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
Purpose
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.
Conditions
- Obesity
- Overweight
- Obstructive Sleep Apnoea
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NNC0487-0111 |
Participants will be randomized to receive 1 of the 2 dose levels of NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
|
|
Placebo Comparator Placebo |
Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. |
|
Recruiting Locations
Artemis Insitute for Clin Res
San Diego, California 92123
San Diego, California 92123
PharmaDev Clinical Research Institute LLC
Miami, Florida 33176
Miami, Florida 33176
Renstar Medical Research
Ocala, Florida 34470
Ocala, Florida 34470
Conquest Research
Atlanta, Georgia 30328
Atlanta, Georgia 30328
Physicians Research Associates
Lawrenceville, Georgia 30046
Lawrenceville, Georgia 30046
CTI Clinical Research Center
Cincinnati, Ohio 45212
Cincinnati, Ohio 45212
Epic Medical Research
DeSoto, Texas 75115
DeSoto, Texas 75115
Advanced Neurology Epilepsy and Sleep Center ANESC
El Paso, Texas 79912
El Paso, Texas 79912
Biorhythms Center for Integrative Sleep Medicine
El Paso, Texas 79912
El Paso, Texas 79912
Houston Pulmonary Medicine Associates, PA
Houston, Texas 77089
Houston, Texas 77089
Sleep Therapy Research Center
San Antonio, Texas 78229
San Antonio, Texas 78229
Tricoastal Sleep Center
Sugar Land, Texas 77478
Sugar Land, Texas 77478
Rainier Clin Res Ctr Inc
Renton, Washington 98057
Renton, Washington 98057
More Details
- Status
- Recruiting
- Sponsor
- Novo Nordisk A/S