A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes

Last updated: April 15, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Diabetes Prevention

Treatment

NNC0519-0130

Trizepatide

Placebo

Clinical Study ID

NCT06326047
NN9541-4945
jRCT2031230704
U1111-1291-9196
  • Ages 18-75
  • All Genders

Study Summary

This study will look at how well a new medicine called NNC0519-0130 helps people with type 2 diabetes lower their blood sugar and body weight. The study will test up to 7 different doses of NNC0519-0130. Which treatment participant will get is decided by chance. Participants will take 1-3 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 40 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female of non-childbearing potential, or male.

  • For United States (US) only: Female of childbearing potential using highly effectivenon-systemic methods of contraception with low user-dependency and willingness tocontinue using it through-out the study or male.

  • Age 18-75 years (both inclusive) at the time of signing the informed consent.

  • Diagnosed with type 2 diabetes mellitus greater than or equal 180 days beforescreening.

  • Stable daily dose(s) more than or equal 90 days before screening of the followingantidiabetic drug(s) or combination regimen(s) at effective or maximum tolerateddose as judged by the investigator: metformin with or without sodium-glucoseco-transporter 2 (SGLT2) inhibitor.

  • Glycated haemoglobin (HbA1c) of 7.5-10.0% (58-86 millimoles per moles (mmol/mol)) (both inclusive) as assessed by central laboratory at screening.

  • Body mass index (BMI) greater than or equal 23.0 kilograms per meter square (kg/m^2).

Exclusion

Exclusion Criteria:

  • Treatment with any medication for the indication of diabetes or obesity other thanstated in the inclusion criteria within 90 days before screening. 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.

  • Known hypoglycaemic unawareness as indicated by the investigator according toClarke's questionnaire question.

Study Design

Total Participants: 288
Treatment Group(s): 3
Primary Treatment: NNC0519-0130
Phase: 2
Study Start date:
March 18, 2024
Estimated Completion Date:
October 13, 2025

Connect with a study center

  • Macquarie University

    Macquarie Park, New South Wales 2109
    Australia

    Site Not Available

  • Royal North Shore Hospital

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Roger Chih Yu Chen

    Sydney, New South Wales 2148
    Australia

    Site Not Available

  • Western Endocrine Blacktown

    Sydney, New South Wales 2148
    Australia

    Site Not Available

  • Illawarra Diabetes Service Clinical Trials & Research Unit

    Wollongong, New South Wales 2500
    Australia

    Active - Recruiting

  • University of Sunshine Coast

    Birtinya, Queensland 4575
    Australia

    Site Not Available

  • Eastern Clinical Research Unit Box Hill

    Box Hill, Victoria 3128
    Australia

    Active - Recruiting

  • Emeritus Research Melbourne

    Camberwell, Victoria 3124
    Australia

    Site Not Available

  • Austin Health, Metabolic Disorders Centre

    Heidelberg Heights, Victoria 3081
    Australia

    Site Not Available

  • The Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Active - Recruiting

  • OCT Research ULC (dba Okanagan Clinical Trials)

    Kelowna, British Columbia V1Y 1Z9
    Canada

    Site Not Available

  • OCT Research ULC (dba Okanagan Clinical Trials)

    Richmond, British Columbia V6V 2L1
    Canada

    Site Not Available

  • Cook Street Medical Clinic

    Victoria, British Columbia V8V 4A1
    Canada

    Active - Recruiting

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick E1G 1A7
    Canada

    Active - Recruiting

  • Nova Scotia Hlth Halifax

    Halifax, Nova Scotia B3H 1V7
    Canada

    Active - Recruiting

  • Wharton Med Clin Trials

    Hamilton, Ontario L8L 5G8
    Canada

    Site Not Available

  • Albion Finch Medical Centre

    Toronto, Ontario M9V 4B4
    Canada

    Site Not Available

  • Centricity Research Quebec City

    Levis, Quebec G6W 0M5
    Canada

    Completed

  • Recherche GCP Research

    Montreal, Quebec H1Y 3H5
    Canada

    Site Not Available

  • Centricity Research Ville St. Laurent VSL

    Ville Saint-Laurent, Quebec H4T 1Z9
    Canada

    Site Not Available

  • Diex Recherche Quebec Inc.

    Quebec, G1V 4T3
    Canada

    Site Not Available

  • Life Care Clinic & Research Centre

    Bangalore, Karnataka 560092
    India

    Site Not Available

  • Life Care Hospital and Research Centre

    Bangalore, Karnataka 560092
    India

    Site Not Available

  • Amrita Institute Of Medical Sciences & Research Centre

    Kochi, Kerala 682041
    India

    Site Not Available

  • TOTALL Diabetes Hormone Institute

    Indore, Madhya Pradesh 452010
    India

    Site Not Available

  • Seth GS Medical College & KEM Hospital

    Mumbai, Maharashtra 400012
    India

    Site Not Available

  • Chellaram Diabetes Institute

    Pune, Maharashtra 411021
    India

    Site Not Available

  • Diabetes, Thyroid and Endocrine Centre

    Jaipur, Rajasthan 302006
    India

    Site Not Available

  • Christian Medical College Hospital, Vellore

    Vellore, Tamil Nadu 632004
    India

    Site Not Available

  • Diabetes Research Center, Hyderabad

    Hyderabad, Telangana 500082
    India

    Site Not Available

  • Kumudini Devi Diabetes Research Center, Ramdevrao Hospital

    Hyderabad, Telangana 500072
    India

    Site Not Available

  • MS Ramaiah

    Bengaluru, 560054
    India

    Site Not Available

  • Tokuyama clinic

    Chiba, 261-0004
    Japan

    Site Not Available

  • Soka Sugiura Internal Medicine Clinic

    Soka-shi, Saitama, 340-0015
    Japan

    Site Not Available

  • Fukuwa Clinic

    Tokyo, 104-0031
    Japan

    Completed

  • Tokyo-Eki Center-building Clinic

    Tokyo, 103-0027
    Japan

    Site Not Available

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Kangbuk Samsung Hospital

    Seoul, 03181
    Korea, Republic of

    Site Not Available

  • Korea University Anam Hospital

    Seoul, 02841
    Korea, Republic of

    Site Not Available

  • Nowon Eulji Medical Center, Eulji University

    Seoul, 01830
    Korea, Republic of

    Site Not Available

  • Josha Research

    Bloemfontein, Free State 9301
    South Africa

    Site Not Available

  • Wits Bara Clinical Trial Site

    Johannesburg, Gauteng 2013
    South Africa

    Site Not Available

  • Shop#1 Health Emporium

    Midrand, Gauteng 1685
    South Africa

    Site Not Available

  • Dr Pillay's Rooms

    Durban, KwaZulu-Natal 4450
    South Africa

    Site Not Available

  • Dr T Padayachee

    Umkomaas, KwaZulu-Natal 4170
    South Africa

    Site Not Available

  • Velocity Clin Res-Chula Vista

    Chula Vista, California 91911
    United States

    Site Not Available

  • Valley Research

    Fresno, California 93720
    United States

    Site Not Available

  • 310 Clinical Research

    Inglewood, California 90301
    United States

    Site Not Available

  • Alliance Clinical Network California

    Inglewood, California 90301
    United States

    Site Not Available

  • Velocity Clin Res San Diego

    La Mesa, California 91942
    United States

    Site Not Available

  • First Valley Med Grp Lancaster

    Lancaster, California 93534
    United States

    Site Not Available

  • Torrance Clin Res Inst, Inc.

    Lomita, California 90717
    United States

    Active - Recruiting

  • Pacific Clinical Studies

    Los Alamitos, California 90720
    United States

    Active - Recruiting

  • Catalina Research Institute, LLC

    Montclair, California 91763
    United States

    Site Not Available

  • Med Partners, Inc.

    Toluca Lake, California 91602
    United States

    Completed

  • UCLA Health Southbay Endocrine

    Torrance, California 90505
    United States

    Site Not Available

  • University Clin Investigators

    Tustin, California 92780
    United States

    Site Not Available

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • University of Colorado Hospital

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Innovative Research of W FL

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Innovative Research of W Florida Inc.

    Clearwater, Florida 33756
    United States

    Active - Recruiting

  • International Research Associates, LLC_Miami

    Miami, Florida 33183
    United States

    Site Not Available

  • Centricity Research

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Elite Clinical Trials

    Blackfoot, Idaho 83221
    United States

    Site Not Available

  • Elite Clinical Trials

    Rexburg, Idaho 83440
    United States

    Site Not Available

  • Methodist Medical Center of Illinois

    Peoria, Illinois 61603
    United States

    Site Not Available

  • Methodist Medical_Center of Illinois

    Peoria, Illinois 61636
    United States

    Active - Recruiting

  • Centennial Medical Group

    Columbia, Maryland 21045
    United States

    Site Not Available

  • MD Medical Research

    Oxon Hill, Maryland 20745
    United States

    Active - Recruiting

  • Endo And Metab Cons

    Rockville, Maryland 20852
    United States

    Site Not Available

  • Clinvest Research

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Mercury Str Med Grp, PLLC

    Butte, Montana 59701
    United States

    Completed

  • Excel Clinical Network

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Palm Research Center Inc-Vegas

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Velocity Clinical Research Binghamton

    Binghamton, New York 13905
    United States

    Site Not Available

  • PharmQuest Life Sciences LLC

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Accellacare Wilmington

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Diab & Endo Assoc of Stark Co

    Canton, Ohio 44718
    United States

    Site Not Available

  • Velocity Clin Res_Cincinnati

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Velocity Clinical Research Springdale

    Cincinnati, Ohio 45246
    United States

    Active - Recruiting

  • Providence Health Partners Ctr

    Dayton, Ohio 45439
    United States

    Completed

  • Advanced Med Res Maumee

    Maumee, Ohio 43537
    United States

    Site Not Available

  • Tristar Clin Investigations, PC

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Preferred Primary Care Physicians Inc.

    Pittsburgh, Pennsylvania 15243
    United States

    Site Not Available

  • Preferred Primary Care Physicians, Inc.

    Uniontown, Pennsylvania 15401
    United States

    Site Not Available

  • Velocity Clinical Research Abilene

    Abilene, Texas 79606
    United States

    Site Not Available

  • Velocity Clin Res Austin

    Austin, Texas 78759
    United States

    Site Not Available

  • Alliance Clinical Network Dallas

    Dallas, Texas 75203
    United States

    Site Not Available

  • Velocity Clinical Res-Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Zenos Clinical research

    Dallas, Texas 75230
    United States

    Completed

  • Care United Research, LLC

    Forney, Texas 75126
    United States

    Site Not Available

  • Biopharma Informatic_Houston

    Houston, Texas 77043
    United States

    Site Not Available

  • Endocrine Associates Houston

    Houston, Texas 77004
    United States

    Site Not Available

  • Tekton Research

    Irving, Texas 75039
    United States

    Site Not Available

  • Alliance Clinical Network Lewisville

    Lewisville, Texas 75057
    United States

    Site Not Available

  • Epic Clinical Research

    Lewisville, Texas 75057
    United States

    Site Not Available

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • Burke Internal Medicine & Research

    Burke, Virginia 22015
    United States

    Site Not Available

  • TPMG Clinical Research

    Newport News, Virginia 23606
    United States

    Completed

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