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Clinical Trials in Australia / NCT07571109
Recruiting Phase 3

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

NCT07571109 · tracked via the Priya Life Science Australia tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2026-05-05
Last updated
2026-10-07

Condition(s) studied

ObesityOverweightObstructive Sleep Apnoea

Investigational drug(s) / intervention(s)

NNC0487-0111 →Placebo (matched to NNC0487-0111)

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.

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key 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

Primary outcome measure(s)

  • Relative change in body weight — From baseline (week 0) to (week 80)
    Measured as percentage (%) change in body weight.
  • Change in apnoea-hypopnoea index (AHI) — From baseline (week 0) to (week 80)
    Measured as events/hour.

Trial sites (92)

FacilityCityRegionStatus
Dignity Health, Mercy Gilbert Gilbert Arizona Recruiting
DM Clinical Bradenton Florida Recruiting
Essence MD Research Naples Florida Recruiting
Palm Beach Research Center West Palm Beach Florida Recruiting
NeuroTrials Research, Inc. Atlanta Georgia Recruiting
Physicians Research Associates Lawrenceville Georgia Recruiting
Chicago Research Center, Inc Chicago Illinois Recruiting
Weil Cornell Medicine New York New York Recruiting
Lillestol Research LLC Fargo North Dakota Recruiting
CTI Clinical Research Center Cincinnati Ohio Recruiting
Clinical Research Associates of Central PA, LLC DuBois Pennsylvania Not Yet Recruiting
Bogan Sleep Consultants, LLC Columbia South Carolina Recruiting
Epic Medical Research DeSoto Texas Recruiting
Advanced Neurology Epilepsy and Sleep Center ANESC El Paso Texas Recruiting
Biorhythms Center for Integrative Sleep Medicine El Paso Texas Recruiting
Houston Pulm Med Res Network Houston Texas Recruiting
Sleep Therapy Research Center San Antonio Texas Recruiting
Tricoastal Sleep Center Sugar Land Texas Recruiting
Rainier Clin Res Ctr Inc Renton Washington Recruiting
Seattle Clinical Research Center Seattle Washington Recruiting
Woolcock Institute Macquarie Park New South Wales Recruiting
University of Sunshine Coast - Vitality Village Birtinya Queensland Recruiting
Mater Research - RIO Clinical Trials Unit South Brisbane Queensland Not Yet Recruiting
Nightingale Research Adelaide Adelaide South Australia Recruiting
University of Western Australia - Centre for Sleep Science Crawley Western Australia Recruiting
Peking University People's Hospital-Endocrinology Beijing Beijing Municipality Recruiting
Nanfang Hospital, Southern Medical University-Department of Psychiatry and Psychology Guangzhou Guangdong Not Yet Recruiting
Shenzhen People's Hospital-Sleep Medicine Department Shenzhen Guangdong Recruiting
The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology Luoyang Henan Not Yet Recruiting
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology Nanjing Jiangsu Recruiting
Tianjin Medical University General Hospital-Respiratory Tianjin Tianjin Municipality Not Yet Recruiting
Siteworks GmbH Bochum Bochum Germany Recruiting
Wendisch - Dahl Hamburg - DZHW Hamburg Germany Recruiting
Siteworks GmbH Hannover Hanover Germany Recruiting
Siteworks GmbH Karlsruhe Karlsruhe Germany Recruiting
Institut für Diabetesforschung GmbH Münster - Dr. med. Rose Münster Germany Recruiting
Siteworks GmbH - Prüfzentrum Schleswig | RespiRatio Schleswig Germany Recruiting
Guntur Government medical College Guntur Andhra Pradesh Completed
Government Siddhartha Medical College & Government General Hospital, Vijayawada Vijayawada Andhra Pradesh Recruiting
Rajarajeswari Medical College and Hospital Bengaluru Karnataka Recruiting

+ 52 more sites — see the full list on the official registry below.

More Novo Nordisk A/S trials in Australia

A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A Starting soon
AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight Recruiting
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 Recruiting
A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation Active, not recruiting
Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide Active, not recruiting

Other trials for the same condition

A Trial of HRS-5817 in Obese Participants Active, not recruiting
Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes Active, not recruiting
A Study of Tirzepatide in Adolescents With Obesity and Weight-Related Comorbidities (SURMOUNT-ADOLESCENTS-2) Recruiting
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION) Recruiting
AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07571109 on ClinicalTrials.gov ↗ ← All trials in Australia