Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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
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

RecruitingPhase 3

Sponsor: Novo Nordisk A/S

Conditions: Obesity, Overweight, Obstructive Sleep Apnoea

Interventions: NNC0487-0111, Placebo (matched to NNC0487-0111)

Countries: United States, Australia, China, Germany, India, Japan, Poland, Spain

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (92)
  • Gilbert, Arizona, United States
  • Bradenton, Florida, United States
  • Naples, Florida, United States
  • West Palm Beach, Florida, United States
  • Atlanta, Georgia, United States
  • Lawrenceville, Georgia, United States
  • Chicago, Illinois, United States
  • New York, New York, United States
  • Fargo, North Dakota, United States
  • Cincinnati, Ohio, United States
  • DuBois, Pennsylvania, United States
  • Columbia, South Carolina, United States
  • DeSoto, Texas, United States
  • El Paso, Texas, United States
  • El Paso, Texas, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
  • Sugar Land, Texas, United States
  • Renton, Washington, United States
  • Seattle, Washington, United States
  • Macquarie Park, New South Wales, Australia
  • Birtinya, Queensland, Australia
  • South Brisbane, Queensland, Australia
  • Adelaide, South Australia, Australia
  • Crawley, Western Australia, Australia
  • Beijing, Beijing Municipality, China
  • Guangzhou, Guangdong, China
  • Shenzhen, Guangdong, China
  • Luoyang, Henan, China
  • Nanjing, Jiangsu, China
  • + 62 more on CT.gov