GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

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

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

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

359

actual

Study population

Obesity / overweight, Sleep apnea

Key I/E criterion

•BMI ≥30

Primary endpoint

•AHI, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01557166

Org study IDNN8022-3970

Secondary IDU1111-1126-6260WHO

Timeline

Milestones

Study first posted2012-03-19estimated

Study start2012-06-07actual

Primary completion2013-06-01actual

Study completion2013-06-17actual

Results first posted2015-02-09estimated

Last update posted2017-11-01actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightSleep apnea

Eligibility

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Other clinical outcomes

Weight & body composition

2 endpoints

Secondary/registry result

Change From Baseline in Body Weight (kg)

Time frame:Week 0, week 32

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Liraglutide 3.0 mg	-6.73	—
Placebo	-1.87	—

Secondary/protocol endpoint

Change From Baseline in Body Weight (kg)

Time frame:Week 0, week 32

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Secondary/registry result

Change From Baseline in Fasting Plasma Glucose

Time frame:Week 0, week 32

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 3.0 mg	-0.15	—
Placebo	0.17	—

Secondary/registry result

Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)

Time frame:Week 0, week 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage of glycosylated haemoglobin	95% CI
Liraglutide 3.0 mg	-0.36	—
Placebo	-0.17	—

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose

Time frame:Week 0, week 32

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)

Time frame:Week 0, week 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Other clinical outcomes

2 endpoints

Primary/registry result

Change From Baseline in Apnoea-hypopnoea Index (AHI)

Time frame:Week 0, Week 32

AHI, change

change from baseline, improvement

Posted result

Group	Value (mean), events/hour	95% CI
Liraglutide 3.0 mg	-12.22	—
Placebo	-6.08	—

Estimated treatment difference-6.1095% CI-11.0 – -1.19p0.015ANCOVA

Primary/protocol endpoint

Change From Baseline in Apnoea-hypopnoea Index (AHI)

Time frame:Week 0, Week 32

AHI, change

change from baseline, improvement

Publications (6)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials.
Diabetes, obesity & metabolism2018 Mar (month)PMID28950422doi:10.1111/dom.13125via CT.gov reference
Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials.
Diabetes, obesity & metabolism2017 Nov (month)PMID28386912doi:10.1111/dom.12963via CT.gov reference
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 care2017 Jul (month)PMID28473337doi:10.2337/dc16-2684via CT.gov reference
Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects.
Current medical research and opinion2017 Feb (month)PMID27817208doi:10.1080/03007995.2016.1251892via CT.gov reference + pubmed nct search
EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS.
Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2016 Nov (month)PMID27482610doi:10.4158/EP151181.ORvia CT.gov reference
Effect of liraglutide 3.0 mg in individuals with obesity and moderate or severe obstructive sleep apnea: the SCALE Sleep Apnea randomized clinical trial.
International journal of obesity (2005)2016 Aug (month)PMID27005405doi:10.1038/ijo.2016.52via CT.gov reference + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.