A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes
NCT Number: NCT06542874
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Type 2 Diabetes (T2D)
Interventions: DRUG: NNC0487-0111 subcutanous|DRUG: Placebo (NNC0487-0111 subcutanous)|DRUG: NNC0487-0111 oral|DRUG: Placebo (NNC0487-0111 oral)
Sponsor: Novo Nordisk A/S
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 432
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-07
Completion Date: 2025-10-24
Locations: Southern Cal Clinical Research, Santa Ana, California, 92701, United States|Southern California Dermatology, Santa Ana, California, 92701, United States|Chase Medical Research LLC, Waterbury, Connecticut, 06708, United States|Chase Medical Research LLC, Waterbury, Connecticut, 06708, United States|Fleming Island Ctr for Clin Res, Fleming Island, Florida, 32003, United States|Fleming Island Ctr for Clin Res, Fleming Island, Florida, 32003, United States|South Broward Research LLC, Miramar, Florida, 33027, United States|South Broward Research LLC, Miramar, Florida, 33027, United States|Florida Inst For Clin Res, Orlando, Florida, 32825, United States|Florida Inst For Clin Res, Orlando, Florida, 32825, United States|Advanced Internal Medicine, PLLC, Paducah, Kentucky, 42001, United States|Advanced Internal Medicine, PLLC, Paducah, Kentucky, 42001, United States|Medstar Research Institute_Hyattsville, Hyattsville, Maryland, 20782, United States|Medstar Research Institute_Hyattsville, Hyattsville, Maryland, 20782, United States|MD Medical Research, Oxon Hill, Maryland, 20745, United States|MD Medical Research, Oxon Hill, Maryland, 20745, United States|Arcturus Healthcare, PLC, Troy, Michigan, 48098, United States|Arcturus Healthcare, PLC, Troy, Michigan, 48098, United States|Clinical Research Professionals, Chesterfield, Missouri, 63005, United States|Clinical Research Professionals, Chesterfield, Missouri, 63005, United States|Piedmont Healthcare/Research, Statesville, North Carolina, 28625, United States|Piedmont Healthcare/Research, Statesville, North Carolina, 28625, United States|Plains Clinical Research Center, LLC_Fargo, Fargo, North Dakota, 58104, United States|Plains Clinical Research Center, LLC_Fargo, Fargo, North Dakota, 58104, United States|Preferred Primary Care Physicians_Pittsburgh, Pittsburgh, Pennsylvania, 15236, United States|Preferred Primary Care Physicians_Pittsburgh, Pittsburgh, Pennsylvania, 15236, United States|Health Concepts, Rapid City, South Dakota, 57702, United States|Health Concepts, Rapid City, South Dakota, 57702, United States|MidState Endocrine Associates, Nashville, Tennessee, 37203, United States|MidState Endocrine Associates, Nashville, Tennessee, 37203, United States|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States|Synergy Groups Medical, Houston, Texas, 77061, United States|Synergy Groups Medical, Houston, Texas, 77061, United States|PlanIt Research, PLLC, Houston, Texas, 77079, United States|PlanIt Research, PLLC, Houston, Texas, 77079, United States|Tekton Research, McKinney, Texas, 75069, United States|Tekton Research, McKinney, Texas, 75069, United States|Hillcrest Family Health Center, Waco, Texas, 76708, United States|Hillcrest Family Health Center, Waco, Texas, 76708, United States|Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd., Kyustendil, 2500, Bulgaria|Individual Practice For Specialized Outpatient Medical Care Doctor Miglena Rizova Ltd., Kyustendil, 2500, Bulgaria|UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases, Plovdiv, 4001, Bulgaria|UMHAT "Kaspela", Depart. Endocrinology and Metab. Diseases, Plovdiv, 4001, Bulgaria|Diagnostic-Consultative Centre "Sveti Georgi" Eood, Plovdiv, 4002, Bulgaria|Diagnostic-Consultative Centre "Sveti Georgi" Eood, Plovdiv, 4002, Bulgaria|Medical centre Regina Life Clinic EOOD, Sofia, 1000, Bulgaria|Medical centre Regina Life Clinic EOOD, Sofia, 1000, Bulgaria|UMHAT "Aleksandrovska", Sofia, 1431, Bulgaria|UMHAT "Aleksandrovska", Sofia, 1431, Bulgaria|USHATE "Akad. Ivan Penchev" Second Clinic of Endocrinology, Sofia, 1431, Bulgaria|AIPSMC Dr. Artin Magardichyan EOOD, Varna, 9020, Bulgaria|AIPSMC Dr. Artin Magardichyan EOOD, Varna, 9020, Bulgaria|Poliklinika Solmed, Zagreb, Grad Zagreb, 10000, Croatia|Poliklinika Solmed, Zagreb, Grad Zagreb, 10000, Croatia|KBC Rijeka, Endokrinologija, Rijeka, Primorsko - Goranska Županija, 51 000, Croatia|KBC Rijeka, Endokrinologija, Rijeka, Primorsko - Goranska Županija, 51 000, Croatia|Opca bolnica Karlovac, Karlovac, 47000, Croatia|Opca bolnica Karlovac, Karlovac, 47000, Croatia|Specijalna bolnica Krapinske Toplice - Endokrinologija, Krapinske Toplice, 49217, Croatia|Specijalna bolnica Krapinske Toplice - Endokrinologija, Krapinske Toplice, 49217, Croatia|Klinicki bolnicki centar Osijek, Osijek, 31 000, Croatia|Klinicki bolnicki centar Osijek, Osijek, 31 000, Croatia|Opca bolnica Varazdin, Varazdin, 42 000, Croatia|Opca bolnica Varazdin, Varazdin, 42 000, Croatia|Zentrum fuer klinische Studien Suedbrandenburg GmbH, Elsterwerda, 04910, Germany|Zentrum fuer klinische Studien Suedbrandenburg GmbH, Elsterwerda, 04910, Germany|InnoDiab Forschung GmbH, Essen, 45136, Germany|InnoDiab Forschung GmbH, Essen, 45136, Germany|Wendisch/Dahl Hamburg, Hamburg, 22607, Germany|Wendisch/Dahl Hamburg, Hamburg, 22607, Germany|Institut für Diabetesforschung GmbH Münster - Dr. med. Rose, Münster, 48145, Germany|Institut für Diabetesforschung GmbH Münster - Dr. med. Rose, Münster, 48145, Germany|RED-Institut für medizinische Forschung und Fortbildung GmbH, Oldenburg in Holstein, 23758, Germany|RED-Institut für medizinische Forschung und Fortbildung GmbH, Oldenburg in Holstein, 23758, Germany|Iatriko Psychicou Private Clinic, Athens, 115 25, Greece|Iatriko Psychicou Private Clinic, Athens, 115 25, Greece|U.G.H of Athens "Attikon", Athens, 12462, Greece|"Laiko" General Hospital of Athens, Goudi/Athens, 11527, Greece|424 Military General Training Hospital, Thessaloniki, 564 29, Greece|EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes, Thessaloniki, GR-54643, Greece|EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes, Thessaloniki, GR-54643, Greece|"Thermi" Private Hosital, Thessaloniki, GR-57001, Greece|"Thermi" Private Hosital, Thessaloniki, GR-57001, Greece|Bajcsy-Zsilinszky Kórház, Budapest, 1106, Hungary|MH Egészségügyi Központ, Budapest, 1134, Hungary|Debreceni Egyetem, Debrecen, H-4031, Hungary|Debreceni Egyetem, Debrecen, H-4031, Hungary|Debreceni Egyetem, Debrecen, H-4032, Hungary|Debreceni Egyetem, Debrecen, H-4032, Hungary|Békés Megyei Központi Kórház, Gyula, 5700, Hungary|Somogy Vármegyei Kaposi Mór Oktató Kórház, Kaposvár, H-7400, Hungary|Somogy Vármegyei Kaposi Mór Oktató Kórház, Kaposvár, H-7400, Hungary|Heiwadai Hospital, Miyazaki-shi, Miyazaki, 880-0034, Japan|Heiwadai Hospital, Miyazaki-shi, Miyazaki, 880-0034, Japan|TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology, Aichi, 468-0009, Japan|TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology, Aichi, 468-0009, Japan|Akaicho Clinic, Chiba-shi, Chiba, 260-0804, Japan|Akaicho Clinic, Chiba-shi, Chiba, 260-0804, Japan|Tokuyama clinic, Chiba, 261-0004, Japan|Tokuyama clinic, Chiba, 261-0004, Japan|Naka Kinen Clinic, Ibaraki, 311-0113, Japan|Naka Kinen Clinic, Ibaraki, 311-0113, Japan|Tokyo-Eki Center-building Clinic, Tokyo, 103-0027, Japan|Tokyo-Eki Center-building Clinic, Tokyo, 103-0027, Japan|Fukuwa Clinic, Tokyo, 104-0031, Japan|Fukuwa Clinic, Tokyo, 104-0031, Japan|Beata Mikłaszewicz & Dariusz Dąbrowski "CARDIAMED" s.j., Legnica, Dolnośląskie, 59-220, Poland|Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET, Krakow, Malopolskie, 31-261, Poland|Formed 2 Sp. z o.o., Oswiecim, Malopolskie, 32-600, Poland|Formed 2 Sp. z o.o., Oswiecim, Malopolskie, 32-600, Poland|ETG Siedlce, Siedlce, Masovian, 08-110, Poland|ETG Siedlce, Siedlce, Masovian, 08-110, Poland|NZOZ Vita-Diabetica Malgorzata Buraczyk, Bialystok, Podlaskie Voivodeship, 15-879, Poland|NZOZ Vita-Diabetica Malgorzata Buraczyk, Bialystok, Podlaskie Voivodeship, 15-879, Poland|Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia, Lodz, Wojewodztwo Lodzkie, 90-302, Poland|Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia, Lodz, Wojewodztwo Lodzkie, 90-302, Poland|Specderm Poznańska Spółka Jawna, Bialystok, 15-375, Poland|Specderm Poznańska Spółka Jawna, Bialystok, 15-375, Poland|EKAMED sp. z o.o., Lublin, 20-718, Poland|EKAMED sp. z o.o., Lublin, 20-718, Poland|Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j., Ruda Slaska, 41-709, Poland|Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j., Ruda Slaska, 41-709, Poland|PANSTWOWY INSTYTUT MEDYCZNY MSWiA, Warszawa, 02-507, Poland|PANSTWOWY INSTYTUT MEDYCZNY MSWiA, Warszawa, 02-507, Poland|SC Grand Med SRL, Oradea, Bihor, 410025, Romania|SC Grand Med SRL, Oradea, Bihor, 410025, Romania|Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila, Bucharest, Bucurestii, 020475, Romania|Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila, Bucharest, Bucurestii, 020475, Romania|Spitalul Clinic Judetean Urgenta Cluj-Napoca, Cluj Napoca, Cluj, 400006, Romania|Sc Mediab Srl, Tirgu Mures, Mures, 540142, Romania|Sc Mediab Srl, Tirgu Mures, Mures, 540142, Romania|Novus Medical Clinica SRL, Ploiesti, Prahova, 100018, Romania|Novus Medical Clinica SRL, Ploiesti, Prahova, 100018, Romania|Mariodiab Clinic SRL, Brasov, 500101, Romania|Mariodiab Clinic SRL, Brasov, 500101, Romania|Cabinet Medical Dr Geru SRL, Timisoara, 300288, Romania|Cabinet Medical Dr Geru SRL, Timisoara, 300288, Romania|Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara, Timisoara, 300723, Romania|Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara, Timisoara, 300723, Romania|Peter Farkas MD, s.r.o., Sahy, Slovak Republic, 93601, Slovakia|Peter Farkas MD, s.r.o., Sahy, Slovak Republic, 93601, Slovakia|DENTAVIA s.r.o., Poprad, 05801, Slovakia|DENTAVIA s.r.o., Poprad, 05801, Slovakia|DIABETOL, s.r.o., Presov, 080 01, Slovakia|DIABETOL, s.r.o., Presov, 080 01, Slovakia|OLIVER - MED s.r.o., Rimavska Sobota, 979 01, Slovakia|OLIVER - MED s.r.o., Rimavska Sobota, 979 01, Slovakia|MEDIVASA, s.r.o., Diabetologicka ambulancia, Zilina, 010 01, Slovakia|MEDIVASA, s.r.o., Diabetologicka ambulancia, Zilina, 010 01, Slovakia|Hospital Clinic i Provincial, Barcelona, 08036, Spain|Hospital Clinic i Provincial, Barcelona, 08036, Spain|Hospital Vithas Sevilla, Castilleja Dela Cuesta Sevilla, 41950, Spain|Complejo Hospitalario Universitario A Coruña, La Coruña, 15006, Spain|Complejo Hospitalario Universitario A Coruña, La Coruña, 15006, Spain|Hospital Gregorio Marañón, Madrid, 28007, Spain|Hospital Gregorio Marañón, Madrid, 28007, Spain|Hospital Universitario Marqués de Valdecilla, Santander, 39008, Spain|Hospital Universitario Marqués de Valdecilla, Santander, 39008, Spain|Clínica Nuevas Tecnologías en Diabetes y Endocrinología, Sevilla, 41003, Spain|Clínica Nuevas Tecnologías en Diabetes y Endocrinología, Sevilla, 41003, Spain|Hospital Infanta Luisa, Sevilla, 41010, Spain|Hospital Nisa Sevilla Aljarafe, Sevilla, 41950, Spain

Summary:
The study will look at how well different doses of a new medicine called NNC0487-0111 help lower the blood sugar and body weight in people with type 2 diabetes. NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Participants will either get NNC0487-0111, which is given as tablets or as injections, or placebo. Which treatment the participant get is decided by chance.The study will last for about 43 weeks.

Primary Outcome Measures: Change in HbA1c, percent point, From baseline (week 0) to end of treatment (week 36)
Secondary Outcome Measures: Relative change in body weight, percent, From baseline (week 0) to end of treatment (week 36)|Change in body weight, kg, From baseline (week 0) to end of treatment (week 36)|Change in fasting plasma glucose (FPG), mmol/L, From baseline (week 0) to end of treatment (week 36)|CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL), percent points, From baseline (week 0) to end of treatment (week 36)|Change in body mass index (BMI), kg/m\^2, From baseline (week 0) to end of treatment (week 36)|Change in waist circumference, cm, From baseline (week 0) to end of treatment (week 36)|Change in systolic blood pressure (SBP), mmHg, From baseline (week 0) to end of treatment (week 36)|Change in average 24-hour systolic blood pressure (SBP), mmHg, From baseline (week 0) to end of treatment (week 36)|Change in high sensitivity C-Reactive Protein (hsCRP), Ratio to baseline, From baseline (week 0) to end of treatment (week 36)|Change in total cholesterol, Ratio to baseline, From baseline (week 0) to end of treatment (week 36)|Change in high-density lipoprotein (HDL) cholesterol, Ratio to baseline, From baseline (week 0) to end of treatment (week 36)|Change in low-density lipoprotein (LDL) cholesterol, Ratio to baseline, From baseline (week 0) to end of treatment (week 36)|Change in triglycerides, Ratio to baseline, From baseline (week 0) to end of treatment (week 36)|Number of adverse events, Count of events, From baseline (week 0) to end of study (week 40)|Change in Urinary Albumin/Creatinine Ratio (UACR), Ratio to baseline, From baseline (week 0) to end of treatment (week 36)|Participant without macroalbuminuria (UACR < 300 mg/g) at baseline (week 0) developing (yes/no) new onset of macroalbuminuria (UACR ≥ 300 mg/g), Count of participant, At end of treatment (week 36)|Change in eGFR creatinine-cystatin C based CKD-EPI, mL/min/1.73 m\^2, From baseline (week 0) to end of treatment (week 36)