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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

359

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jun 2012

Shorter than P25 for phase_3

Geographic Reach

2 countries

42 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

First Submitted

Initial submission to the registry

March 15, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2012

Completed

3 months until next milestone

Study Start

First participant enrolled

June 7, 2012

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed

16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2013

Completed

1.6 years until next milestone

Results Posted

Study results publicly available

February 9, 2015

Completed

Last Updated

November 1, 2017

Status Verified

September 1, 2017

Enrollment Period

12 months

First QC Date

March 15, 2012

Results QC Date

January 22, 2015

Last Update Submit

September 29, 2017

Conditions

Metabolism and Nutrition Disorder Obesity Obstructive Sleep Apnoea

Keywords

OSA

Outcome Measures

Primary Outcomes (1)

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 Outcomes (3)

Change From Baseline in Body Weight (kg)
Week 0, week 32
Change From Baseline in Fasting Plasma Glucose
Week 0, week 32
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)
Week 0, week 32

Study Arms (2)

Liraglutide 3.0 mg

EXPERIMENTAL

Drug: liraglutide

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

liraglutideDRUG

3.0 mg liraglutide administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise

Liraglutide 3.0 mg

placeboDRUG

Placebo administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise

Placebo

Eligibility Criteria

Age18 Years - 64 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

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

Contact the study team to confirm eligibility.