Obesity Clinical Trial
Official title:
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
Verified date | September 2017 |
Source | Novo Nordisk A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 359 |
Est. completion date | June 17, 2013 |
Est. primary completion date | June 1, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Novo Nordisk Investigational Site | Burlington | Ontario |
Canada | Novo Nordisk Investigational Site | Hamilton | Ontario |
Canada | Novo Nordisk Investigational Site | Toronto | Ontario |
Canada | Novo Nordisk Investigational Site | Toronto | Ontario |
Canada | Novo Nordisk Investigational Site | Toronto | Ontario |
United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
United States | Novo Nordisk Investigational Site | Brandon | Florida |
United States | Novo Nordisk Investigational Site | Chesterfield | Missouri |
United States | Novo Nordisk Investigational Site | Chevy Chase | Maryland |
United States | Novo Nordisk Investigational Site | Chicago | Illinois |
United States | Novo Nordisk Investigational Site | Columbia | South Carolina |
United States | Novo Nordisk Investigational Site | Crestview Hills | Kentucky |
United States | Novo Nordisk Investigational Site | Dallas | Texas |
United States | Novo Nordisk Investigational Site | Dallas | Texas |
United States | Novo Nordisk Investigational Site | Dublin | Ohio |
United States | Novo Nordisk Investigational Site | Fort Worth | Texas |
United States | Novo Nordisk Investigational Site | Glendale | California |
United States | Novo Nordisk Investigational Site | Hollywood | Florida |
United States | Novo Nordisk Investigational Site | Louisville | Kentucky |
United States | Novo Nordisk Investigational Site | Macon | Georgia |
United States | Novo Nordisk Investigational Site | Miami | Florida |
United States | Novo Nordisk Investigational Site | New York | New York |
United States | Novo Nordisk Investigational Site | New York | New York |
United States | Novo Nordisk Investigational Site | North Dartmouth | Massachusetts |
United States | Novo Nordisk Investigational Site | Oceanside | California |
United States | Novo Nordisk Investigational Site | Orange | California |
United States | Novo Nordisk Investigational Site | Overland Park | Kansas |
United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
United States | Novo Nordisk Investigational Site | Philadelphia | Pennsylvania |
United States | Novo Nordisk Investigational Site | Portage | Michigan |
United States | Novo Nordisk Investigational Site | Redwood City | California |
United States | Novo Nordisk Investigational Site | Saint Petersburg | Florida |
United States | Novo Nordisk Investigational Site | San Diego | California |
United States | Novo Nordisk Investigational Site | Santa Monica | California |
United States | Novo Nordisk Investigational Site | South Miami | Florida |
United States | Novo Nordisk Investigational Site | Tampa | Florida |
United States | Novo Nordisk Investigational Site | Vernon Hills | Illinois |
United States | Novo Nordisk Investigational Site | Vienna | Virginia |
United States | Novo Nordisk Investigational Site | Warwick | Rhode Island |
United States | Novo Nordisk Investigational Site | West Palm Beach | Florida |
United States | Novo Nordisk Investigational Site | Wilmington | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
United States, Canada,
Bays H, Pi-Sunyer X, Hemmingsson JU, Claudius B, Jensen CB, Van Gaal L. Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects. Curr Med Res Opin. 2017 Feb;33(2):225-229. doi: 10.1080/03007995.2016.1251892. Epub 2016 Nov 6 — View Citation
Blackman A, Foster GD, Zammit G, Rosenberg R, Aronne L, Wadden T, Claudius B, Jensen CB, Mignot E. Effect of liraglutide 3.0 mg in individuals with obesity and moderate or severe obstructive sleep apnea: the SCALE Sleep Apnea randomized clinical trial. In — View Citation
Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or — View Citation
O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3 — View Citation
O'Neil PM, Garvey WT, Gonzalez-Campoy JM, Mora P, Ortiz RV, Guerrero G, Claudius B, Pi-Sunyer X; Satiety and Clinical Adiposity – Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT A — View Citation
Steinberg WM, Rosenstock J, Wadden TA, Donsmark M, Jensen CB, DeVries JH. Impact of Liraglutide on Amylase, Lipase, and Acute Pancreatitis in Participants With Overweight/Obesity and Normoglycemia, Prediabetes, or Type 2 Diabetes: Secondary Analyses of Po — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Apnoea-hypopnoea Index (AHI) | 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. | Week 0, Week 32 | |
Secondary | Change From Baseline in Body Weight (kg) | Observed mean change from baseline in fasting body weight (kg) after 32 weeks of treatment. | Week 0, week 32 | |
Secondary | Change From Baseline in Fasting Plasma Glucose | Observed mean change from baseline in fasting plasma glucose (mmol/L) after 32 weeks of treatment. | Week 0, week 32 | |
Secondary | Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) | Observed mean change from baseline in glycosylated haemoglobin (HbA1c) (%) after 32 weeks of treatment. | Week 0, week 32 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |