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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1291-9196 | Other Identifier | World Health Organization (WHO) | |
| jRCT2031230704 | Registry Identifier | JRCT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosing scheme A (NNC0519-0130) | Experimental | Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as subcutaneous (s.c.) injection in dose escalating manner. |
|
| Dosing scheme A (Placebo) | Placebo Comparator | Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods. |
|
| Dosing scheme B (NNC0519-0130) | Experimental | Participants will receive NNC0519-0130 at 3 dose levels once weekly (QW) as s.c. injection in dose escalating manner. |
|
| Dosing scheme B (Placebo) | Placebo Comparator | Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods. |
|
| Dosing scheme C (NNC0519-0130) | Experimental | Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner. |
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| Dosing scheme C (Placebo) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0519-0130 | Drug | NNC0519-0130 will be administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycated haemoglobin (HbA1c) | Measured as percentage point (%-point) | From baseline (week 0) to 12 weeks on a given maintenance dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycated haemoglobin (HbA1c) | Measured as percentage point (%-point) | From baseline (week 0) to end of treatment (week 36) |
| Relative change in body weight | Measured as percentage (%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Clin Res-Chula Vista | Chula Vista | California | 91911 | United States | ||
| Valley Research |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Sponsor staff involved in the clinical trial is masked according to company standard procedures. The study will be double-blinded within dose level of once weekly subcutaneously administered NNC0519-0130 and the corresponding volume-matched placebo arms. The active comparator arm with tirzepatide will be open label.
| Placebo Comparator |
Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods. |
|
| Dosing scheme D (NNC0519-0130) | Experimental | Participants will receive NNC0519-0130 at 5 dose levels once weekly as s.c. injection in dose escalating manner. |
|
| Dosing scheme D (Placebo) | Placebo Comparator | Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods. |
|
| Dosing scheme E (NNC0519-0130) | Experimental | Participants will receive NNC0519-0130 at 7 dose levels once weekly as s.c. injection in dose escalating manner. |
|
| Dosing scheme E (Placebo) | Placebo Comparator | Participants will receive NNC0519-0130 matched placebo once weekly s.c. for 3 periods. |
|
| Dosing scheme F (tirzepatide) | Active Comparator | Participants will receive tirzepatide at 6 dose levels once weekly as s.c. injection in dose escalating manner. |
|
| Placebo | Drug | Placebo will be administered subcutaneously. |
|
| Trizepatide | Drug | Trizepatide will be administered subcutaneously. |
|
| From baseline (week 0) to end of treatment (week 36) |
| Change in body weight | Measured as kilograms (kg) | From baseline (week 0) to end of treatment (week 36) |
| Change in fasting plasma glucose (FPG) | Measured as millimoles per liter (mmol/L) | From baseline (week 0) to 12 weeks on a given maintenance dose |
| Continuous glucose monitoring (CGM): Change in time in range (TIR) 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL)) | Measured as percentage point (%-point) | From baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively |
| Change in waist circumference | Measured as centimeter (cm) | From baseline (week 0) to end of treatment (week 36) |
| Change in systolic blood pressure (SBP) | Measured as millimeters of mercury (mmHg) | From baseline (week 0) to end of treatment (week 36) |
| Change in high sensitivity C-Reactive Protein (hsCRP) | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 36) |
| Change in total cholesterol | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 36) |
| Change in high-density lipoprotein (HDL) cholesterol | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 36) |
| Change in low-density lipoprotein (LDL) cholesterol | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 36) |
| Change in triglycerides | Measured as ratio to baseline | From baseline (week 0) to end of treatment (week 36) |
| Number of adverse events | Measured as number of events | From baseline (week 0) to end of study (week 40) |
| Fresno |
| California |
| 93720 |
| United States |
| 310 Clinical Research | Inglewood | California | 90301 | United States |
| Velocity Clin Res San Diego | La Mesa | California | 91942 | United States |
| First Valley Med Grp Lancaster | Lancaster | California | 93534 | United States |
| Torrance Clin Res Inst, Inc. | Lomita | California | 90717 | United States |
| Pacific Clinical Studies | Los Alamitos | California | 90720 | United States |
| Catalina Research Institute, LLC | Montclair | California | 91763 | United States |
| Med Partners, Inc. | Toluca Lake | California | 91602 | United States |
| UCLA Health Southbay Endocrine | Torrance | California | 90505 | United States |
| University Clin Investigators | Tustin | California | 92780 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Innovative Research of W Florida Inc. | Clearwater | Florida | 33756 | United States |
| Innovative Research of W FL | Clearwater | Florida | 33756 | United States |
| International Research Associates, LLC_Miami | Miami | Florida | 33183 | United States |
| Centricity Research | Columbus | Georgia | 31904 | United States |
| Elite Clinical Trials | Blackfoot | Idaho | 83221 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61603 | United States |
| Centennial Medical Group | Columbia | Maryland | 21045 | United States |
| MD Medical Research | Oxon Hill | Maryland | 20745 | United States |
| Endo And Metab Cons | Rockville | Maryland | 20852 | United States |
| Clinvest Research | Springfield | Missouri | 65807 | United States |
| Mercury Str Med Grp, PLLC | Butte | Montana | 59701 | United States |
| Excel Clinical Network | Las Vegas | Nevada | 89109 | United States |
| Palm Research Center Inc-Vegas | Las Vegas | Nevada | 89148 | United States |
| Velocity Clinical Research Binghamton | Binghamton | New York | 13905 | United States |
| PharmQuest Life Sciences LLC | Greensboro | North Carolina | 27408 | United States |
| Accellacare Wilmington | Wilmington | North Carolina | 28401 | United States |
| Diab & Endo Assoc of Stark Co | Canton | Ohio | 44718 | United States |
| Velocity Clin Res_Cincinnati | Cincinnati | Ohio | 45242 | United States |
| Velocity Clinical Research Springdale | Cincinnati | Ohio | 45246 | United States |
| Providence Health Partners Ctr | Dayton | Ohio | 45439 | United States |
| Advanced Med Res Maumee | Maumee | Ohio | 43537 | United States |
| Tristar Clin Investigations, PC | Philadelphia | Pennsylvania | 19114 | United States |
| Preferred Primary Care Physicians Inc. | Pittsburgh | Pennsylvania | 15243 | United States |
| Preferred Primary Care Physicians, Inc. | Uniontown | Pennsylvania | 15401 | United States |
| Velocity Clinical Research Abilene | Abilene | Texas | 79606 | United States |
| Tekton Research | Austin | Texas | 75039 | United States |
| Velocity Clin Res Austin | Austin | Texas | 78759 | United States |
| Velocity Clinical Res-Dallas | Dallas | Texas | 75230 | United States |
| Zenos Clinical research | Dallas | Texas | 75230 | United States |
| Care United Research, LLC | Forney | Texas | 75126 | United States |
| Endocrine Associates Houston | Houston | Texas | 77004 | United States |
| Biopharma Informatic_Houston | Houston | Texas | 77043 | United States |
| Epic Clinical Research | Lewisville | Texas | 75057 | United States |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
| Burke Internal Medicine & Research | Burke | Virginia | 22015 | United States |
| TPMG Clinical Research | Newport News | Virginia | 23606 | United States |
| Macquarie University | Macquarie Park | New South Wales | 2109 | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| Roger Chih Yu Chen | Sydney | New South Wales | 2148 | Australia |
| Western Endocrine Blacktown | Sydney | New South Wales | 2148 | Australia |
| Illawarra Diabetes Service Clinical Trials & Research Unit | Wollongong | New South Wales | 2500 | Australia |
| University of Sunshine Coast | Birtinya | Queensland | 4575 | Australia |
| Eastern Clinical Research Unit Box Hill | Box Hill | Victoria | 3128 | Australia |
| Emeritus Research Melbourne | Camberwell | Victoria | 3124 | Australia |
| Austin Health, Metabolic Disorders Centre | Heidelberg Heights | Victoria | 3081 | Australia |
| The Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| OCT Research ULC (dba Okanagan Clinical Trials) | Kelowna | British Columbia | V1Y 1Z9 | Canada |
| OCT Research ULC (dba Okanagan Clinical Trials) | Richmond | British Columbia | V6V 2L1 | Canada |
| Cook Street Medical Clinic | Victoria | British Columbia | V8V 4A1 | Canada |
| G.A. Research Associates Ltd. | Moncton | New Brunswick | E1G 1A7 | Canada |
| Nova Scotia Hlth Halifax | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Wharton Med Clin Trials | Hamilton | Ontario | L8L 5G8 | Canada |
| Albion Finch Medical Centre | Toronto | Ontario | M9V 4B4 | Canada |
| Centricity Research Quebec City | Lévis | Quebec | G6W 0M5 | Canada |
| Recherche GCP Research | Montreal | Quebec | H1Y 3H5 | Canada |
| Centricity Research Ville St. Laurent VSL | Saint-Laurent | Quebec | H4T 1Z9 | Canada |
| Diex Recherche Quebec Inc. | Québec | G1V 4T3 | Canada |
| Life Care Hospital and Research Centre | Bangalore | Karnataka | 560092 | India |
| Amrita Institute Of Medical Sciences & Research Centre | Kochi | Kerala | 682041 | India |
| TOTALL Diabetes Hormone Institute | Indore | Madhya Pradesh | 452010 | India |
| Seth GS Medical College & KEM Hospital | Mumbai | Maharashtra | 400012 | India |
| Chellaram Diabetes Institute | Pune | Maharashtra | 411021 | India |
| Diabetes, Thyroid and Endocrine Centre | Jaipur | Rajasthan | 302006 | India |
| Christian Medical College Hospital, Vellore | Vellore | Tamil Nadu | 632004 | India |
| Diabetes Research Center, Hyderabad | Hyderabad | Telangana | 500082 | India |
| MS Ramaiah | Bengaluru | 560054 | India |
| Tokuyama clinic_Diabetic internal medicine | Chiba | 261-0004 | Japan |
| Soka Sugiura Internal Medicine Clinic | Soka-shi, Saitama | 340-0015 | Japan |
| Tokyo-Eki Center-building Clinic_Internal Medicine | Tokyo | 103-0027 | Japan |
| Fukuwa Clinic_Internal Medicine | Tokyo | 104-0031 | Japan |
| Fukuwa Clinic | Tokyo | 104-0031 | Japan |
| Josha Research | Bloemfontein | Free State | 9301 | South Africa |
| Wits Bara Clinical Trial Site | Johannesburg | Gauteng | 2013 | South Africa |
| Shop#1 Health Emporium | Midrand | Gauteng | 1685 | South Africa |
| Dr Pillay's Rooms | Durban | KwaZulu-Natal | 4450 | South Africa |
| Dr T Padayachee | eMkhomazi | KwaZulu-Natal | 4170 | South Africa |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Nowon Eulji Medical Center, Eulji University | Seoul | 01830 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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