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) — India Trial Details

Condition(s) studied

ObesityOverweightObstructive Sleep Apnoea

Investigational drug(s) / intervention(s)

NNC0487-0111Placebo (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)

Facility	City	Region	Status
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	Not Yet 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.

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