Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea: SCALE™ - Sleep Apnoea
Condition: Metabolism and Nutrition Disorder; Obesity; Obstructive Sleep Apnoea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Nutrition Disorders
Intervention: liraglutide; placebo
Intervention description: 3.0 mg liraglutide administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise; Placebo administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 359.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: OSA

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.
    

Eligibility criteria:

        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