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



Status:Completed
Conditions:Insomnia Sleep Studies, Obesity Weight Loss, Pulmonary
Therapuetic Areas:Endocrinology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 64
Updated:11/3/2017
Start Date:June 7, 2012
End Date:June 17, 2013

Use our guide to learn which trials are right for you!

Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea. A 32 Week Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre and Multinational Trial

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.


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
We found this trial at
34
sites
920 Massachusetts Avenue Northwest
Chevy Chase, Maryland 20815
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
Atlanta, Georgia 30318
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Brandon, Florida 33511
?
mi
from
Brandon, FL
Click here to add this to my saved trials
2476 Argentia Road
Burlington, Ontario L5N 6M1
?
mi
from
Burlington,
Click here to add this to my saved trials
Chesterfield, Missouri 63017
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Columbia, South Carolina 29203
?
mi
from
Columbia, SC
Click here to add this to my saved trials
Crestview Hills, Kentucky 41017
?
mi
from
Crestview Hills, KY
Click here to add this to my saved trials
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dublin, OH
Click here to add this to my saved trials
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Glendale, California 91206
?
mi
from
Glendale, CA
Click here to add this to my saved trials
Hollywood, Florida 33024
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Louisville, Kentucky 40213
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Macon, Georgia 31201
?
mi
from
Macon, GA
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
North Dartmouth, Massachusetts 02747
?
mi
from
North Dartmouth, MA
Click here to add this to my saved trials
Oceanside, California 92056
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
Overland Park, Kansas 66209
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Portage, Michigan 49024
?
mi
from
Portage, MI
Click here to add this to my saved trials
Redwood City, California 94062
?
mi
from
Redwood City, CA
Click here to add this to my saved trials
Saint Petersburg, Florida 33713
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
San Diego, California 92111
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
South Miami, Florida 33143
?
mi
from
South Miami, FL
Click here to add this to my saved trials
Tampa, Florida 33612
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Vernon Hills, Illinois 60061
?
mi
from
Vernon Hills, IL
Click here to add this to my saved trials
920 Massachusetts Avenue Northwest
Vienna, Virginia 22182
?
mi
from
Vienna, VA
Click here to add this to my saved trials
Warwick, Rhode Island 02886
?
mi
from
Warwick, RI
Click here to add this to my saved trials
West Palm Beach, Florida 33409
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
Wilmington, North Carolina 28401
?
mi
from
Wilmington, NC
Click here to add this to my saved trials