacare

    Wilmington 4499379, North Carolina 4482348 28401
    United States

    Site Not Available

  • New Venture Medical Research

    Wadsworth, Ohio 44281-9236
    United States

    Site Not Available

  • New Venture Medical Research

    Wadsworth 5175496, Ohio 5165418 44281-9236
    United States

    Site Not Available

  • Lynn Institute of Norman

    Norman, Oklahoma 73072
    United States

    Site Not Available

  • Lynn Institute of Norman

    Norman 4543762, Oklahoma 4544379 73072
    United States

    Site Not Available

  • Clinical Res Collaborative

    Cumberland, Rhode Island 02864
    United States

    Site Not Available

  • Clinical Res Collaborative

    Cumberland 5221703, Rhode Island 5224323 02864
    United States

    Site Not Available

  • Coastal Carolina Res Ctr

    North Charleston, South Carolina 29405
    United States

    Site Not Available

  • Hillcrest Clinical Research

    Simpsonville, South Carolina 29681-1538
    United States

    Site Not Available

  • Spartanburg Medical Research

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Coastal Carolina Res Ctr

    North Charleston 4589387, South Carolina 4597040 29405
    United States

    Site Not Available

  • Hillcrest Clinical Research

    Simpsonville 4595864, South Carolina 4597040 29681-1538
    United States

    Site Not Available

  • Spartanburg Medical Research

    Spartanburg 4597200, South Carolina 4597040 29303
    United States

    Site Not Available

  • Holston Medical Group

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Clinical Research Associates

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Holston Medical Group

    Kingsport 4634662, Tennessee 4662168 37660
    United States

    Site Not Available

  • Clinical Research Associates

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • Amarillo Med Spec LLP

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Velocity Clin Res, Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • PlanIt Research, PLLC

    Houston, Texas 77079
    United States

    Site Not Available

  • Radiance Clinical Research

    Lampasas, Texas 76550
    United States

    Site Not Available

  • DCOL Ctr for Clin Res

    Longview, Texas 75605
    United States

    Site Not Available

  • Northeast Clinical Research of San Antonio

    Schertz, Texas 78154
    United States

    Site Not Available

  • Amarillo Med Spec LLP

    Amarillo 5516233, Texas 4736286 79106
    United States

    Site Not Available

  • Velocity Clin Res, Dallas

    Dallas 4684888, Texas 4736286 75230
    United States

    Site Not Available

  • PlanIt Research, PLLC

    Houston 4699066, Texas 4736286 77079
    United States

    Site Not Available

  • Radiance Clinical Research

    Lampasas 4705176, Texas 4736286 76550
    United States

    Site Not Available

  • Northeast Clinical Research of San Antonio

    Schertz 4727326, Texas 4736286 78154
    United States

    Site Not Available

  • 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

  • Selma Medical Associates

    Winchester, Virginia 22601-3834
    United States

    Site Not Available

  • Washington Cntr Weight Mgmt

    Arlington 4744709, Virginia 6254928 22206
    United States

    Site Not Available

  • Health Res of Hampton Roads

    Newport News 4776024, Virginia 6254928 23606
    United States

    Site Not Available

  • Selma Medical Associates

    Winchester 4794120, Virginia 6254928 22601-3834
    United States

    Site Not Available

  • Rainier Clin Res Ctr Inc

    Renton, Washington 98057
    United States

    Site Not Available

  • Rainier Clin Res Ctr Inc

    Renton 5808189, Washington 5815135 98057
    United States

    Site Not Available

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