Metabolism and Nutrition DisorderPhase 3NCT01557166

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

A Phase 3 study testing liraglutide in people with Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 42 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Metabolism and Nutrition Disorder, Obesity, Obstructive Sleep Apnoea
What is being tested?: liraglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 359 participants
Where: 42 sitesin 2 countries
Study dates: 7 Jun 2012to 17 Jun 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

42 sites in 2 countries.

Country

City, postcode or hospital

42 sites in 2 countries

United States37 sites

Novo Nordisk Investigational Site
Atlanta, Georgia, 30342
Novo Nordisk Investigational Site
Brandon, Florida, 33511
Novo Nordisk Investigational Site
Chesterfield, Missouri, 63017
Novo Nordisk Investigational Site
Chevy Chase, Maryland, 20815-6905
Novo Nordisk Investigational Site
Chicago, Illinois, 60634
Novo Nordisk Investigational Site
Columbia, South Carolina, 29201-2951
Novo Nordisk Investigational Site
Crestview Hills, Kentucky, 41017-3464
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Dallas, Texas, 75234
Novo Nordisk Investigational Site
Dublin, Ohio, 43017-3521
Novo Nordisk Investigational Site
Fort Worth, Texas, 76135
Novo Nordisk Investigational Site
Glendale, California, 91206
Novo Nordisk Investigational Site
Hollywood, Florida, 33024
Novo Nordisk Investigational Site
Louisville, Kentucky, 40218
Novo Nordisk Investigational Site
Macon, Georgia, 31201
Novo Nordisk Investigational Site
Miami, Florida, 33155
Novo Nordisk Investigational Site
New York, New York, 10019
Novo Nordisk Investigational Site
New York, New York, 10065
Novo Nordisk Investigational Site
North Dartmouth, Massachusetts, 02747
Novo Nordisk Investigational Site
Oceanside, California, 92054
Novo Nordisk Investigational Site
Orange, California, 92868
Novo Nordisk Investigational Site
Overland Park, Kansas, 66212
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19104-3317
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19118
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19140
Novo Nordisk Investigational Site
Portage, Michigan, 49024-4889
Novo Nordisk Investigational Site
Redwood City, California, 94063
Novo Nordisk Investigational Site
San Diego, California, 92103-5801
Novo Nordisk Investigational Site
Santa Monica, California, 90404
Novo Nordisk Investigational Site
South Miami, Florida, 33143
Novo Nordisk Investigational Site
St. Petersburg, Florida, 33707
Novo Nordisk Investigational Site
Tampa, Florida, 33603
Novo Nordisk Investigational Site
Vernon Hills, Illinois, 60061
Novo Nordisk Investigational Site
Vienna, Virginia, 22182
Novo Nordisk Investigational Site
Warwick, Rhode Island, 02886
Novo Nordisk Investigational Site
West Palm Beach, Florida, 33409
Novo Nordisk Investigational Site
Wilmington, North Carolina, 28401

Other trials in United States

Canada5 sites

Novo Nordisk Investigational Site
Burlington, Ontario, L7R 1E2
Novo Nordisk Investigational Site
Hamilton, Ontario, L8L 5G8
Novo Nordisk Investigational Site
Toronto, Ontario, M4P 1P2
Novo Nordisk Investigational Site
Toronto, Ontario, M5M 1C7
Novo Nordisk Investigational Site
Toronto, Ontario, M5M1C7

Other trials in Canada

About this study

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

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.

Conditions: Metabolism and Nutrition Disorder, Obesity, Obstructive Sleep Apnoea
Being tested: liraglutide, placebo
Keywords: OSA
Medical subject headings: Nutrition Disorders, Obesity, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01557166
Study group	Role	What they receive
Liraglutide 3.0 mg	Experimental	Not described Receives: Drug: liraglutide
Placebo	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 0, Week 32

Secondary outcomes (3)

Change From Baseline in Body Weight (kg)
Observed mean change from baseline in fasting body weight (kg) after 32 weeks of treatment.
Measured: Week 0, week 32
Change From Baseline in Fasting Plasma Glucose
Observed mean change from baseline in fasting plasma glucose (mmol/L) after 32 weeks of treatment.
Measured: Week 0, week 32
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)
Observed mean change from baseline in glycosylated haemoglobin (HbA1c) (%) after 32 weeks of treatment.
Measured: Week 0, week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 201217 Jun 2013

First posted19 Mar 2012 (estimated)
Study start7 Jun 2012
Primary completion1 Jun 2013
Study completion17 Jun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Metabolism and Nutrition DisorderStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 359 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01557166
Sponsor's protocol ID: NN8022-3970
Other IDs: U1111-1126-6260
Status last verified: Sep 2017
First submitted: 15 Mar 2012
Last updated: 1 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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 AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS. Endocr Pract. 2016 Nov;22(11):1277-1287. doi: 10.4158/EP151181.OR. Epub 2016 Aug 2.
PubMed 27482610
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.
PubMed 27817208
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. Int J Obes (Lond). 2016 Aug;40(8):1310-9. doi: 10.1038/ijo.2016.52. Epub 2016 Mar 23.
PubMed 27005405
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 Pooled Data From the SCALE Clinical Development Program. Diabetes Care. 2017 Jul;40(7):839-848. doi: 10.2337/dc16-2684. Epub 2017 May 4.
PubMed 28473337
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 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21.
PubMed 28386912
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 obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1.
PubMed 28950422

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01557166
Acronym / sponsor ID: NN8022-3970
Conditions: Metabolism and Nutrition Disorder, Obesity, Obstructive Sleep Apnoea
Keywords: OSA
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 359 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 7 Jun 2012 (actual)
Primary completion: 1 Jun 2013 (actual)
Study completion: 17 Jun 2013 (actual)
First posted: 19 Mar 2012 (estimated)
Results: Posted 9 Feb 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Liraglutide 3.0 mg	Experimental	Drug: liraglutide
Placebo	Placebo comparator	Drug: placebo

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
liraglutide3.0 mg liraglutide administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise	Drug	Liraglutide 3.0 mg
placeboPlacebo administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise	Drug	Placebo

Primary outcome

Change From Baseline in Apnoea-hypopnoea Index (AHI)
Time frame: Week 0, Week 32
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.

3 secondary outcomes

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

Results and safety

Results posted to the registry on 9 Feb 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liraglutide 3.0 mg	180	134
Placebo	179	142

Primary outcome: Change From Baseline in Apnoea-hypopnoea Index (AHI)

Time frame: Week 0, Week 32. Mean (Standard Deviation). Unit: events/hour

Measure	Liraglutide 3.0 mg n = 168	Placebo n = 166
Value	-12.22 (23.34)	-6.08 (25.90)

Liraglutide 3.0 mg vs Placebo: Estimated treatment difference: -6.10 (95% CI -11.0 to -1.19), p = 0.015, ANCOVA

Population analysed: Full analysis set (FAS) - included all randomised subjects. 334 subjects contributed to the statistical analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Events that either occur before randomisation and increase in severity during the treatment period or have an onset date on or after the first day of randomised treatment and no later than 14 days after the last day of randomised treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liraglutide 3.0 mg	6 of 176 (3.4%)	117 of 176 (66.5%)	Not reported
Placebo	6 of 179 (3.4%)	84 of 179 (46.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27482610O'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 AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS. Endocr Pract. 2016 Nov;22(11):1277-1287. doi: 10.4158/EP151181.OR. Epub 2016 Aug 2.
Results publication: PubMed 27817208Bays 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.
Results publication: PubMed 27005405Blackman 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. Int J Obes (Lond). 2016 Aug;40(8):1310-9. doi: 10.1038/ijo.2016.52. Epub 2016 Mar 23.
Results publication: PubMed 28473337Steinberg 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 Pooled Data From the SCALE Clinical Development Program. Diabetes Care. 2017 Jul;40(7):839-848. doi: 10.2337/dc16-2684. Epub 2017 May 4.
Results publication: PubMed 28386912O'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 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21.
Results publication: PubMed 28950422Davies 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 obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1.
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

42 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing liraglutide in people with Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 42 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Apnoea-hypopnoea Index (AHI) (time frame: Week 0, Week 32). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01557166, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.