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

Phase 3

Completed

Conditions: Obesity
Obstructive Sleep Apnoea
Metabolism and Nutrition Disorder

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
Liraglutide 3.0 mg	liraglutide	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Apnoea-hypopnoea Index (AHI)	Week 0, Week 32	Observed mean change from baseline in AHI (events/hour) after 32 weeks of treatment. AHI (apnoea and hypopnoea events per hour of sleep) is a measure used for the diagnosis and severity classification of obstructive sleep apnoea. AHI severity category: none ≤4.9; mild 5.0-14.9; moderate 15.0-29.9; severe ≥30.0 events/hour.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose	Week 0, week 32	Observed mean change from baseline in fasting plasma glucose (mmol/L) after 32 weeks of treatment.
Change From Baseline in Body Weight (kg)	Week 0, week 32	Observed mean change from baseline in fasting body weight (kg) after 32 weeks of treatment.
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)	Week 0, week 32	Observed mean change from baseline in glycosylated haemoglobin (HbA1c) (%) after 32 weeks of treatment.