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Recruiting NCT07571005

AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea

Phase III Interventional Obesity Overweight Obstructive 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, Denmark, Germany +5
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure (AMAZE 3)

Overview

This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with excess body weight and obstructive sleep apnoea not treated with positive airway pressure lose weight and improve sleep apnoea. 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 obstructive sleep apnoea (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 · 17 centers
  • Artemis Insitute for Clin Res — San Diego
  • PharmaDev Clinical Research Institute LLC — Miami
  • Essence MD Research — Naples
  • Renstar Medical Research — Ocala
  • Conquest Research — Atlanta
  • Physicians Research Associates — Lawrenceville
  • University Of Chicago — Chicago
  • Weil Cornell Medicine — New York
  • … and 9 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
  • All India Institute of Medical Sciences_Delhi — Delhi
  • All India Institute of Medical Sciences (AIIMS), Bhubaneswar — Bhubaneswar
  • … and 5 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
  • T.C. Sağlık Bakanlığı Alaaddin Keykubat Üniversitesi Alanya Eğitim ve Araştırma Hastanesi- — Alanya/ Antalya
  • İstanbul İl Sağlik Müdürlüğü Süreyyapaşa Göğüs Hastaliklari Ve Göğüs Cerrahisi Eğitim Ve A — Maltepe/İstanbull
  • İnönü Üniversitesi Turgut Özal Tıp Merkezi Hastanesi- Göğüs Hastalıkları — Merkez/Battalgazi/Malatya
  • Hitit Üniversitesi Çorum Erol Olçok Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları — Merkez/Çorum
  • Ankara Etlik Şehir Hastanesi-Göğüs Hastalıkları — Yenimahalle / Ankara
  • Adana Şehir Eğitim ve Araştırma Hastanesi-Dahiliye — Yuregir/Adana
  • Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi-Göğüs Hastalıkları — Yıldırım/Bursa
  • Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi — Zeytinburnu/İstanbul
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
  • University of Western Australia - Centre for Sleep Science — Crawley
China · 5 centers
  • Peking University People's Hospital-Endocrinology — Beijing
  • The Second Affiliated Hospital of Nanjing Medical University-Endocrinology — Nanjing
  • The First Affiliated Hospital of Soochow University-Endocrinology — Suzhou
  • The Affiliated Hospital of Jiangsu University-Endocrinology — Zhenjiang
  • Huzhou Central Hospital-Endocrinology — Huzhou
Taiwan · 5 centers
  • Ditmanson Medical Foundation Chia-Yi Christian Hospital — Chiayi City
  • Cathay General Hospital — Taipei
  • Taipei Medical University Hospital — Taipei
  • Taipei Municipal Wan Fang Hospital_Division of Otorhinolaryngology — Taipei
  • Chang Gung Memorial Hospital, Linkou — Taoyuan
Denmark · 2 centers
  • Regionshospitalet Gødstrup, Øre-næse-hals-kirurgisk — Herning
  • Sjællands Universitetshospital, Køge - Øre-Næse-Hals afdeling — Køge

Identifiers

NCT: NCT07571005 · NN9490-8025 · U1111-1313-6359 · 2024-520442-36

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗