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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1324-0310 | Other Identifier | World Health Organization (WHO) | |
| 2025-523260-20 | Other Identifier | European Medical Agency (EMA) |
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This study is being done to look at the effect and safety of different doses of NNC0662-0419 in people living with type 2 diabetes when compared to placebo or semaglutide. The purpose of this clinical study is to find out if NNC0662-0419 is effective and safe for treating people living with type 2 diabetes. Participants will get either NNC0662-0419, semaglutide or placebo. Which treatment participants get is decided by chance. NNC0662-0419 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Semaglutide is an approved medication to treat type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0662-0419 | Experimental | Participants will receive NNC0662-0419 subcutaneously (s.c.) in a dose escalating manner once weekly. |
|
| Semaglutide | Active Comparator | Participants will receive semaglutide s.c. once weekly. |
|
| Placebo | Placebo Comparator | Participants will receive placebo matched to their respective investigational medicinal product s.c. once weekly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0662-0419 | Drug | NNC0662-0419 will be administered subcutaneously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) (week 16) | Measured as percentage-point (%-point). | From baseline (week 0) to week 16 |
| Change in HbA1c (week 28) | Measured as %-point. | From baseline (week 0) to week 28 |
| Change in HbA1c (week 40) | Measured as %-point. | From baseline (week 0) to week 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Measured as percentage (%). | From baseline (week 0) to (week 40) |
| Change in body weight | Measured as kilogram (kg). |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Valley Medical Group | Recruiting | Lancaster | California | 93534 | United States | |
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.
| Semaglutide |
| Drug |
Semaglutide will be administered subcutaneously. |
|
| Placebo | Drug | Placebo will be administered subcutaneously. |
|
| From baseline (week 0) to (week 40) |
| Change in HbA1c | Measured as %-point. | From baseline (week 0) to (week 16, 28 and 40) |
| Change in Fasting Plasma Glucose (FPG) | Measured as millimoles per litre (mmol/L). | From baseline (week 0) to (week 16, 28 and 40) |
| Change in Body Mass Index (BMI) | Measured in kilograms per square metre (kg/m^2). | From baseline (week 0) to (week 40) |
| Change in waist circumference | Measured in centimetre (cm). | From baseline (week 0) to (week 40) |
| Change in high sensitivity C-Reactive Protein (hsCRP) | Measured as ratio to baseline. | From baseline (week 0) to (week 40) |
| Change in total cholesterol | Measured as ratio to baseline. | From baseline (week 0) to (week 40) |
| Change in High-Density Lipoprotein (HDL) cholesterol | Measured as ratio to baseline. | From baseline (week 0) to (week 40) |
| Change in Low-Density Lipoprotein (LDL) cholesterol | Measured as ratio to baseline. | From baseline (week 0) to (week 40) |
| Change in triglycerides | Measured as ratio to baseline. | From baseline (week 0) to (week 40) |
| Change in Urine Albumin Creatinine Ratio (UACR) | Measured as ratio to baseline. | From baseline (week 0) to (week 16, 28 and 40) |
| Change in estimated Glomerular Filtration Rate (eGFR) (creatinine cystatin C-based Chronic Kidney Disease-Epidemiology Collaboration [CKD-EPI] 2021) | Measured in millilitres per minute per 1.73 square metre (mL/min/1.73 m^2). | From baseline (week 0) to (week 40) |
| Number of adverse events | Measured as number of events. | From baseline (week 0) to (week 48) |
| Torrance Clinical Research Institute, Inc. |
| Recruiting |
| Lomita |
| California |
| 90717 |
| United States |
| Ark Clinical Research | Recruiting | Long Beach | California | 90815 | United States |
| Pacific Clinical Studies | Recruiting | Los Alamitos | California | 90720 | United States |
| Wetlin Research Associates, Inc. | Recruiting | San Diego | California | 92120 | United States |
| Diablo Clinical Research, Inc. | Recruiting | Walnut Creek | California | 94598 | United States |
| Encore Medical Research LLC | Recruiting | Hollywood | Florida | 33024 | United States |
| Bioclinical Research Alliance | Recruiting | Miami | Florida | 33155 | United States |
| South Broward Research LLC | Recruiting | Miramar | Florida | 33027 | United States |
| West Orange Endocrinology | Not yet recruiting | Ocoee | Florida | 34761 | United States |
| Encore Medical Research of Weston | Recruiting | Weston | Florida | 33331 | United States |
| Elite Clinical Trials | Recruiting | Blackfoot | Idaho | 83221 | United States |
| Cedar-Crosse Research Center | Recruiting | Chicago | Illinois | 60607 | United States |
| Brigham & Women's Hospital | Not yet recruiting | Boston | Massachusetts | 02115-5804 | United States |
| Headlands Research | Recruiting | Springfield | Missouri | 65807 | United States |
| PharmQuest | Recruiting | Greensboro | North Carolina | 27408 | United States |
| Piedmont Healthcare Statesville | Recruiting | Statesville | North Carolina | 28625 | United States |
| Providence Center for Clinical Research | Recruiting | Dayton | Ohio | 45439 | United States |
| CNS Healthcare | Recruiting | Memphis | Tennessee | 38119 | United States |
| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390-9302 | United States |
| JCCT- Juno NW Houston | Recruiting | Houston | Texas | 77040 | United States |
| Consano Clinical Research, LLC | Recruiting | Shavano Park | Texas | 78231 | United States |
| Frontier Clinical Research - Kingwood | Not yet recruiting | Kingwood | West Virginia | 26537 | United States |
| Opca bolnica Karlovac | Recruiting | Karlovac | 47000 | Croatia |
| Poliklinika SLAVONIJA OSIJEK | Recruiting | Osijek | 31000 | Croatia |
| Opca bolnica Varazdin_Endocrinology | Recruiting | Varaždin | 42 000 | Croatia |
| Poliklinika Solmed | Recruiting | Zagreb | 10000 | Croatia |
| Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ | Not yet recruiting | Szeged | Csongrád-Csanád | 6725 | Hungary |
| Debreceni Egyetem | Not yet recruiting | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| Debreceni Egyetem | Not yet recruiting | Debrecen | 4031 | Hungary |
| Akaicho Clinic_Internal medicine | Recruiting | Chiba-shi, Chiba | 260-0804 | Japan |
| Naka Kinen Clinic_Internal medicine | Recruiting | Ibaraki | 311-0113 | Japan |
| Soka Sugiura Internal Medicine Clinic | Recruiting | Soka-shi, Saitama | 340-0015 | Japan |
| Tokyo-Eki Center-building Clinic_Internal Medicine | Recruiting | Tokyo | 103-0027 | Japan |
| ToCROM Clinic_Internal Medicine | Recruiting | Tokyo | 160-0008 | Japan |
| "Zdrowie Osteo-Medic" s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik | Not yet recruiting | Bialystok | Podlaskie Voivodeship | 15-351 | Poland |
| Terpa Sp. z o.o. Sp. k. | Not yet recruiting | Lublin | 20-333 | Poland |
| Formed 2 Sp. z o.o. | Recruiting | Oświęcim | 32-600 | Poland |
| PANSTWOWY INSTYTUT MEDYCZNY MSWiA | Recruiting | Warsaw | 02-507 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko | Recruiting | Zabrze | 41-800 | Poland |
| Casa De Saúde De Santa Filomena S.A._Unidade de Ensaios Clínicos | Recruiting | Coimbra | 3000-150 | Portugal |
| Cardiolima Centro Diagnostico Cardio-Pulmonar De Ponte De Lima Lda | Recruiting | Ponte de Lima | 4990-029 | Portugal |
| Hospital Trofa Saude Senhor do Bonfim S.A_Unidade de Ensaios Clínicos | Recruiting | Vila do Conde | 4480-565 | Portugal |
| Hospital da Luz Arrábida, S.A_Serviço de Endocrinologia | Recruiting | Vila Nova de Gaia | 4400-346 | Portugal |
| DIADA, s.r.o. | Recruiting | Bardejov | 08501 | Slovakia |
| Metabol KLINIK s.r.o. | Recruiting | Bratislava | 811 08 | Slovakia |
| Diacrin s. r. o. | Recruiting | Bratislava | 83101 | Slovakia |
| SIN AZUCAR s.r.o. | Recruiting | Malacky | 901 01 | Slovakia |
| Korea University Ansan Hospital_Endocrinology | Not yet recruiting | Ansan-si | Gyeonggi-do | 15355 | South Korea |
| Pusan National University Yangsan Hospital | Not yet recruiting | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
| Nowon Eulji Medical Center, Eulji University_Endocrinology | Not yet recruiting | Seoul | 01830 | South Korea |
| Kangbuk Samsung Hospital_Endocrinology | Not yet recruiting | Seoul | 03181 | South Korea |
| ABS La Roca CAP Vicenç_Endocrino | Recruiting | La Roca Del Vallés | Barcelona | 08430 | Spain |
| Centro de Salud A Estrada | Not yet recruiting | A Estrada | 36680 | Spain |
| Equip D´Atencio Primaria Barcelona Sardenya | Recruiting | Barcelona | 08025 | Spain |
| Hospital Vithas Sevilla | Recruiting | Castilleja de la Cuesta | 41950 | Spain |
| Clínica Bofill | Recruiting | Girona | 17002 | Spain |
| Centro de Saúde Concepción Arenal | Not yet recruiting | Santiago de Compostela | 15701 | Spain |
| Ramathibodi Hospital | Recruiting | Bangkok | 10400 | Thailand |
| Siriraj Hospital | Recruiting | Bangkok | 10700 | Thailand |
| Maharaj Nakorn Chiang Mai | Not yet recruiting | Chiang Mai | 50200 | Thailand |
| Srinagarind Hospital | Not yet recruiting | Khon Kaen | 40002 | Thailand |
| Maharat Nakhon Ratchasima Hospital | Recruiting | Nakhon Ratchasima | 30000 | Thailand |
| 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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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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