AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea
Recruiting · NCT07571109 · Interventional (participants receive a specific treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
NNC0487-0111Placebo (matched to NNC0487-0111)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male or female (sex at birth)
- Age 18 years or above at the time of signing informed consent
- Previously diagnosed moderate-to-severe OSA with an AHI ≥ 15, as diagnosed with polysomnography (PSG), home sleep apnoea test (HSAT), or other method that meets local guidelines prior to screening
- Key
Exclusion criteria
- Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening
- History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records
- Any planned or previous surgery within 90 days prior to screening for sleep apnoea, including septoplasty, turbinoplasty, or other ear, nose, and throat surgeries, including tonsillectomy and adenoidectomy
- Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence
- Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonist (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening
Where it is running
60 locations listed across 11 US states.
- Dignity Health, Mercy Gilbert - Gilbert, Arizona, United States
- DM Clinical - Bradenton, Florida, United States
- Essence MD Research - Naples, Florida, United States
- Palm Beach Research Center - West Palm Beach, Florida, United States
- NeuroTrials Research, Inc. - Atlanta, Georgia, United States
- Physicians Research Associates - Lawrenceville, Georgia, United States
- Chicago Research Center, Inc - Chicago, Illinois, United States
- Weil Cornell Medicine - New York, New York, United States
- Lillestol Research LLC - Fargo, North Dakota, United States
- CTI Clinical Research Center - Cincinnati, Ohio, United States
- Clinical Research Associates of Central PA, LLC - DuBois, Pennsylvania, United States
- Bogan Sleep Consultants, LLC - Columbia, South Carolina, United States
- Epic Medical Research - DeSoto, Texas, United States
- Advanced Neurology Epilepsy and Sleep Center ANESC - El Paso, Texas, United States
- Biorhythms Center for Integrative Sleep Medicine - El Paso, Texas, United States
- Houston Pulm Med Res Network - Houston, Texas, United States
- Sleep Therapy Research Center - San Antonio, Texas, United States
- Tricoastal Sleep Center - Sugar Land, Texas, United States
- Rainier Clin Res Ctr Inc - Renton, Washington, United States
- Seattle Clinical Research Center - Seattle, Washington, United States
- T.C. Sağlık Bakanlığı Alaaddin Keykubat Üniversitesi Alanya Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları - Alanya/ Antalya, Turkey (Türkiye)
- Hospital Vall d'Hebron - Barcelona, Spain
- Siteworks GmbH Bochum - Bochum, Germany
- Hospital Vithas Sevilla - Castilleja de la Cuesta, Spain
- Ditmanson Medical Foundation Chia-Yi Christian Hospital - Chiayi City, Taiwan
- Fukuoka University Hospital_Respiratory Medicine - Fukuoka, Japan
- Uniwersyteckie Centrum Kliniczne - Gdansk, Poland
- Penta Hospitals Badania Kliniczne Sp. z o.o. - Gdansk, Poland
- Wendisch - Dahl Hamburg - DZHW - Hamburg, Germany
- Siteworks GmbH Hannover - Hanover, Germany
- Chatani NeuroSleep Clinic_Neurology - Hiroshima, Japan
- Asthma Bhawan - Jaipur, India
- Siteworks GmbH Karlsruhe - Karlsruhe, Germany
- 5 Wojskowy Szpital Kliniczny z Polikliniką-Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie - Krakow, Poland
- Krakowski Szpital Specjalistyczny im. Jana Pawla II - Krakow, Poland
- Kuwamizu Hospital_Internal Medicine - Kumamoto, Japan
- Hospital Univ. de Santa María de Lleida - Lleida, Spain
- Hospital Universitario San Pedro - Logroño, Spain
- Hospital Ramón y Cajal - Madrid, Spain
- Instituto de Investigaciones del Sueño - Madrid, Spain
- İstanbul İl Sağlik Müdürlüğü Süreyyapaşa Göğüs Hastaliklari Ve Göğüs Cerrahisi Eğitim Ve Araştirma Hastanesi - Maltepe/İstanbull, Turkey (Türkiye)
- İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları - Merkez/Battalgazi/Malatya, Turkey (Türkiye)
- Hitit Üniversitesi Çorum Erol Olçok Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları - Merkez/Çorum, Turkey (Türkiye)
- Institut für Diabetesforschung GmbH Münster - Dr. med. Rose - Münster, Germany
- Nakamura Clinic_Pulmonology - Okinawa, Japan
- Osaka Kaisei Hospital_Sleep Medical Center - Osaka, Japan
- Uniwersytecki Szpital Kliniczny W Poznaniu - Poznan, Poland
- KKR Sappro Medical Center_Respiratory Medicine - Sapporo-shi, Hokkaido, Japan
- Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio - Schleswig, Germany
- Chutoen General Medical Center_Neurology - Shizuoka, Japan
- Cathay General Hospital - Taipei, Taiwan
- Taipei Medical University Hospital - Taipei, Taiwan
- Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology - Taipei, Taiwan
- Chang Gung Memorial Hospital, Linkou - Taoyuan, Taiwan
- Tokyo-Eki Center-building Clinic_Internal Medicine - Tokyo, Japan
- Juntendo University Hospital_Cardiovascular Biology And Medicine - Tokyo, Japan
- Tokyo Tenshi Hospital_Internal medicine - Tokyo, Japan
- Hospital Universitario de Araba - Vitoria-Gasteiz, Spain
- Gyncentrum Sp. z o. o. - Warsaw, Poland
- National Institute Of Tuberculosis And Lung Diseases - Instytut Gruźlicy i Chorób Płuc - Warsaw, Poland
Showing 60 of 92 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →