Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide

Last updated: April 20, 2026
Sponsor: Novo Nordisk A/S
Overall Status: Active - Not Recruiting

Phase

3

Condition

Diabetes And Hypertension

Diabetes Prevention

Diabetes Mellitus, Type 2

Treatment

Placebo (matched to Cagrilintide)

Cagrilintide

Clinical Study ID

NCT07220759
NN9833-8243
2024-519531-41
U1111-1314-9328
  • Ages > 18
  • All Genders

Study Summary

This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participant will either get cagrilintide or placebo. Which treatment participant get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. For each participant, the study will last for about 1 year and 6 months.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Informed consent obtained before any study-related activities. Study-relatedactivities are any procedures that are carried out as part of the study, includingactivities to determine suitability for the study.

  • Female or male (sex at birth).

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

  • History of at least one self-reported unsuccessful dietary effort to lose bodyweight.(a*)

  • Body mass index (BMI) >= 27.0 kilogram per square meter (kg/m^2).(a*)

  • Diagnosed with type 2 diabetes >= 180 days before screening.

  • Treatment with either lifestyle intervention(a*), or:

  • Stable treatment (same drug(s), dose and dosing frequency) for at least 90 daysbefore screening with 1-3 marketed oral antidiabetic drugs (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2inhibitor (SGLT2i), thiazolidinediones, Dipeptidyl peptidase-4 inhibitor (DPP-4i) or sulphonylureas (SU) as a single agent or in combination accordingto local practice.(a*)

  • For up to 30% of participants the following concomitant medication is allowed:

  • Treatment for any indication with a stable dose of glucagon-like peptide-1 (GLP-1) containing medication, stable for at least 1 year before screening (a*) and/or

  • Treatment with basal insulin minimum (0.25 units per kilogram per day (U/kg/day) or 20 units per day [U/day]) stable for at least 90 days beforescreening.(a*)

Exclusion

Key Exclusion Criteria:

  • Treatment, or intention to initiate treatment, with any medication prescribed forthe indication of weight management within 180 days before screening.(a*)

  • Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or GLP-1containing medication within 180 days before screening, apart from those randomizedaccording to inclusion criteria 7bi.(a*)

  • Previous dosing of marketed or non-marketed amylin-based compounds.(a*) (a*) - Asdeclared by the participant, reported in the medical records or at theinvestigator's discretion.

Study Design

Total Participants: 330
Treatment Group(s): 2
Primary Treatment: Placebo (matched to Cagrilintide)
Phase: 3
Study Start date:
November 05, 2025
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Buenos Aires Mácula

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1061AAE
    Argentina

    Site Not Available

  • CICEMO- Consultorio de Investigación Clínica EMO

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1405BUB
    Argentina

    Site Not Available

  • Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

    Buenos Aires, C1425AGC
    Argentina

    Site Not Available

  • Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

    Buenos Aires 3435910, C1425AGC
    Argentina

    Site Not Available

  • OCT Research ULC (dba Okanagan Clinical Trials)

    Kelowna, British Columbia V1Y 1Z9
    Canada

    Site Not Available

  • OCT Research ULC (dba Okanagan Clinical Trials)

    Kelowna 5990579, British Columbia 5909050 V1Y 1Z9
    Canada

    Site Not Available

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick E1G 1A7
    Canada

    Site Not Available

  • G.A. Research Associates Ltd.

    Moncton 6076211, New Brunswick 6087430 E1G 1A7
    Canada

    Site Not Available

  • Nova Scotia Hlth Halifax

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • Nova Scotia Hlth Halifax

    Halifax 6324729, Nova Scotia 6091530 B3H 1V7
    Canada

    Site Not Available

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario L6S 0C6
    Canada

    Site Not Available

  • Hamilton Medical Rsrch Grp

    Hamilton, Ontario L8L 5G4
    Canada

    Site Not Available

  • Wharton Med Clin Trials

    Hamilton, Ontario L8L 5G8
    Canada

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  • Wharton Medical Clinic Clinical Trials (Hamilton)

    Hamilton, Ontario L8L 5G8
    Canada

    Site Not Available

  • Milestone Research

    London, Ontario N5W 6A2
    Canada

    Site Not Available

  • Centricity Research Brampton

    Brampton 5907364, Ontario 6093943 L6S 0C6
    Canada

    Active - Recruiting

  • Centricity Research Brampton Endocrinology

    Brampton 5907364, Ontario 6093943 L6S 0C6
    Canada

    Site Not Available

  • Hamilton Medical Rsrch Grp

    Hamilton 5969782, Ontario 6093943 L8L 5G4
    Canada

    Site Not Available

  • Wharton Med Clin Trials

    Hamilton 5969782, Ontario 6093943 L8L 5G8
    Canada

    Active - Recruiting

  • Milestone Research

    London 6058560, Ontario 6093943 N5W 6A2
    Canada

    Site Not Available

  • Centricity Res Pointe-Claire

    Pointe-Claire, Quebec H9R 4S3
    Canada

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  • Diex Recherche Victoriaville

    Victoriaville, Quebec G6P 3Z8
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  • Centricity Res Pointe-Claire

    Pointe-Claire 6107325, Quebec 6115047 H9R 4S3
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  • Diex Recherche Victoriaville

    Victoriaville 6174151, Quebec 6115047 G6P 3Z8
    Canada

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  • Opca bolnica Karlovac

    Karlovac, 47000
    Croatia

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    Karlovac 3345300, 47000
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  • Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology

    Krapinske Toplice, 49217
    Croatia

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  • Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice

    Krapinske Toplice 3197364, 49217
    Croatia

    Active - Recruiting

  • Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology

    Krapinske Toplice 3197364, 49217
    Croatia

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  • Poliklinika SLAVONIJA OSIJEK

    Osijek, 31000
    Croatia

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    Osijek 3193935, 31000
    Croatia

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    Zagreb, 10000
    Croatia

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    Zagreb 3186886, 10000
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    Prague, 150 00
    Czechia

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    Prague, 149 00
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    Prague 3067696, 150 00
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    Prague 3067696, 149 00
    Czechia

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    České Budějovice, 370 11
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    Debrecen, Hajdú-Bihar 4032
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  • Debreceni Egyetem

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    Budapest, Pest County 1036
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    Komárom, 2900
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    Komárom 3049519, 2900
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    Ploieşti, Prahova 100179
    Romania

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    Ploieşti 670474, Prahova 669737 100179
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    Bacau, 600154
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    Bacau 685948, 600154
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    Bucharest, 050913
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    Bucharest 683506, 050913
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    Galati, 800001
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    Galati 677697, 800001
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    Satu Mare, 440055
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    Satu Mare 667873, 440055
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  • Nemocnica akademika L. Derera, UNB

    Bratislava, 831 01
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  • Nemocnica akademika L. Derera, UNB

    Bratislava 3060972, 831 01
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    Rožňava 723713, 04801
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  • IRIDIA s.r.o.

    Vrútky, 038 61
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    Vrútky 3056683, 038 61
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  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do 50612
    South Korea

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  • Pusan National University Yangsan Hospital

    Yangsan 1832828, Gyeongsangnam-do 1902028 50612
    South Korea

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  • Chonnam National University Hospital

    Gwangju, 61469
    South Korea

    Site Not Available

  • Chonnam National University Hospital

    Gwangju 1841811, 61469
    South Korea

    Site Not Available

  • Kyunghee University Medical Center

    Seoul, 130-872
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    South Korea

    Site Not Available

  • The Catholic University of Korea, Seoul ST. Mary's Hospital

    Seoul, 06591
    South Korea

    Site Not Available

  • The Catholic University of Korea, Yeouido ST. Mary's Hospital

    Seoul, 07345
    South Korea

    Site Not Available

  • Kyunghee University Medical Center

    Seoul 1835848, 130-872
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Active - Recruiting

  • The Catholic University of Korea, Seoul ST. Mary's Hospital

    Seoul 1835848, 06591
    South Korea

    Active - Recruiting

  • The Catholic University of Korea, Yeouido ST. Mary's Hospital

    Seoul 1835848, 07345
    South Korea

    Site Not Available

  • The Catholic University of Korea, Yeouido ST. Mary's Hospital.

    Seoul 1835848, 07345
    South Korea

    Active - Recruiting

  • Universitätsspital Basel

    Basel, 4031
    Switzerland

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  • Universitätsspital Basel

    Basel 2661604, 4031
    Switzerland

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  • Centre hospitalier universitaire vaudois CHUV

    Lausanne, 1011
    Switzerland

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  • Centre hospitalier universitaire vaudois CHUV

    Lausanne 2659994, 1011
    Switzerland

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  • Kantonsspital Olten

    Olten, 4600
    Switzerland

    Site Not Available

  • Kantonsspital Olten

    Olten 2659297, 4600
    Switzerland

    Site Not Available

  • Diabetes Adipositas Zentrum Zürich

    Zollikerberg, 8125
    Switzerland

    Site Not Available

  • Diabetes Adipositas Zentrum Zürich

    Zollikerberg 6293731, 8125
    Switzerland

    Site Not Available

  • Oak Tree Surgery

    Liskeard, Cornwall PL14 3XA
    United Kingdom

    Site Not Available

  • Oak Tree Surgery

    Liskeard 2644409, Cornwall PL14 3XA
    United Kingdom

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  • North Coast Medical Ltd

    Newquay, Cornwall TR7 1RU
    United Kingdom

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    Newquay 2641589, Cornwall TR7 1RU
    United Kingdom

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  • Brunel Medical Practice

    Torquay, Devon TQ1 4QX
    United Kingdom

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  • Brunel Medical Practice

    Torquay 2635650, Devon TQ1 4QX
    United Kingdom

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  • Attenborough Surgery

    Bushey, Hertfordshire WD23 2NN
    United Kingdom

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  • Attenborough Surgery

    Bushey 2654179, Hertfordshire WD23 2NN
    United Kingdom

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  • Hammersmith and Fulham Partnership Research Unit - Richford Gate Primary Care Centre

    London, W6 7HY
    United Kingdom

    Site Not Available

  • Hammersmith and Fulham Partnership Research Unit - Richford Gate Primary Care Centre

    London 2643743, W6 7HY
    United Kingdom

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  • Univ of Alabama_Birmingham

    Birmingham, Alabama 35294
    United States

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  • Chambliss Clinical Trials, LLC

    Montgomery, Alabama 36106
    United States

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  • Univ of Alabama_Birmingham

    Birmingham 4049979, Alabama 4829764 35294
    United States

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  • Chambliss Clinical Trials, LLC

    Montgomery 4076784, Alabama 4829764 36106
    United States

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  • Elite Clinical Network - Tucson

    Tucson, Arizona 85704
    United States

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  • Elite Clinical Network - Tucson

    Tucson 5318313, Arizona 5551752 85704
    United States

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  • Scripps Whittier Diabetes Inst

    La Jolla, California 92037
    United States

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  • Clinical Trials Research

    Lincoln, California 95648
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  • Pacific Clinical Studies

    Los Alamitos, California 90720
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  • Scripps Whittier Diabetes Inst

    La Jolla 5363943, California 5332921 92037
    United States

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  • Clinical Trials Research

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    Los Alamitos 5368304, California 5332921 90720
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  • Walgreens - Store 4442

    Kissimmee, Florida 34746
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  • Optimal Research Sites

    Orange City, Florida 32763
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  • Center for Diab,Obes & Metab

    Pembroke Pines, Florida 33024
    United States

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  • Palm Beach Research Center

    West Palm Beach, Florida 33409
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  • Walgreens - Store 4442

    Kissimmee 4160983, Florida 4155751 34746
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  • Optimal Research Sites

    Orange City 4167055, Florida 4155751 32763
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  • Center for Diab,Obes & Metab

    Pembroke Pines 4168139, Florida 4155751 33024
    United States

    Site Not Available

  • Cnt for Diab,Obes, and Metab

    Pembroke Pines 4168139, Florida 4155751 33024
    United States

    Active - Recruiting

  • Palm Beach Research Center

    West Palm Beach 4177887, Florida 4155751 33409
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  • East West Med Res Inst

    Honolulu, Hawaii 96814
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  • East West Med Res Inst

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  • MediSphere Medical RC

    Evansville, Indiana 47714
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  • MediSphere Medical RC

    Evansville 4257227, Indiana 4921868 47714
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  • Walgreens - Store 3915

    Las Vegas, Nevada 89146
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  • Walgreens - Store 3915

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  • Chear Center LLC

    The Bronx, New York 10455
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  • Chear Center LLC

    The Bronx 5110266, New York 5128638 10455
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  • Centricity Res New Bern Multispeciality

    New Bern, North Carolina 28562
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  • Accellacare

    Wilmington, North Carolina 28401
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  • Centricity Res New Bern

    New Bern 4481682, North Carolina 4482348 28562
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  • Accellacare

    Wilmington 4499379, North Carolina 4482348 28401
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  • Spartanburg Medical Research

    Spartanburg, South Carolina 29303
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    Spartanburg 4597200, South Carolina 4597040 29303
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    Bristol, Tennessee 37620
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    Dallas, Texas 75230
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    Dallas 4684888, Texas 4736286 75230
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    Richmond, Virginia 23294
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    Richmond 4781708, Virginia 6254928 23294
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