GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes

Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Trial With Stratification of Subject to Either 56 or 160 Weeks of Treatment Based on Pre-diabetes Status at Randomisation

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

226

Recruiting sites

—

Enrollment

3,731

actual

Study population

Obesity / overweight, Prediabetes / glucose intolerance

Key I/E criterion

—

Primary endpoints

•Body weight, % change•≥5% weight-loss responders•≥10% weight-loss responders

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 IDNCT01272219

Org study IDNN8022-1839

Secondary ID2008-001049-24

Secondary IDU1111-1118-7871WHO

Timeline

Milestones

Study first posted2011-01-07estimated

Study start2011-06-01actual

Primary completion2013-03-18actual

Results first posted2015-02-09estimated

Study completion2015-03-02actual

Last update posted2018-01-19actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightPrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Informed consent obtained

•Body Mass Index (BMI) of 30.0 kg/m^2 or above

•Body Mass Index (BMI) of 27 kg/m^2 or above in the presence of co-morbidities of treated or untreated dyslipidemia and/or hypertension

•Stable body weight

•Preceding failed dietary effort

Exclusion criteria

•Known type 1 or type 2 diabetes

•Glycosylated haemoglobin (HbA1c) of 6.5 % or above (Screening visit 1) or FPG of 126 mg/dL (7 mmol/L) or above (Screening visit 2) or 2 hour post-challenge (OGTT) plasma glucose of 200 mg/dL (11.1 mmol/L) or above (Screening visit 2)

•Screening calcitonin of 50 ng/L or above

•Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)

•Personal history of non-familial medullary thyroid carcinoma

•History of acute or chronic pancreatitis

•Obesity induced by drug treatment

•Use of approved weight lowering pharmacotherapy

•Previous surgical treatment of obesity

•History of major depressive disorder or suicide attempt

•Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)

Endpoints (24)

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

Weight & body composition

Glycemic / diabetes

Weight & body composition

18 endpoints

Primary/registry result

Change From Baseline in Fasting Body Weight

Time frame:Week 0, Week 56

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change	95% CI
Liraglutide 3.0 mg (56-Week)	-7.98	—
Liraglutide Placebo (56-Week)	-2.62	—

Estimated mean difference-5.3995% CI-5.82 – -4.95p<0.0001ANCOVA

Primary/registry result

Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.

Time frame:At Week 56

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of subjects	95% CI
Liraglutide 3.0 mg (56-Week)	63.2	—
Liraglutide Placebo (56-Week)	27.1	—

Odds Ratio (OR)4.8095% CI4.12 – 5.60p<0.0001Regression, Logistic

Primary/registry result

Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight

Time frame:At 56 weeks

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of subjects	95% CI
Liraglutide 3.0 mg (56-Week)	33.1	—
Liraglutide Placebo (56-Week)	10.6	—

Odds Ratio (OR)4.3495% CI3.54 – 5.32p<0.0001Regression, Logistic

Primary/protocol endpoint

Change From Baseline in Fasting Body Weight

Time frame:Week 0, Week 56

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.

Time frame:At Week 56

≥5% weight-loss responders

threshold achievement, improvement

Primary/protocol endpoint

Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight

Time frame:At 56 weeks

≥10% weight-loss responders

threshold achievement, improvement

Secondary/registry result

Change From Baseline in Waist Circumference (cm)

Time frame:Week 0, Week 56

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
Liraglutide 3.0 mg (56-Week)	-8.19	—
Liraglutide Placebo (56-Week)	-3.94	—

Secondary/registry result

Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)

Time frame:Week 0, week 160

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
Liraglutide 3.0 mg (160-Week)	-6.87	—
Liraglutide Placebo (160-Week)	-3.37	—

Secondary/registry result

Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)

Time frame:Week 0, week 160

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change	95% CI
Liraglutide 3.0 mg (160-Week)	-6.14	—
Liraglutide Placebo (160-Week)	-1.89	—

Secondary/registry result

Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline)

Time frame:At 160 weeks

threshold achievement, improvement

components≥5% weight-loss responders, ≥10% weight-loss responders

Posted result

Group	Value (number), percentage of subjects	95% CI
Liraglutide 3.0 mg (160-Week)Losing >=5% of baseline body weight	49.6	—
Losing >10% of baseline body weight	24.8	—
Liraglutide Placebo (160-Week)Losing >=5% of baseline body weight	23.7	—
Losing >10% of baseline body weight	9.9	—

Secondary/registry result

Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)

Time frame:Week 56, Week 68

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change	95% CI
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)	0.69	—
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)	2.91	—
Liraglutide Placebo, no Pre-diabetes	0.28	—

Secondary/registry result

Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)

Time frame:Week 0, Week 68

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change	95% CI
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)	-8.44	—
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)	-6.77	—
Liraglutide Placebo, no Pre-diabetes	-3.11	—

Secondary/protocol endpoint

Change From Baseline in Waist Circumference (cm)

Time frame:Week 0, Week 56

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)

Time frame:Week 0, week 160

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)

Time frame:Week 0, week 160

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline)

Time frame:At 160 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)

Time frame:Week 56, Week 68

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)

Time frame:Week 0, Week 68

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

6 endpoints

Primary/registry result

Proportion of Subjects With Onset of Type 2 Diabetes

Time frame:At 160 weeks

Time to T2DM onset

time to event, event

Posted result

Group	Value (number), Subject	95% CI
Liraglutide 3.0 mg (160-Week)	26	—
Liraglutide Placebo (160-Week)	46	—

Treatment estimate2.68195% CI1.856 – 3.872p<.0001Weibull analysis

Primary/protocol endpoint

Proportion of Subjects With Onset of Type 2 Diabetes

Time frame:At 160 weeks

Time to T2DM onset

time to event, event

Secondary/registry result/low confidence

Pre-diabetes Status After 56 Weeks of Treatment

Time frame:Week 0, Week 56

categorical status, improvement

Posted result

Group	Value (number), percentage of subjects	95% CI
Liraglutide 3.0 mg (56-Week)With No Pre-diabetes	78.3	—
With Pre-diabetes	20.6	—
With Transient Type 2 Diabetes	0.9	—
With Confirmed Type 2 Diabetes	0.2	—
Liraglutide Placebo (56-Week)With No Pre-diabetes	50.9	—
With Pre-diabetes	46.1	—
With Transient Type 2 Diabetes	1.8	—
With Confirmed Type 2 Diabetes	1.1	—

Secondary/registry result/low confidence

Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment

Time frame:Week 0, week 160

categorical status, improvement

Posted result

Group	Value (number), percentage of subjects	95% CI
Liraglutide 3.0 mg (160-Week)With No Pre-diabetes	65.9	—
With Pre-diabetes	31.3	—
With Transient Type 2 Diabetes	1.1	—
With Confirmed Type 2 Diabetes	1.8	—
Liraglutide Placebo (160-Week)With No Pre-diabetes	36.3	—
With Pre-diabetes	54.9	—
With Transient Type 2 Diabetes	2.6	—
With Confirmed Type 2 Diabetes	6.2	—

Secondary/protocol endpoint

Pre-diabetes Status After 56 Weeks of Treatment

Time frame:Week 0, Week 56

categorical status, improvement

Secondary/protocol endpoint/low confidence

Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment

Time frame:Week 0, week 160

categorical status, improvement

Publications (17)

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

The Correlation Between Body Mass Index and Health-Related Quality of Life: Data from Two Weight Loss Intervention Studies.
Advances in therapy2024 Nov (month)PMID39316288doi:10.1007/s12325-024-02932-8via clinicaltrials gov reference derived + pubmed nct search
Glucagon-like Peptide-1 Receptor Analogues for the Treatment of Obesity.
TouchREVIEWS in endocrinology2022 Mar (month)PMID35975210doi:10.17925/EE.2022.18.1.43via clinicaltrials gov reference derived + pubmed nct search
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
Improvements in health-related quality of life over 3 years with liraglutide 3.0 mg compared with placebo in participants with overweight or obesity.
Clinical obesity2018 Feb (month)PMID29045079doi:10.1111/cob.12226via 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
Effect of weight reductions on estimated kidney function: Post-hoc analysis of two randomized trials.
Journal of diabetes and its complications2017 Jul (month)PMID28462892doi:10.1016/j.jdiacomp.2017.04.003via CT.gov reference + pubmed nct search
3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial.
Lancet (London, England)2017 Apr 8PMID28237263doi:10.1016/S0140-6736(17)30069-7via CT.gov reference + pubmed nct search
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
Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m²: A Post-hoc Analysis.
Obesity facts2017 (year)PMID29145215doi:10.1159/000478099via CT.gov reference
Early Weight Loss with Liraglutide 3.0 mg Predicts 1-Year Weight Loss and is Associated with Improvements in Clinical Markers.
Obesity (Silver Spring, Md.)2016 Nov (month)PMID27804269doi:10.1002/oby.21629via 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
Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis.
Clinical pharmacokinetics2016 Nov (month)PMID27193270doi:10.1007/s40262-016-0410-7via CT.gov reference
Improvements in health-related quality of life with liraglutide 3.0 mg compared with placebo in weight management.
Clinical obesity2016 Aug (month)PMID27198973doi:10.1111/cob.12146via CT.gov reference
Exposure-response analyses of liraglutide 3.0 mg for weight management.
Diabetes, obesity & metabolism2016 May (month)PMID26833744doi:10.1111/dom.12639via CT.gov reference
Efficacy and safety of liraglutide 3.0 mg for weight management are similar across races: subgroup analysis across the SCALE and phase II randomized trials.
Diabetes, obesity & metabolism2016 Apr (month)PMID26744025doi:10.1111/dom.12632via CT.gov reference
Missing data in clinical trials for weight management.
Journal of biopharmaceutical statistics2016 (year)PMID26418188doi:10.1080/10543406.2015.1094814via CT.gov reference
A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management.
The New England journal of medicine2015 Jul 2PMID26132939doi:10.1056/NEJMoa1411892via 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.