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Purpose

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.

Conditions

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

ArmDescriptionAssigned 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.
  • 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.
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.
  • 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.

Recruiting Locations

Dignity Health, Mercy Gilbert
Gilbert, Arizona 85297

DM Clinical
Bradenton, Florida 34209

Essence MD Research
Naples, Florida 34102

Palm Beach Research Center
West Palm Beach, Florida 33409

NeuroTrials Research, Inc.
Atlanta, Georgia 30328

Physicians Research Associates
Lawrenceville, Georgia 30046

Chicago Research Center, Inc
Chicago, Illinois 60634

Lillestol Research LLC
Fargo, North Dakota 58104

CTI Clinical Research Center
Cincinnati, Ohio 45212

Bogan Sleep Consultants, LLC
Columbia, South Carolina 29201

Epic Medical Research
DeSoto, Texas 75115

Advanced Neurology Epilepsy and Sleep Center ANESC
El Paso, Texas 79912

Biorhythms Center for Integrative Sleep Medicine
El Paso, Texas 79912

Houston Pulmonary Medicine Associates, PA
Houston, Texas 77089

Sleep Therapy Research Center
San Antonio, Texas 78229

Tricoastal Sleep Center
Sugar Land, Texas 77478

Rainier Clin Res Ctr Inc
Renton, Washington 98057

Seattle Clinical Research Center
Seattle, Washington 98104

More Details

Status
Recruiting
Sponsor
Novo Nordisk A/S

Study Contact

Novo Nordisk
(+1) 866-867-7178
clinicaltrials@novonordisk.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.