Phase
Condition
Diabetes And Hypertension
Diabetes Mellitus, Type 2
Diabetes Prevention
Treatment
NNC0519-0130
Trizepatide
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
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
Connect with a study center
Macquarie University
Macquarie Park, New South Wales 2109
AustraliaSite Not Available
Royal North Shore Hospital
St Leonards, New South Wales 2065
AustraliaSite Not Available
Roger Chih Yu Chen
Sydney, New South Wales 2148
AustraliaSite Not Available
Western Endocrine Blacktown
Sydney, New South Wales 2148
AustraliaSite Not Available
Illawarra Diabetes Service Clinical Trials & Research Unit
Wollongong, New South Wales 2500
AustraliaActive - Recruiting
University of Sunshine Coast
Birtinya, Queensland 4575
AustraliaSite Not Available
Eastern Clinical Research Unit Box Hill
Box Hill, Victoria 3128
AustraliaActive - Recruiting
Emeritus Research Melbourne
Camberwell, Victoria 3124
AustraliaSite Not Available
Austin Health, Metabolic Disorders Centre
Heidelberg Heights, Victoria 3081
AustraliaSite Not Available
The Royal Melbourne Hospital
Parkville, Victoria 3050
AustraliaActive - Recruiting
OCT Research ULC (dba Okanagan Clinical Trials)
Kelowna, British Columbia V1Y 1Z9
CanadaSite Not Available
OCT Research ULC (dba Okanagan Clinical Trials)
Richmond, British Columbia V6V 2L1
CanadaSite Not Available
Cook Street Medical Clinic
Victoria, British Columbia V8V 4A1
CanadaActive - Recruiting
G.A. Research Associates Ltd.
Moncton, New Brunswick E1G 1A7
CanadaActive - Recruiting
Nova Scotia Hlth Halifax
Halifax, Nova Scotia B3H 1V7
CanadaActive - Recruiting
Wharton Med Clin Trials
Hamilton, Ontario L8L 5G8
CanadaSite Not Available
Albion Finch Medical Centre
Toronto, Ontario M9V 4B4
CanadaSite Not Available
Centricity Research Quebec City
Levis, Quebec G6W 0M5
CanadaCompleted
Recherche GCP Research
Montreal, Quebec H1Y 3H5
CanadaSite Not Available
Centricity Research Ville St. Laurent VSL
Ville Saint-Laurent, Quebec H4T 1Z9
CanadaSite Not Available
Diex Recherche Quebec Inc.
Quebec, G1V 4T3
CanadaSite Not Available
Life Care Clinic & Research Centre
Bangalore, Karnataka 560092
IndiaSite Not Available
Life Care Hospital and Research Centre
Bangalore, Karnataka 560092
IndiaSite Not Available
Amrita Institute Of Medical Sciences & Research Centre
Kochi, Kerala 682041
IndiaSite Not Available
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh 452010
IndiaSite Not Available
Seth GS Medical College & KEM Hospital
Mumbai, Maharashtra 400012
IndiaSite Not Available
Chellaram Diabetes Institute
Pune, Maharashtra 411021
IndiaSite Not Available
Diabetes, Thyroid and Endocrine Centre
Jaipur, Rajasthan 302006
IndiaSite Not Available
Christian Medical College Hospital, Vellore
Vellore, Tamil Nadu 632004
IndiaSite Not Available
Diabetes Research Center, Hyderabad
Hyderabad, Telangana 500082
IndiaSite Not Available
Kumudini Devi Diabetes Research Center, Ramdevrao Hospital
Hyderabad, Telangana 500072
IndiaSite Not Available
MS Ramaiah
Bengaluru, 560054
IndiaSite Not Available
Tokuyama clinic
Chiba, 261-0004
JapanSite Not Available
Soka Sugiura Internal Medicine Clinic
Soka-shi, Saitama, 340-0015
JapanSite Not Available
Fukuwa Clinic
Tokyo, 104-0031
JapanCompleted
Tokyo-Eki Center-building Clinic
Tokyo, 103-0027
JapanSite Not Available
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Kangbuk Samsung Hospital
Seoul, 03181
Korea, Republic ofSite Not Available
Korea University Anam Hospital
Seoul, 02841
Korea, Republic ofSite Not Available
Nowon Eulji Medical Center, Eulji University
Seoul, 01830
Korea, Republic ofSite Not Available
Josha Research
Bloemfontein, Free State 9301
South AfricaSite Not Available
Wits Bara Clinical Trial Site
Johannesburg, Gauteng 2013
South AfricaSite Not Available
Shop#1 Health Emporium
Midrand, Gauteng 1685
South AfricaSite Not Available
Dr Pillay's Rooms
Durban, KwaZulu-Natal 4450
South AfricaSite Not Available
Dr T Padayachee
Umkomaas, KwaZulu-Natal 4170
South AfricaSite Not Available
Velocity Clin Res-Chula Vista
Chula Vista, California 91911
United StatesSite Not Available
Valley Research
Fresno, California 93720
United StatesSite Not Available
310 Clinical Research
Inglewood, California 90301
United StatesSite Not Available
Alliance Clinical Network California
Inglewood, California 90301
United StatesSite Not Available
Velocity Clin Res San Diego
La Mesa, California 91942
United StatesSite Not Available
First Valley Med Grp Lancaster
Lancaster, California 93534
United StatesSite Not Available
Torrance Clin Res Inst, Inc.
Lomita, California 90717
United StatesActive - Recruiting
Pacific Clinical Studies
Los Alamitos, California 90720
United StatesActive - Recruiting
Catalina Research Institute, LLC
Montclair, California 91763
United StatesSite Not Available
Med Partners, Inc.
Toluca Lake, California 91602
United StatesCompleted
UCLA Health Southbay Endocrine
Torrance, California 90505
United StatesSite Not Available
University Clin Investigators
Tustin, California 92780
United StatesSite Not Available
Diablo Clinical Research, Inc.
Walnut Creek, California 94598
United StatesSite Not Available
University of Colorado Hospital
Aurora, Colorado 80045
United StatesSite Not Available
Innovative Research of W FL
Clearwater, Florida 33756
United StatesSite Not Available
Innovative Research of W Florida Inc.
Clearwater, Florida 33756
United StatesActive - Recruiting
International Research Associates, LLC_Miami
Miami, Florida 33183
United StatesSite Not Available
Centricity Research
Columbus, Georgia 31904
United StatesSite Not Available
Elite Clinical Trials
Blackfoot, Idaho 83221
United StatesSite Not Available
Elite Clinical Trials
Rexburg, Idaho 83440
United StatesSite Not Available
Methodist Medical Center of Illinois
Peoria, Illinois 61603
United StatesSite Not Available
Methodist Medical_Center of Illinois
Peoria, Illinois 61636
United StatesActive - Recruiting
Centennial Medical Group
Columbia, Maryland 21045
United StatesSite Not Available
MD Medical Research
Oxon Hill, Maryland 20745
United StatesActive - Recruiting
Endo And Metab Cons
Rockville, Maryland 20852
United StatesSite Not Available
Clinvest Research
Springfield, Missouri 65807
United StatesSite Not Available
Mercury Str Med Grp, PLLC
Butte, Montana 59701
United StatesCompleted
Excel Clinical Network
Las Vegas, Nevada 89109
United StatesSite Not Available
Palm Research Center Inc-Vegas
Las Vegas, Nevada 89128
United StatesSite Not Available
Velocity Clinical Research Binghamton
Binghamton, New York 13905
United StatesSite Not Available
PharmQuest Life Sciences LLC
Greensboro, North Carolina 27408
United StatesSite Not Available
Accellacare Wilmington
Wilmington, North Carolina 28401
United StatesSite Not Available
Diab & Endo Assoc of Stark Co
Canton, Ohio 44718
United StatesSite Not Available
Velocity Clin Res_Cincinnati
Cincinnati, Ohio 45242
United StatesSite Not Available
Velocity Clinical Research Springdale
Cincinnati, Ohio 45246
United StatesActive - Recruiting
Providence Health Partners Ctr
Dayton, Ohio 45439
United StatesCompleted
Advanced Med Res Maumee
Maumee, Ohio 43537
United StatesSite Not Available
Tristar Clin Investigations, PC
Philadelphia, Pennsylvania 19114
United StatesSite Not Available
Preferred Primary Care Physicians Inc.
Pittsburgh, Pennsylvania 15243
United StatesSite Not Available
Preferred Primary Care Physicians, Inc.
Uniontown, Pennsylvania 15401
United StatesSite Not Available
Velocity Clinical Research Abilene
Abilene, Texas 79606
United StatesSite Not Available
Velocity Clin Res Austin
Austin, Texas 78759
United StatesSite Not Available
Alliance Clinical Network Dallas
Dallas, Texas 75203
United StatesSite Not Available
Velocity Clinical Res-Dallas
Dallas, Texas 75230
United StatesSite Not Available
Zenos Clinical research
Dallas, Texas 75230
United StatesCompleted
Care United Research, LLC
Forney, Texas 75126
United StatesSite Not Available
Biopharma Informatic_Houston
Houston, Texas 77043
United StatesSite Not Available
Endocrine Associates Houston
Houston, Texas 77004
United StatesSite Not Available
Tekton Research
Irving, Texas 75039
United StatesSite Not Available
Alliance Clinical Network Lewisville
Lewisville, Texas 75057
United StatesSite Not Available
Epic Clinical Research
Lewisville, Texas 75057
United StatesSite Not Available
Consano Clinical Research, LLC
Shavano Park, Texas 78231
United StatesSite Not Available
Burke Internal Medicine & Research
Burke, Virginia 22015
United StatesSite Not Available
TPMG Clinical Research
Newport News, Virginia 23606
United StatesCompleted
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