A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise

Last updated: April 20, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Not Recruiting

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Treatment

Semaglutide

Cagrilintide

Placebo

Clinical Study ID

NCT06323174
NN9388-4895
U1111-1283-0404
2022-502677-42
  • Ages > 18
  • All Genders

Study Summary

This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female

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

  • Diagnosed with type 2 diabetes >=30 days before screening

  • HbA1c 7.0-9.5 percent (53-80 millimoles per mole [mmol/mol]) (both inclusive) asdetermined by central laboratory at screening

  • Body mass index (BMI) >=23 kilograms per square meter (kg/m^2) at screening. BMIwill be calculated in the electronic case report form (eCRF) based on height andbody weight at screening

Exclusion

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is ofchildbearing potential and not using a highly effective contraceptive method

  • Renal impairment with estimated Glomerular Filtration Rate less than 30 milliliterper minute per 1.73 square meter (ml/min/1.73 m^2) as determined by centrallaboratory at screening

  • Treatment with any medication for the indication of diabetes or obesity within 90days before screening. However, short term insulin treatment for a maximum of 14consecutive days and prior insulin treatment for gestational diabetes are allowed

  • History of use of any injectable therapy for diabetes or obesity. However, shortterm insulin treatment for a maximum of 14 consecutive days and prior insulintreatment for gestational diabetes are allowed

  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verifiedby a fundus examination performed within 90 days before screening or in the periodbetween screening and randomisation. Pharmacological pupil-dilation is a requirementunless using a digital fundus photography camera specified for non-dilatedexamination

Study Design

Total Participants: 180
Treatment Group(s): 3
Primary Treatment: Semaglutide
Phase: 3
Study Start date:
March 19, 2024
Estimated Completion Date:
December 26, 2025

Connect with a study center

  • Chinese People's Liberation Army General Hospital

    Beijing, Beijing 100853
    China

    Active - Recruiting

  • Chinese People's Liberation Army General Hospital-Endocrinology

    Beijing, Beijing 100853
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology

    Nanjing, Jiangsu 210011
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanjing Medical University_Nanjing

    Nanjing, Jiangsu 210011
    China

    Active - Recruiting

  • The Affiliated Hospital of Jiangsu University-Endocrinology

    Zhenjiang, Jiangsu 212001
    China

    Site Not Available

  • The Affiliated Hospital of Jiangsu University_Zhenjiang

    Zhenjiang, Jiangsu 212001
    China

    Active - Recruiting

  • Jinan Central Hospital

    Ji'Nan, Shandong 250000
    China

    Site Not Available

  • Belinus Bt.

    Debrecen, Hajdu-Bihar Varmegye 4025
    Hungary

    Site Not Available

  • Borbánya Praxis E.Ü. Kft.

    Nyíregyháza, Szabolcs-Szatmar Varmegye 4405
    Hungary

    Site Not Available

  • PVN Kutato Kft.

    Budapest, 1102
    Hungary

    Site Not Available

  • Szent Margit Rendelőintézet Nonprofit Kft.

    Budapest, 1032
    Hungary

    Site Not Available

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127
    Italy

    Site Not Available

  • Policlinico Mater Domini Università di Catanzaro

    Catanzaro, 88100
    Italy

    Site Not Available

  • IRCCS Ospedale San Raffaele Milano

    Milano, 20132
    Italy

    Site Not Available

  • Azienda Ospealiero Universitaria Policlinico Umberto I

    Roma, 00161
    Italy

    Site Not Available

  • Centrum Medyczne Medyk Sp. z o.o.

    Rzeszow, Podkarpackie 35-055
    Poland

    Site Not Available

  • Osteo-Medic s.c. A. Racewicz, J. Supronik

    Bialystok, 15-351
    Poland

    Site Not Available

  • Renew Clinic Bialystok

    Białystok, 15-797
    Poland

    Site Not Available

  • Renew Clinic Sp. z o.o.

    Białystok, 15-797
    Poland

    Site Not Available

  • Centrum Terapii Wspolczesnej

    Lodz, 90-338
    Poland

    Active - Recruiting

  • Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A.

    Lodz, 90-338
    Poland

    Site Not Available

  • NBR Polska Tomasz Klodawski

    Warszawa, 00-710
    Poland

    Site Not Available

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

    Warszawa, 02-507
    Poland

    Site Not Available

  • Velocity Nova Sp. z o.o.

    Zamość, 22-400
    Poland

    Site Not Available

  • King Abdulaziz Hospital-Al Ahsa-National Guard

    Al Ahsa, 36428
    Saudi Arabia

    Site Not Available

  • National Guard Hospital - Jeddah

    Jeddah, 21423
    Saudi Arabia

    Site Not Available

  • King Fahad Medical City

    Riyadh, 11525
    Saudi Arabia

    Site Not Available

  • King Khaled University Hospital,King Saud Univ. Med. City

    Riyadh, 12372
    Saudi Arabia

    Site Not Available

  • King Salman Bin Abdulaziz Hospital

    Riyadh, 12769
    Saudi Arabia

    Site Not Available

  • CHC Zvezdara, Clinical department for endocrinology

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11080
    Serbia

    Site Not Available

  • Clinical Hospital Centre Zemun

    Belgrade, 11080
    Serbia

    Site Not Available

  • Policlinic for diabetes

    Zajecar, 19000
    Serbia

    Site Not Available

  • Nat Res Inst Huntington Park

    Huntington Park, California 90255
    United States

    Site Not Available

  • National Research Institute_Huntington Park

    Huntington Park, California 90255
    United States

    Site Not Available

  • Valley Clinical Trials, Inc.

    Northridge, California 91325
    United States

    Site Not Available

  • Southern California Dermatology

    Santa Ana, California 92701
    United States

    Site Not Available

  • Encore Medical Research LLC

    Hollywood, Florida 33024
    United States

    Site Not Available

  • Headlands Research Orlando

    Orlando, Florida 32819
    United States

    Site Not Available

  • Encore Medical Research of Weston

    Weston, Florida 33331
    United States

    Site Not Available

  • Alliance for Multispec Res

    Newton, Kansas 67114
    United States

    Site Not Available

  • Brigham & Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Arcturus Healthcare, PLC

    Troy, Michigan 48098
    United States

    Site Not Available

  • Southgate Medical Group, LLP

    West Seneca, New York 14224
    United States

    Site Not Available

  • Summit Research Network Oregon Inc.

    Portland, Oregon 97210
    United States

    Site Not Available

  • Holston Medical Group

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • Amarillo Medical Specialists

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Elligo Clin Res Centre

    Austin, Texas 78704
    United States

    Site Not Available

  • Headlands Research Brownsville

    Brownsville, Texas 78526
    United States

    Site Not Available

  • Velocity Clinical Res-Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Northeast Clinical Research of San Antonio

    San Antonio, Texas 78233
    United States

    Site Not Available

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Sugar Lakes Family Practice PA

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • Valley Diab. & Endo Comp Ctr

    Weslaco, Texas 78596
    United States

    Site Not Available

  • TPMG Clinical Research

    Newport News, Virginia 23606
    United States

    Site Not Available

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