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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1313-6325 | Other Identifier | World Health Organization (WHO) | |
| 2024-520441-23 | Other Identifier | European Medical Agency (EMA) |
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The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and type 2 diabetes. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (treatment that has no active medicine in it). Which treatment participants get is decided by chance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0487-0111 dose level 1 | Experimental | Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
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| NNC0487-0111 dose level 2 | Experimental | Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
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| NNC0487-0111 dose level 3 | Experimental | Participants will be randomized to receive NNC0487-0111 dose level 3 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
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| NNC0487-0111 dose level 4 | Experimental | Participants will be randomized to receive NNC0487-0111 dose level 4 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
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| Placebo | Placebo Comparator | Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0487-0111 | Drug | NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Measured as percentage (%) of body weight. | From baseline (week 0) to (week 84) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in waist circumference | Measured as centimetre (cm). | From baseline (week 0) to (week 84) |
| Change in glycated haemoglobin (HbA1c) | Measured as percentage (%) of HbA1c. |
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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 |
|---|---|---|---|---|---|---|
| Univ of Alabama Birmingham | Recruiting | Birmingham | Alabama | 35294 | 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
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| Placebo (matched to NNC0487-0111) | Drug | Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
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| From baseline (week 0) to (week 84) |
| Change in systolic blood pressure (SBP) | Measured as millimetre of mercury (mmHg). | From baseline (week 0) to (week 84) |
| Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) physical function score | Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. The physical function score ranges from 0-100. Higher scores indicate better levels of functioning. | From baseline (week 0) to (week 84) |
| Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score | Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation (SD) of 10. The physical functioning ranges from 19.0 to 57.6. Higher scores indicate better functional health and well-being. | From baseline (week 0) to (week 84) |
| Change in body weight | Measured as kilogram (kg). | From baseline (week 0) to (week 84) |
| Change in body mass index (BMI) | Measured as kilograms per meter squared (kg/m^2). | From baseline (week 0) to (week 84) |
| Change in IWQOL-Lite-CT: Physical, Psychosocial, Total score | Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. The physical function score ranges from 0-100. Higher scores indicate better levels of functioning. | From baseline (week 0) to (week 84) |
| Achievement of HbA1c < 7.0% (Yes/No) | Measured as number of participants | From baseline (week 0) to (week 84) |
| Achievement of HbA1c ≤ 6.5% (Yes/No) | Measured as number of participants | From baseline (week 0) to (week 84) |
| Achievement of HbA1c < 5.7% (Yes/No) | Measured as number of participants | From baseline (week 0) to (week 84) |
| Change in fasting plasma glucose (FPG) (mmol/L) | Measured as millimoles per liter (mmol/L) | From baseline (week 0) to (week 84) |
| Change in fasting plasma glucose (FPG) (mg/dL) | Measured as milligram per deciliter (mg/dL) | From baseline (week 0) to (week 84) |
| Change in fasting insulin | Measured as ratio to baseline. | From baseline (week 0) to (week 84) |
| Change in urinary albumin-to-creatinine ratio (UACR) | Measured as ratio to baseline. | From baseline (week 0) to (week 84) |
| Change in diastolic blood pressure | Measured as mmHg. | From baseline (week 0) to (week 84) |
| Change in high-sensitivity C-reactive protein (hsCRP) | Measured as ratio to baseline. | From baseline (week 0) to (week 84) |
| Number of Treatment Emergent Adverse Events (TEAEs) | Measured as count of events. | From baseline (week 0) to week 88 |
| Number of Treatment Emergent Serious Adverse Events (TESAEs) | Measured as count of events. | From baseline (week 0) to week 88 |
| Number of Treatment Emergent Adverse Events (TEAEs) leading to permanent treatment discontinuation | Measured as count of events. | From baseline (week 0) to week 88 |
| Number of treatment emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL), confirmed by a blood glucose (BG) meter) | Measured as number of episodes | From baseline (week 0) to week 88 |
| Number of treatment emergent severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold | Measured as number of episodes | From baseline (week 0) to week 88 |
| Change in Total cholesterol | Measured as ratio to baseline. | From baseline (week 0) to (week 84) |
| Change in High-density lipoprotein (HDL) cholesterol | Measured as ratio to baseline. | From baseline (week 0) to (week 84) |
| Change in Low-density lipoprotein (LDL) cholesterol | Measured as ratio to baseline. | From baseline (week 0) to (week 84) |
| Change in Very low-density lipoprotein (VLDL) cholesterol | Measured as ratio to baseline. | From baseline (week 0) to (week 84) |
| Change in Non-HDL cholesterol | Measured as ratio to baseline. | From baseline (week 0) to (week 84) |
| Change in Triglycerides | Measured as ratio to baseline. | From baseline (week 0) to (week 84) |
| Headlands Research California, LLC |
| Recruiting |
| Escondido |
| California |
| 92025 |
| United States |
| Torrance Clinical Research Institute, Inc. | Recruiting | Lomita | California | 90717 | United States |
| Diablo Clinical Research, Inc. | Recruiting | Walnut Creek | California | 94598 | United States |
| Northeast Research Institute | Recruiting | Fleming Island | Florida | 32003 | United States |
| Jacksonville Ctr Clin Res | Recruiting | Jacksonville | Florida | 32216 | United States |
| Florida Institute for Clinical Research, LLC | Recruiting | Orlando | Florida | 32825 | United States |
| Oviedo Medical Research, LLC | Recruiting | Oviedo | Florida | 32765 | United States |
| International Diabetes Center | Recruiting | Minneapolis | Minnesota | 55416 | United States |
| Southgate Medical Group, LLP | Recruiting | West Seneca | New York | 14224 | United States |
| Spartanburg Medical Research | Recruiting | Spartanburg | South Carolina | 29303 | United States |
| M3 Wake Research Chattanooga | Recruiting | Chattanooga | Tennessee | 37421 | United States |
| UT Southwestern Med Center | Recruiting | Dallas | Texas | 75390 | United States |
| PlanIt Research, PLLC | Recruiting | Houston | Texas | 77079 | United States |
| National Clin Res Inc. | Recruiting | Richmond | Virginia | 23294 | United States |
| MICA- Medicina e Investigación Cardiometabólica | Recruiting | Manuel Alberti | Buenos Aires | B1669 | Argentina |
| Kynet Recoleta | Recruiting | Buenos Aires | C1119ACU | Argentina |
| Centro médico privado Cemaic | Recruiting | Córdoba | X5008 | Argentina |
| CEDIR - Centro de diagnóstico y rehabilitación Santa Fe | Recruiting | Santa Fe | S3000FSO | Argentina |
| Cline Research Center | Recruiting | Curitiba | Paraná | 80030-480 | Brazil |
| PUCCAMP - Hospital e Maternidade Celso Pierro | Recruiting | Campinas | São Paulo | 13060-803 | Brazil |
| CPCLIN - Centro de Pesquisas Clínicas | Recruiting | São Paulo | São Paulo | 01228-200 | Brazil |
| Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP | Recruiting | São Paulo | São Paulo | 05403-000 | Brazil |
| Opca bolnica Karlovac | Recruiting | Karlovac | 47000 | Croatia |
| Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology | Recruiting | Krapinske Toplice | 49217 | Croatia |
| Specijalna bolnica Thalassotherapia | Recruiting | Opatija | 51 410 | Croatia |
| Poliklinika SLAVONIJA OSIJEK | Recruiting | Osijek | 31000 | Croatia |
| Opca bolnica Pula | Recruiting | Pula | 52100 | Croatia |
| Poliklinika za oftalmologiju optometriju i neurologiju Lux | Recruiting | Solin | 21210 | 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 |
| DRC Kft. | Not yet recruiting | Balatonfüred | 8230 | Hungary |
| Szent Margit Rendelőintézet Nonprofit Kft. | Not yet recruiting | Budapest | 1032 | Hungary |
| Semmelweis Egyetem | Completed | Budapest | 1083 | Hungary |
| PVN Kutató Kft. | Not yet recruiting | Budapest | 1102 | Hungary |
| Észak-Pesti Centrumkórház Honvédkórház - Diabetológia Szakrendelés | Not yet recruiting | Budapest | 1134 | Hungary |
| Trantor 99 Bt | Not yet recruiting | Budapest | H-1213 | Hungary |
| Somogy Vármegyei Kaposi Mór Oktató Kórház | Not yet recruiting | Kaposvár | 7400 | Hungary |
| Dip. Med. Chir. delle malattie digestive, epatiche ed endo-meta - UOC Endocrinologia e prevenzione e cura del diabete | Recruiting | Bologna | Emilia-Romagna | 40138 | Italy |
| Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina Sperimentale | Recruiting | Rome | Lazio | 00161 | Italy |
| Grande Ospedale Metropolitano Niguarda - Dipartimento Medico Polispecialistico - Diabetologia | Recruiting | Milan | Lombardy | 20159 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - PSD Nutrizione Clinica, Obesità e Metabolismo | Recruiting | Palermo | Sicily | 90127 | Italy |
| IRCCS Ospedale San Raffaele Milano | Recruiting | Milan | 20132 | Italy |
| Dip. di Medicina Interna Policlinico Universitario Palermo | Not yet recruiting | Palermo | 90127 | Italy |
| Centro de Investigacion Clinica Endocrinologica de Jalisco | Not yet recruiting | Guadalajara | Jalisco | 44670 | Mexico |
| Clinstile S.A. de C.V. | Not yet recruiting | Col Roma Norte | Mexico City | 06700 | Mexico |
| Instituto Nacional de Nutricion - Unidad de Inv de Enf Metab | Not yet recruiting | Distrito Federal | México, D.F. | 14080 | Mexico |
| Unidad Medica para la Salud Integral (UMSI) | Not yet recruiting | San Nicolás de los Garza | Nuevo León | 66465 | Mexico |
| Centro de Investigación Clinica de Oaxaca (CICLO) | Not yet recruiting | Oaxaca City | Oaxaca | 68020 | Mexico |
| Consultorio de Endocrinología y Pediatría | Not yet recruiting | Puebla City | 72190 | Mexico |
| S.C. Top Diabet Srl | Recruiting | Craiova | Dolj | 200515 | Romania |
| Poli Cardinal Med Srl | Recruiting | Reghin | Mureș County | 545300 | Romania |
| CMI Dr. Pletea Noemi SRL | Recruiting | Bacau | 600154 | Romania |
| SC Nutrilife SRL | Recruiting | Bucharest | 013764 | Romania |
| SC Clinica Diabnutrimed S.R.L. | Recruiting | Bucharest | 020359 | Romania |
| Diabet Med SRL | Recruiting | Bucharest | 050913 | Romania |
| Cmi Dr. Cojocaru Cristina | Recruiting | Constanța | 900512 | Romania |
| A&C Medical Prime S.R.L. | Not yet recruiting | Craiova | 200692 | Romania |
| Spital Judetean De Urgenta Satu Mare | Recruiting | Satu Mare | 440055 | Romania |
| DIA - KONTROL s.r.o. | Recruiting | Levice | 93401 | Slovakia |
| Narodny Endokrinologicky a diabetologicky ustav | Recruiting | Ľubochňa | 03491 | Slovakia |
| OLIVER - MED s.r.o. | Recruiting | Rimavská Sobota | 979 01 | Slovakia |
| Peter Farkas MD, s.r.o. | Recruiting | Šahy | 93601 | Slovakia |
| DEImedi, s. r. o. | Recruiting | Šurany | 942 01 | Slovakia |
| ARETEUS s.r.o. | Recruiting | Trebišov | 075 01 | Slovakia |
| ARETEUS s.r.o. | Not yet recruiting | Trebišov | 075 01 | Slovakia |
| Seoul National University Bundang Hospital_Endocrinology | Recruiting | Seoungnam-si | Gyeonggi-do | 13620 | South Korea |
| Chonnam National University Hospital_Endocrinology | Recruiting | Gwangju | 61469 | South Korea |
| Kyunghee University Medical Center_Endocrinology | Recruiting | Seoul | 02447 | South Korea |
| Seoul National University Hospital_Endocrinology | Recruiting | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System_Endocrinology | Recruiting | Seoul | 03722 | South Korea |
| Asan Medical Center_Endocrinology | Recruiting | Seoul | 05505 | South Korea |
| The Catholic University of Korea, Yeouido ST. Mary's Hospital_Endocrinology | Recruiting | Seoul | 07345 | South Korea |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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