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

Completed · Phase 3 · Has a placebo group

Conditions studied: Metabolism and Nutrition Disorder, Obesity, Obstructive Sleep Apnoea

In brief

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.

Key facts

Study ID

NCT01557166

Run by

Novo Nordisk A/S

People needed

359

Starts

2012-06-07

Expected to finish

2013-06-17

Last updated by the study team

2017-11-01

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Glendale, California, United States
• Novo Nordisk Investigational Site — Oceanside, California, United States
• Novo Nordisk Investigational Site — Orange, California, United States
• Novo Nordisk Investigational Site — Redwood City, California, United States
• Novo Nordisk Investigational Site — San Diego, California, United States
• Novo Nordisk Investigational Site — Santa Monica, California, United States
• Novo Nordisk Investigational Site — Brandon, Florida, United States
• Novo Nordisk Investigational Site — Hollywood, Florida, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — South Miami, Florida, United States
• Novo Nordisk Investigational Site — St. Petersburg, Florida, United States
• Novo Nordisk Investigational Site — Tampa, Florida, United States
• Novo Nordisk Investigational Site — West Palm Beach, Florida, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Macon, Georgia, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — Vernon Hills, Illinois, United States
• Novo Nordisk Investigational Site — Overland Park, Kansas, United States
• Novo Nordisk Investigational Site — Crestview Hills, Kentucky, United States
• Novo Nordisk Investigational Site — Louisville, Kentucky, United States
• Novo Nordisk Investigational Site — Chevy Chase, Maryland, United States
• Novo Nordisk Investigational Site — North Dartmouth, Massachusetts, United States
• Novo Nordisk Investigational Site — Portage, Michigan, United States
• Novo Nordisk Investigational Site — Chesterfield, Missouri, United States
• Novo Nordisk Investigational Site — New York, New York, United States

Full record on ClinicalTrials.gov

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