Recruiting NCT07571109
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NNC0487-0111, Placebo (matched to NNC0487-0111).
- Who it may be relevant to
- Registry conditions: Obesity, Overweight, Obstructive Sleep Apnoea. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, China, Germany, India +5
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Obstructive Sleep Apnoea Treated With Positive Airway Pressure (AMAZE 4)
Overview
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.
Interventions
- Drug NNC0487-0111
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. - Drug Placebo (matched to NNC0487-0111)
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.
Primary outcome measures
- Relative change in body weight [Time frame: From baseline (week 0) to (week 80)]
- Change in apnoea-hypopnoea index (AHI) [Time frame: From baseline (week 0) to (week 80)]
Secondary outcome measures (12)
- Relative change in AHI [Time frame: From baseline (week 0) to (week 80)]
- Achievement of 50% reduction in AHI (Yes/No) [Time frame: From baseline (week 0) to (week 80)]
- Achievement of: AHI less than (<) 5 [Time frame: From baseline (week 0) to (week 80)]
- Achievement of: AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤ 10 (Yes/No) [Time frame: From baseline (week 0) to (week 80)]
- Change in sleep apnoea specific hypoxic burden (SASHB) [Time frame: From baseline (week 0) to (week 80)]
- Change in ESS score [Time frame: 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 [Time frame: From baseline (week 0) to (week 80)]
- Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score [Time frame: From baseline (week 0) to (week 80)]
- Change in body weight [Time frame: From baseline (week 0) to (week 80)]
- Change in body mass index (BMI) [Time frame: From baseline (week 0) to (week 80)]
- Improvement in obstructive sleep apnoea (OSA) severity category: AHI < 5/hour = normal (Yes/No) [Time frame: From baseline (week 0) to (week 80)]
- Improvement in OSA severity category: ≥ 5 and < 15/hour = mild (Yes/No) [Time frame: From baseline (week 0) to (week 80)]
Eligibility criteria
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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 20 centers
- Dignity Health, Mercy Gilbert — Gilbert
- DM Clinical — Bradenton
- Essence MD Research — Naples
- Palm Beach Research Center — West Palm Beach
- NeuroTrials Research, Inc. — Atlanta
- Physicians Research Associates — Lawrenceville
- Chicago Research Center, Inc — Chicago
- Weil Cornell Medicine — New York
- … and 12 more centers
India · 13 centers
- Guntur Government medical College — Guntur
- Government Siddhartha Medical College & Government General Hospital, Vijayawada — Vijayawada
- Rajarajeswari Medical College and Hospital — Bengaluru
- Amrita Institute Of Medical Sciences & Research Centre — Kochi
- Bhaktivedanta Hospital & Research Institute — Mumbai
- Asian Kidney Hospital And Medical Centre — Nagpur
- Vardhaman Mahavir Medical College & Safdarjung Hospital — New Delhi
- All India Institute of Medical Sciences_Delhi — Delhi
- … and 5 more centers
Japan · 10 centers
- Fukuoka University Hospital_Respiratory Medicine — Fukuoka
- Chatani NeuroSleep Clinic_Neurology — Hiroshima
- Kuwamizu Hospital_Internal Medicine — Kumamoto
- Nakamura Clinic_Pulmonology — Okinawa
- Osaka Kaisei Hospital_Sleep Medical Center — Osaka
- KKR Sappro Medical Center_Respiratory Medicine — Sapporo-shi, Hokkaido
- Chutoen General Medical Center_Neurology — Shizuoka
- Tokyo-Eki Center-building Clinic_Internal Medicine — Tokyo
- … and 2 more centers
Poland · 10 centers
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej — Wroclaw
- Uniwersyteckie Centrum Kliniczne — Gdansk
- Penta Hospitals Badania Kliniczne Sp. z o.o. — Gdansk
- 5 Wojskowy Szpital Kliniczny z Polikliniką-Samodzielny Publiczny Zakład Opieki Zdrowotnej — Krakow
- Krakowski Szpital Specjalistyczny im. Jana Pawla II — Krakow
- Uniwersytecki Szpital Kliniczny W Poznaniu — Poznan
- Gyncentrum Sp. z o. o. — Warsaw
- National Institute Of Tuberculosis And Lung Diseases - Instytut Gruźlicy i Chorób Płuc — Warsaw
- … and 2 more centers
Spain · 9 centers
- Hospital Universitario de Guadalajara — Guadalajara
- H.U. Quirónsalud Madrid — Pozuelo de Alarcón
- Hospital Vall d'Hebron — Barcelona
- Hospital Vithas Sevilla — Castilleja de la Cuesta
- Hospital Univ. de Santa María de Lleida — Lleida
- Hospital Universitario San Pedro — Logroño
- Hospital Ramón y Cajal — Madrid
- Instituto de Investigaciones del Sueño — Madrid
- … and 1 more center
Turkey (Türkiye) · 8 centers
Center list to be confirmed — check the primary protocol.
China · 6 centers
- Peking University People's Hospital-Endocrinology — Beijing
- Nanfang Hospital, Southern Medical University-Department of Psychiatry and Psychology — Guangzhou
- Shenzhen People's Hospital-Sleep Medicine Department — Shenzhen
- The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology — Luoyang
- The Second Affiliated Hospital of Nanjing Medical University-Endocrinology — Nanjing
- Tianjin Medical University General Hospital-Respiratory — Tianjin
Germany · 6 centers
- Siteworks GmbH Bochum — Bochum
- Wendisch - Dahl Hamburg - DZHW — Hamburg
- Siteworks GmbH Hannover — Hanover
- Siteworks GmbH Karlsruhe — Karlsruhe
- Institut für Diabetesforschung GmbH Münster - Dr. med. Rose — Münster
- Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio — Schleswig
Australia · 5 centers
- Woolcock Institute — Macquarie Park
- University of Sunshine Coast - Vitality Village — Birtinya
- Mater Research - RIO Clinical Trials Unit — South Brisbane
- Nightingale Research Adelaide — Adelaide
- University of Western Australia - Centre for Sleep Science — Crawley
Taiwan · 5 centers
- Ditmanson Medical Foundation Chia-Yi Christian Hospital — Chiayi City
- … and 4 more centers
Identifiers
NCT: NCT07571109 · NN9490-8293 · U1111-1313-6538 · 2024-520443-16