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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1313-6538 | Other Identifier | World Health Organization (WHO) | |
| 2024-520443-16 | Other Identifier | European Medical Agency (EMA) |
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This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure. 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 (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0487-0111 | Experimental | Participants will be randomized to receive 1 of the 2 dose levels of NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Measured as percentage (%) change in body weight. | From baseline (week 0) to (week 80) |
| Change in apnoea-hypopnoea index (AHI) | Measured as events/hour. | From baseline (week 0) to (week 80) |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in AHI | Measured as percentage change in AHI. | From baseline (week 0) to (week 80) |
| Achievement of 50% reduction in AHI (Yes/No) | Measured as number of participant. |
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Key Inclusion Criteria:
Key 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 |
|---|---|---|---|---|---|---|
| Dignity Health, Mercy Gilbert | Recruiting | Gilbert | Arizona | 85297 | 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.
| 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. |
|
| From baseline (week 0) to (week 80) |
| Achievement of: AHI less than (<) 5 | Measured as number of participants. | From baseline (week 0) to (week 80) |
| Achievement of: AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No) | Measured as number of participants. | From baseline (week 0) to (week 80) |
| Change in sleep apnoea specific hypoxic burden (SASHB) | measured as %min/h (percentage minutes per hour). | From baseline (week 0) to (week 80) |
| Change in ESS score | Measured as score on a scale. ESS measures the level of daytime sleepiness or average sleep propensity. The measure consists of 8 items yielding one total score. Total score ranges from 0-24. Higher scores indicate higher sleepiness or average sleep propensity in daily life. | From baseline (week 0) to (week 80) |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-Related Impairment 8a score | Measured as score on a scale. PROMIS-SRI measures perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakeful-ness associated with sleep problems or impaired alertness. The measure consists of 8 items each rated on a 5-point scale ranging from "not at all" to "very much". Individual item scores will be combined and converted to a T-score using a response pattern scoring approach. The T-score standardises the raw score to a distribution with a mean of 50 and standard deviation of 10. Total score (T-score range): Sleep-related impairment (ranging approximately from 30-80.1). Higher scores indicate more sleep-related impairment. | From baseline (week 0) to (week 80) |
| Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score | Measured as score on a scale. PROMIS-SD measures perceptions of sleep quality, sleep depth, and restoration associated with sleep. The measure consists of 8 items each rated on a 5-point scale ranging from "not at all" to "very much," "never" to "always," or "very poor" to "very good". Individual item scores will be combined and converted to a T-score using a response pattern scoring approach. The T-score standardises the raw score to a distribution with a mean of 50 and standard deviation of 10. Total score (T-score range): Sleep disturbance (ranging approximately from 30-80.1). Higher scores indicate more sleep disturbance. | From baseline (week 0) to (week 80) |
| Change in body weight | Measured as kilogram (Kg). | From baseline (week 0) to (week 80) |
| Change in body mass index (BMI) | Measured as kilograms per meter square (kg/m^2). | From baseline (week 0) to (week 80) |
| Improvement in obstructive sleep apnoea (OSA) severity category: AHI < 5/hour = normal (Yes/No) | Measured as number of participants. | From baseline (week 0) to (week 80) |
| Improvement in OSA severity category: ≥ 5 and < 15/hour = mild (Yes/No) | Measured as number of participants. | From baseline (week 0) to (week 80) |
| Improvement in OSA severity category: ≥ 15 and < 30/hour = moderate (Yes/No) | Measured as number of participants. | From baseline (week 0) to (week 80) |
| Improvement in OSA severity category: ≥ 30/hour = severe (Yes/No) | Measured as number of participants. | From baseline (week 0) to (week 80) |
| Withdrawal of positive airway pressure (PAP) therapy (Yes/No) | Measured as number of participants. | From baseline (week 0) to (week 80) |
| Change in waist circumference | Measured as centimetre (cm). | From baseline (week 0) to (week 80) |
| Change in neck circumference | Measured as cm. | From baseline (week 0) to (week 80) |
| Change in systolic blood pressure (SBP) | Measured as millimetre of mercury (mmHg). | From baseline (week 0) to (week 80) |
| Change in diastolic blood pressure (DBP) | Measured as mmHg. | From baseline (week 0) to (week 80) |
| Change in high-sensitivity C-reactive protein (hsCRP) | Measured as ratio to baseline. | From baseline (week 0) to (week 80) |
| Change in Total cholesterol | Measured as ratio to baseline. | From baseline (week 0) to (week 80) |
| Change in High-density lipoprotein (HDL) cholesterol | Measured as ratio to baseline. | From baseline (week 0) to (week 80) |
| Change in Low-density lipoprotein (LDL) cholesterol | Measured as ratio to baseline. | From baseline (week 0) to (week 80) |
| Change in Very low-density lipoprotein (VLDL) cholesterol | Measured as ratio to baseline. | From baseline (week 0) to (week 80) |
| Change in Non-HDL cholesterol | Measured as ratio to baseline. | From baseline (week 0) to (week 80) |
| Change in Triglycerides | Measured as ratio to baseline. | From baseline (week 0) to (week 80) |
| Change in fasting plasma glucose | Measured as millimoles per litre (mmol/L). | From baseline (week 0) to (week 80) |
| Change in glycated haemoglobin (HbA1c) | Measured as percentage (%) of HbA1c. | From baseline (week 0) to (week 80) |
| Number of Treatment emergent adverse events (TEAEs) | Measured as events. | From baseline (week 0) to week 84 |
| Number of Treatment emergent serious adverse events (TESAEs) | Measured as Events. | From baseline (week 0) to week 84 |
| Number of TEAEs leading to permanent treatment discontinuation | Measured as events. | From baseline (week 0) to week 84 |
| DM Clinical |
| Recruiting |
| Bradenton |
| Florida |
| 34209 |
| United States |
| Essence MD Research | Recruiting | Naples | Florida | 34102 | United States |
| Palm Beach Research Center | Recruiting | West Palm Beach | Florida | 33409 | United States |
| NeuroTrials Research, Inc. | Recruiting | Atlanta | Georgia | 30328 | United States |
| Physicians Research Associates | Recruiting | Lawrenceville | Georgia | 30046 | United States |
| Chicago Research Center, Inc | Recruiting | Chicago | Illinois | 60634 | United States |
| Weil Cornell Medicine | Recruiting | New York | New York | 10021 | United States |
| Lillestol Research LLC | Recruiting | Fargo | North Dakota | 58104 | United States |
| CTI Clinical Research Center | Recruiting | Cincinnati | Ohio | 45212 | United States |
| Clinical Research Associates of Central PA, LLC | Not yet recruiting | DuBois | Pennsylvania | 15801 | United States |
| Bogan Sleep Consultants, LLC | Recruiting | Columbia | South Carolina | 29201 | United States |
| Epic Medical Research | Recruiting | DeSoto | Texas | 75115 | United States |
| Advanced Neurology Epilepsy and Sleep Center ANESC | Recruiting | El Paso | Texas | 79912 | United States |
| Biorhythms Center for Integrative Sleep Medicine | Recruiting | El Paso | Texas | 79912 | United States |
| Houston Pulmonary Medicine Associates, PA and Research Physicians Network, LLC | Recruiting | Houston | Texas | 77089 | United States |
| Sleep Therapy Research Center | Recruiting | San Antonio | Texas | 78229 | United States |
| Tricoastal Sleep Center | Recruiting | Sugar Land | Texas | 77478 | United States |
| Rainier Clin Res Ctr Inc | Recruiting | Renton | Washington | 98057 | United States |
| Seattle Clinical Research Center | Recruiting | Seattle | Washington | 98104 | United States |
| Woolcock Institute | Recruiting | Macquarie Park | New South Wales | 2113 | Australia |
| University of Sunshine Coast - Vitality Village | Recruiting | Birtinya | Queensland | 4575 | Australia |
| Mater Research - RIO Clinical Trials Unit | Not yet recruiting | South Brisbane | Queensland | 4101 | Australia |
| Nightingale Research | Recruiting | Adelaide | South Australia | 5000 | Australia |
| University of Western Australia - Centre for Sleep Science | Recruiting | Crawley | Western Australia | 6009 | Australia |
| Peking University People's Hospital-Endocrinology | Not yet recruiting | Beijing | Beijing Municipality | 100044 | China |
| Nanfang Hospital, Southern Medical University-Department of Psychiatry and Psychology | Not yet recruiting | Guangzhou | Guangdong | 510515 | China |
| Shenzhen People's Hospital-Sleep Medicine Department | Not yet recruiting | Shenzhen | Guangdong | 518020 | China |
| The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology | Not yet recruiting | Luoyang | Henan | 471003 | China |
| The Second Affiliated Hospital of Nanjing Medical University-Endocrinology | Not yet recruiting | Nanjing | Jiangsu | 210011 | China |
| Tianjin Medical University General Hospital-Respiratory | Not yet recruiting | Tianjin | Tianjin Municipality | 300052 | China |
| Siteworks GmbH Bochum | Recruiting | Bochum | 44787 | Germany |
| Wendisch - Dahl Hamburg - DZHW | Recruiting | Hamburg | 22607 | Germany |
| Siteworks GmbH Hannover | Recruiting | Hanover | 30449 | Germany |
| Siteworks GmbH Karlsruhe | Recruiting | Karlsruhe | 76137 | Germany |
| Institut für Diabetesforschung GmbH Münster - Dr. med. Rose | Recruiting | Münster | 48145 | Germany |
| Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio | Recruiting | Schleswig | 24837 | Germany |
| Guntur Government medical College | Completed | Guntur | Andhra Pradesh | 522004, | India |
| Government Siddhartha Medical College & Government General Hospital, Vijayawada | Not yet recruiting | Vijayawada | Andhra Pradesh | 520008 | India |
| Rajarajeswari Medical College and Hospital | Not yet recruiting | Bengaluru | Karnataka | 560074 | India |
| Amrita Institute Of Medical Sciences & Research Centre | Not yet recruiting | Kochi | Kerala | 682041 | India |
| Bhaktivedanta Hospital & Research Institute | Not yet recruiting | Mumbai | Maharashtra | 401107 | India |
| Asian Kidney Hospital And Medical Centre | Not yet recruiting | Nagpur | Maharashtra | 440010 | India |
| Vardhaman Mahavir Medical College & Safdarjung Hospital | Not yet recruiting | New Delhi | National Capital Territory of Delhi | 110029 | India |
| All India Institute of Medical Sciences_Delhi | Not yet recruiting | Delhi | New Delhi | 110029 | India |
| All India Institute of Medical Sciences (AIIMS), Bhubaneswar | Not yet recruiting | Bhubaneswar | Odisha | 751019 | India |
| Yashoda Hospital | Completed | Hyderabad | Telangana | 500084 | India |
| Midland Healthcare & Research Center | Not yet recruiting | Lucknow | Uttar Pradesh | 226006 | India |
| Apollo Multispeciality Hospital, Kolkata | Not yet recruiting | Kolkata | West Bengal | 700054 | India |
| Asthma Bhawan | Not yet recruiting | Jaipur | 302039 | India |
| Fukuoka University Hospital_Respiratory Medicine | Recruiting | Fukuoka | 814-0180 | Japan |
| Chatani NeuroSleep Clinic_Neurology | Recruiting | Hiroshima | 730-0051 | Japan |
| Kuwamizu Hospital_Internal Medicine | Recruiting | Kumamoto | 862-0954 | Japan |
| Nakamura Clinic_Pulmonology | Recruiting | Okinawa | 901-2132 | Japan |
| Osaka Kaisei Hospital_Sleep Medical Center | Recruiting | Osaka | 532-0003 | Japan |
| KKR Sappro Medical Center_Respiratory Medicine | Recruiting | Sapporo-shi, Hokkaido | 062-0931 | Japan |
| Chutoen General Medical Center_Neurology | Recruiting | Shizuoka | 436-8555 | Japan |
| Tokyo-Eki Center-building Clinic_Internal Medicine | Recruiting | Tokyo | 103-0027 | Japan |
| Juntendo University Hospital_Cardiovascular Biology And Medicine | Recruiting | Tokyo | 113-8431 | Japan |
| Tokyo Tenshi Hospital_Internal medicine | Recruiting | Tokyo | 193-0811 | Japan |
| 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu | Recruiting | Wroclaw | Dolnoslaskie Voivodeship | 50-981 | Poland |
| Uniwersyteckie Centrum Kliniczne | Recruiting | Gdansk | 80-214 | Poland |
| Penta Hospitals Badania Kliniczne Sp. z o.o. | Recruiting | Gdansk | 80-546 | Poland |
| 5 Wojskowy Szpital Kliniczny z Polikliniką-Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie | Not yet recruiting | Krakow | 30-901 | Poland |
| Krakowski Szpital Specjalistyczny im. Jana Pawla II | Completed | Krakow | 31-202 | Poland |
| Uniwersytecki Szpital Kliniczny W Poznaniu | Recruiting | Poznan | 60-569 | Poland |
| Gyncentrum Sp. z o. o. | Recruiting | Warsaw | 00-124 | Poland |
| National Institute Of Tuberculosis And Lung Diseases - Instytut Gruźlicy i Chorób Płuc | Recruiting | Warsaw | 01-138 | Poland |
| PANSTWOWY INSTYTUT MEDYCZNY MSWiA | Recruiting | Warsaw | 02-507 | Poland |
| ETG Warszawa Sp. z o.o. | Recruiting | Warsaw | 02-677 | Poland |
| Hospital Universitario de Guadalajara | Recruiting | Guadalajara | Castille-La Mancha | 19002 | Spain |
| H.U. Quirónsalud Madrid | Recruiting | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Vithas Sevilla | Recruiting | Castilleja de la Cuesta | 41950 | Spain |
| Hospital Univ. de Santa María de Lleida | Recruiting | Lleida | 25198 | Spain |
| Hospital Universitario San Pedro | Recruiting | Logroño | 26006 | Spain |
| Hospital Ramón y Cajal | Recruiting | Madrid | 28034 | Spain |
| Instituto de Investigaciones del Sueño | Recruiting | Madrid | 28036 | Spain |
| Hospital Universitario de Araba | Recruiting | Vitoria-Gasteiz | 01004 | Spain |
| Ditmanson Medical Foundation Chia-Yi Christian Hospital | Not yet recruiting | Chiayi City | 600 | Taiwan |
| Cathay General Hospital | Recruiting | Taipei | 106 | Taiwan |
| Taipei Medical University Hospital | Recruiting | Taipei | 110 | Taiwan |
| Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology | Recruiting | Taipei | 116 | Taiwan |
| Chang Gung Memorial Hospital, Linkou | Not yet recruiting | Taoyuan | 333 | Taiwan |
| T.C. Sağlık Bakanlığı Alaaddin Keykubat Üniversitesi Alanya Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları | Recruiting | Alanya/ Antalya | 07400 | Turkey (Türkiye) |
| İstanbul İl Sağlik Müdürlüğü Süreyyapaşa Göğüs Hastaliklari Ve Göğüs Cerrahisi Eğitim Ve Araştirma Hastanesi | Recruiting | Maltepe/İstanbull | 34843 | Turkey (Türkiye) |
| İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları | Recruiting | Merkez/Battalgazi/Malatya | 44280 | Turkey (Türkiye) |
| Hitit Üniversitesi Çorum Erol Olçok Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları | Recruiting | Merkez/Çorum | 19040 | Turkey (Türkiye) |
| Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları | Recruiting | Yenimahalle / Ankara | 06170 | Turkey (Türkiye) |
| Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye | Recruiting | Yuregir/Adana | 01060 | Turkey (Türkiye) |
| Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları | Recruiting | Yıldırım/Bursa | 16310 | Turkey (Türkiye) |
| Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi | Recruiting | Zeytinburnu/İstanbul | 34020 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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