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Clinical Trial Details

Trial ID: L3483
Source ID: NCT05144984
Associated Drug: Nnc0480-0389
Title: A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: NNC0480-0389|DRUG: Semaglutide|DRUG: Placebo (NNC080-0389)|DRUG: Placebo (semaglutide)
Outcome Measures: Primary: Change in HbA1c, percentage-point, From baseline (week 0) to visit 24 (week 34) | Secondary: Change in fasting plasma glucose (FPG), measured in mmol/L, From baseline (week 0) to visit 24 (week 34)|Change in body weight (kg), measured in kg, From baseline (week 0) to visit 24 (week 34)|Change in body weight (%), measured in percent, From baseline (week 0) to visit 24 (week 34)|Change in waist circumference, measured in cm, From baseline (week 0) to visit 24 (week 34)|Change in systolic blood pressure (SBP), measured in mmHg, From baseline (week 0) to visit 24 (week 34)|Relative change in total cholesterol, ratio, From baseline (week 0) to visit 24 (week 34)|Relative change in high-density lipoprotein (HDL) cholesterol, ratio, From baseline (week 0) to visit 24 (week 34)|Relative change in low-density lipoprotein (LDL) cholesterol, ratio, From baseline (week 0) to visit 24 (week 34)|Relative change in very-low-density lipoprotein (VLDL) cholesterol, ratio, From baseline (week 0) to visit 24 (week 34)|Relative change in triglycerides, ratio, From baseline (week 0) to visit 24 (week 34)|Relative change in free fatty acids, ratio, From baseline (week 0) to visit 24 (week 34)|Relative change in Apolipoprotein B (ApoB), ratio, From baseline (week 0) to visit 24 (week 34)|Relative change in high sensitivity C-Reactive Protein (hsCRP), ratio, From baseline (week 0) to visit 24 (week 34)|Number of treatment-emergent adverse events (TEAEs), Count of events, From baseline (week 0) to visit 25 (week 39)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 500
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-11-29
Completion Date: 2023-03-23
Results First Posted:
Last Update Posted: 2025-02-21
Locations: Velocity Clin Res-Chula Vista, Chula Vista, California, 91911, United States|Headlands Research California, LLC, Escondido, California, 92025, United States|St. Jos Heritage Hlthcr_Fllrtn, Fullerton, California, 92835, United States|Velocity Clinical Research 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|Velocity Clin Res Wstlke, Los Angeles, California, 90057, United States|Valley Clinical Trials, Inc., Northridge, California, 91325, United States|Artemis Insitute for Clin Res, Riverside, California, 92503, United States|Artemis Institute for Clin Res, San Diego, California, 92103, United States|San Fernando Valley Hlth Inst, West Hills, California, 91304, United States|Northeast Research Institute, Jacksonville, Florida, 32204, United States|Reyes Clinical Research, Inc, Miami, Florida, 33175, United States|South Broward Research LLC, Miramar, Florida, 33027, United States|Progressive Medical Research, Port Orange, Florida, 32127, United States|Headlands Research - Sarasota, Sarasota, Florida, 34243, United States|Solaris Clinical Research, Meridian, Idaho, 83646, United States|Cedar-Crosse Research Center, Chicago, Illinois, 60607, United States|Iowa Diabetes & Endo Res Ctr, West Des Moines, Iowa, 50265, United States|The Research Group of Lexington LLC, Lexington, Kentucky, 40503, United States|Brigham & Women's Hospital, Boston, Massachusetts, 02115-5804, United States|Arcturus Healthcare, PLC, Troy, Michigan, 48098, United States|Mercury Str Med Grp, PLLC, Butte, Montana, 59701, United States|Albany Medical College - Endo, Albany, New York, 12203, United States|University of North Carolina, Chapel Hill, North Carolina, 27514, United States|PharmQuest Life Sciences LLC, Greensboro, North Carolina, 27408, United States|Physicians East Endocrinology, Greenville, North Carolina, 27834, United States|Piedmont Healthcare/Research, Statesville, North Carolina, 28625, United States|Advanced Med Res Maumee, Maumee, Ohio, 43537, United States|Essential Medical Research LLC, Tulsa, Oklahoma, 74137, United States|Spartanburg Medical Research, Spartanburg, South Carolina, 29303, United States|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States|UT Southwestern Med Cntr, Dallas, Texas, 75390-9302, United States|Quality Research Inc, San Antonio, Texas, 78209, United States|VIP Trials_San Antonio, San Antonio, Texas, 78230, United States|Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States|Medical centre "Zdrave 1" OOD, Kozloduy, 3320, Bulgaria|Individual Practice for medical care -Dr Elizabeta Dimitrova, Petrich, 2850, Bulgaria|UMHAT Aleksandrovska, Sofia, 1431, Bulgaria|Medical centre - Doverie AD, Sofia, 1632, Bulgaria|UMHAT Sofiamed, Sofia, 1797, Bulgaria|"Prevencia-2000-MCOC", Stara Zagora, 6000, Bulgaria|Medical center Berbatov, Yambol, 8600, Bulgaria|Aarhus Universitetshospital Diabetes og Hormonsygdomme, Aarhus N, 8200, Denmark|Center for Klinisk Metabolisk Forskning, Hellerup, 2900, Denmark|Hvidovre Hospital Endokrinologisk forsknings afsnit 159, Hvidovre, 2650, Denmark|University Hospital of Athens ATTIKON, Athens, Attica, 12462, Greece|Alexandra General Hospital, Therapeutic Clinic, Athens, 11528, Greece|Iatriko Athinon (Athens Medical Canter), Athens, 15125, Greece|Iatriko Athinon 'Palaiou Falirou', Athens, 17562, Greece|"Laiko" General Hospital of Athens, Athens, GR-11527, Greece|EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes, Thessaloniki, 54643, Greece|"Thermi" Private Hosital, Thessaloniki, 57001, Greece|PTE-AOK II. Belgyogyaszati Klinika es Nephrologiai Centrum, Pécs, Baranya Vármegye, 7623, Hungary|Debreceni Egyetem Belgyógyászati Klinika, Debrecen, Hajdu-Bihar, 4032, Hungary|Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft., Budapest, 1036, Hungary|Bajcsy-Zsilinszky Kórház, Budapest, 1106, Hungary|MED-TIMA Kft., Budapest, 1132, Hungary|MH Egészségügyi Központ, Budapest, 1134, Hungary|Békés Megyei Központi Kórház - dr. Réthy Pál Tagkórház, Békéscsaba, 5600, Hungary|Debreceni Egyetem Klinikai Központ Belgyógyászati Klinika D épület, Debrecen, 4043, Hungary|Békés Megyei Központi Kórház, Gyula, 5700, Hungary|Kaposi Mór Oktató Kórház, Kaposvár, 7400, Hungary|Markusovszky Egyetemi Oktatókórház, Szombathely, 9700, Hungary|Szent Borbála Kórház, Tatabánya, 2800, Hungary|Naka Kinen Clinic, Ibaraki, 311-0113, Japan|Yoshimura clinic, Kumamoto, 861-8039, Japan|Kansai Electric Power Hospital, Osaka, 553-0003, Japan|Tokyo Center Clinic, Tokyo, 103-0028, Japan|ToCROM Clinic, Tokyo, 160-0008, Japan|Higashi-shinjuku clinic, Tokyo, 169-0072, Japan|NZOZ Vita-Diabetica Malgorzata Buraczyk, Bialystok, Podlaskie Voivodeship, 15-879, Poland|Krakowskie Centrum Medyczne Sp. z o.o., Krakow, 31-501, Poland|Centrum Terapii Współczesnej J.M. Jasnorzewska S.K.A., Lodz, 90-338, Poland|FutureMeds Sp. z o.o. Lodz, Lodz, 91-363, Poland|Velocity Nova Sp. z o.o., Staszow, 28-200, Poland|Osrodek Badan Klinicznych Clinsante, Torun, 87-100, Poland|Centrum Medyczne AMED Warszawa, Warszawa, 00-215, Poland|Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji, Warszawa, 02-507, Poland|FutureMeds Sp. z o.o., Wroclaw, 50-088, Poland|SPSK nr 1 im. prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach, ul. 3-go Maja 13/15 41-800 Zabrze, Zabrze, 41-800, Poland|Tumen State Medical University, Tumen, Russia, 625023, Russian Federation|LLC RC Medical, Novosibirsk, 630005, Russian Federation|Penza Regional Clinical Hospital named after N.N. Burdenko, Penza, 440026, Russian Federation|Medinet LLC, Saint-Petersburg, 194356, Russian Federation|CHC Zvezdara, Clinical department for endocrinology, Belgrade, 11000, Serbia|Endocrinology, Diabetes and Metabolism Diseases Clinic, Belgrade, 11000, Serbia|Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department, Kragujevac, 34000, Serbia|Clinical Centre Kragujevac, Internal Diseases Clinic, Endocr, Kragujevac, 34000, Serbia
URL: https://clinicaltrials.gov/show/NCT05144984

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress