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Clinical Trial Details

Trial ID: L6781
Source ID: NCT06326047
Associated Drug: Nnc0519-0130
Title: A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Lower Blood Sugar in People With Type 2 Diabetes
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: NNC0519-0130|DRUG: Placebo|DRUG: Trizepatide
Outcome Measures: Primary: Change in Glycated haemoglobin (HbA1c), Measured as percentage point (%-point), From baseline (week 0) to 12 weeks on a given maintenance dose | Secondary: 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 (%), 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)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 288
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03-18
Completion Date: 2025-10-13
Results First Posted:
Last Update Posted: 2025-04-09
Locations: Velocity Clin Res-Chula Vista, Chula Vista, California, 91911, United States|Valley Research, Fresno, California, 93720, United States|Valley Research, 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|Torrance Clin Res Inst, Inc., Lomita, California, 90717, United States|Pacific Clinical Studies, Los Alamitos, California, 90720, United States|Pacific Clinical Studies, Los Alamitos, California, 90720, United States|Catalina Research Institute, LLC, Montclair, California, 91763, 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|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|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, 89128, 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|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 Clin Res_Cincinnati, Cincinnati, Ohio, 45242, United States|Velocity Clinical Research Springdale, Cincinnati, Ohio, 45246, 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|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|Biopharma Informatic_Houston, Houston, Texas, 77043, United States|Tekton Research, Irving, Texas, 75039, 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|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|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|Austin Health, Metabolic Disorders Centre, Heidelberg Heights, Victoria, 3081, Australia|The Royal Melbourne Hospital, Parkville, Victoria, 3050, 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), Kelowna, British Columbia, V1Y 1Z9, Canada|OCT Research ULC (dba Okanagan Clinical Trials), Richmond, British Columbia, V6V 2L1, Canada|OCT Research ULC (dba Okanagan Clinical Trials), Richmond, British Columbia, V6V 2L1, Canada|Cook Street Medical Clinic, Victoria, British Columbia, V8V 4A1, Canada|Cook Street Medical Clinic, Victoria, British Columbia, V8V 4A1, Canada|G.A. Research Associates Ltd., Moncton, New Brunswick, E1G 1A7, Canada|G.A. Research Associates Ltd., Moncton, New Brunswick, E1G 1A7, Canada|Nova Scotia Hlth Halifax, Halifax, Nova Scotia, B3H 1V7, 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|Albion Finch Medical Centre, Toronto, Ontario, M9V 4B4, Canada|Centricity Research Quebec City, Levis, Quebec, G6W 0M5, Canada|Recherche GCP Research, Montreal, Quebec, H1Y 3H5, Canada|Centricity Research Ville St. Laurent VSL, Ville Saint-Laurent, Quebec, H4T 1Z9, Canada|Diex Recherche Quebec Inc., Quebec, 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|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, Chiba, 261-0004, Japan|Soka Sugiura Internal Medicine Clinic, Soka-shi, Saitama, 340-0015, Japan|Soka Sugiura Internal Medicine Clinic, Soka-shi, Saitama, 340-0015, Japan|Tokyo-Eki Center-building Clinic, Tokyo, 103-0027, Japan|Fukuwa Clinic, Tokyo, 104-0031, Japan|Fukuwa Clinic, Tokyo, 104-0031, Japan|Seoul National University Bundang Hospital, Gyeonggi-do, 13620, Korea, Republic of|Nowon Eulji Medical Center, Eulji University, Seoul, 01830, Korea, Republic of|Korea University Anam Hospital, Seoul, 02841, Korea, Republic of|Kangbuk Samsung Hospital, Seoul, 03181, Korea, Republic of|Asan Medical Center, Seoul, 05505, Korea, Republic of|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, Umkomaas, KwaZulu-Natal, 4170, South Africa
URL: https://clinicaltrials.gov/show/NCT06326047

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress