Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea: SCALE™ - Sleep Apnoea

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Metabolism and Nutrition Disorder

Obstructive Sleep Apnoea

Obesity

Treatments

Drug: liraglutide

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

U1111-1126-6260 (Other Identifier)

NN8022-3970

Details and patient eligibility

About

This trial is conducted in North America. The aim of the trial is to investigate the effect of liraglutide in obese subjects with sleep apnoea.

Enrollment

359 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Informed consent
Body mass index equal to or above 30 kg/m^2
Stable body weight (less than 5% self-reported change during the previous 3 months)
Diagnosis of moderate or severe obstructive sleep apnoea (OSA)
Unwilling or unable to use continuous positive airway pressure (CPAP) (or other positive airway pressure) treatment. No CPAP (or other positive airway pressure) treatment for at least four weeks prior to screening
Ability and willingness to comply with all protocol procedures e.g. correct handling of trial product, compliance to visit schedule and dietary advice and complete trial related questionnaires

Exclusion criteria

Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 inhibitors or insulin within the last 3 months prior to screening
Diagnosis of type 1 or type 2 diabetes per judgement of the investigator
Glycosylated haemoglobin (HbA1c) equal to or above 6.5%
Significant craniofacial abnormalities that may cause OSA
Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator
Use of central stimulants, hypnotics, mirtazepine, opioids, trazodone within the previous 3 months prior to screening
Obesity induced by drug treatment
Treatment with pramlintide, sibutramine, orlistat, zonisamide, topiramate or phenteremine within the last 3 month prior to screening
Previous surgical treatment for obesity
Screening calcitonin equal to or above 50 ng/L
Familial or personal history of Multiple Endocrine Neoplasia type 2 or familial Medullary Thyroid Carcinoma
Personal history of non-familial Medullary Thyroid Carcinoma
History of chronic pancreatitis or idiopathic acute pancreatitis
History of Major Depressive Disorder or suicide attempts
Systolic blood pressure equal to or above 160 mmHg and/or diastolic blood pressure equal to or above 100 mmHg