GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes

Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: A 56 Week Randomised, Double-blind, Placebo-controlled, Three Armed Parallel Group, Multi-centre, Multinational Trial With a 12 Week Observational Follow-up Period

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

161

Recruiting sites

—

Enrollment

846

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥27•HbA1c 7-10%

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 IDNCT01272232

Org study IDNN8022-1922

Secondary ID2008-002199-88

Secondary IDU1111-1118-7963WHO

Timeline

Milestones

Study first posted2011-01-07estimated

Study start2011-06-01actual

Primary completion2013-01-01actual

Study completion2013-01-25actual

Results first posted2015-02-09estimated

Last update posted2017-12-29actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Informed consent obtained

•Subjects diagnosed with type 2 diabetes and treated with either diet and exercise alone, metformin, sulphonylurea, glitazone as single agent therapy or a combination of the previously mentioned compounds

•HbA1c 7.0-10.0% (both inclusive)

•Body Mass Index (BMI) at least 27.0 kg/m^2

•Stable body weight

•Preceding failed dietary effort

Exclusion criteria

•Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months

•Known proliferative retinopathy or maculopathy

•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 above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)

•Screening calcitonin of 50 ng/L or above

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

•Personal history of non-familial medullary thyroid carcinoma

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

Safety / tolerability / PK

Weight & body composition

16 endpoints

Primary/registry result

Change (%) From Baseline in Body Weight (Fasting)

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	-5.9	—
Liraglutide 1.8 mg	-4.6	—
Liraglutide Placebo	-2.0	—

Treatment contrast-3.9795% CI-4.84 – -3.11p<0.0001ANCOVA

Treatment contrast-2.6295% CI-3.63 – -1.62p<0.0001ANCOVA

Treatment contrast-1.3595% CI-2.23 – -0.48p0.0024ANCOVA

Primary/registry result

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

Time frame:at 56 weeks

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of subjects	95% CI
Liraglutide 3.0 mgYes	49.9	—
No	50.1	—
Liraglutide 1.8 mgYes	35.6	—
No	64.4	—
Liraglutide PlaceboYes	13.8	—
No	86.2	—

Odds Ratio (OR)6.8195% CI4.34 – 10.68p<0.0001Regression, Logistic

Odds Ratio (OR)3.6995% CI2.24 – 6.09p<0.0001Regression, Logistic

Odds Ratio (OR)1.8495% CI1.29 – 2.64p0.0008Regression, Logistic

Primary/registry result

Proportion of Subjects Losing More Than 10% of Baseline 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 mgYes	23.4	—
No	76.6	—
Liraglutide 1.8 mgYes	14.4	—
No	85.6	—
Liraglutide PlaceboYes	4.3	—
No	95.7	—

Odds Ratio (OR)7.1095% CI3.48 – 14.48p<0.0001Regression, Logistic

Odds Ratio (OR)3.8495% CI1.75 – 8.41p0.0008Regression, Logistic

Odds Ratio (OR)1.8595% CI1.16 – 2.95p0.0099Regression, Logistic

Primary/protocol endpoint

Change (%) From Baseline in Body Weight (Fasting)

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 Body Weight

Time frame:at 56 weeks

≥5% weight-loss responders

threshold achievement, improvement

Primary/protocol endpoint

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

Time frame:at 56 weeks

≥10% weight-loss responders

threshold achievement, improvement

Secondary/registry result

Change From Baseline in Waist Circumference

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	-6.1	—
Liraglutide 1.8 mg	-4.8	—
Liraglutide Placebo	-2.7	—

Treatment contrast-3.2295% CI-4.20 – -2.23p<0.0001ANCOVA

Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.

Treatment contrast-2.0695% CI-3.20 – -0.92p0.0004ANCOVA

Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.

Treatment contrast-1.1695% CI-2.16 – -0.16p0.0224ANCOVA

Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.

Secondary/registry result

Change (%) From Baseline in Body Weight (Fasting)

Time frame:Week 0, week 68

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change	95% CI
Liraglutide 3.0 mg	-4.7	—
Liraglutide 1.8 mg	-3.6	—
Liraglutide Placebo	-2.7	—

Treatment contrast-2.1795% CI-3.32 – -1.02p0.0002ANCOVA

Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.

Treatment contrast-1.2095% CI-2.51 – 0.11p0.0725ANCOVA

Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.

Treatment contrast-0.9795% CI-2.02 – 0.09p0.0717ANCOVA

Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.

Secondary/registry result

Change (%) From Week 56 to 68 in Body Weight (Fasting)

Time frame:Week 56, week 68

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), percent change	95% CI
Liraglutide 3.0 mg	2.3	—
Liraglutide 1.8 mg	2.0	—
Liraglutide Placebo	-0.1	—

Secondary/registry result

Change From Baseline in Waist Circumference

Time frame:Week 0, week 68

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
Liraglutide 3.0 mg	-5.7	—
Liraglutide 1.8 mg	-4.4	—
Liraglutide Placebo	-3.2	—

Treatment contrast-2.4995% CI-3.75 – -1.24p<0.0001ANCOVA

Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.

Treatment contrast-1.4795% CI-2.92 – -0.03p0.0457ANCOVA

Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.

Treatment contrast-1.0295% CI-2.22 – 0.18p0.0961ANCOVA

Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.

Secondary/registry result

Change From Week 56 to 68 in Waist Circumference

Time frame:Week 56, week 68

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), cm	95% CI
Liraglutide 3.0 mg	1.21	—
Liraglutide 1.8 mg	1.02	—
Liraglutide Placebo	-0.22	—

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:Week 0, week 56

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change (%) From Baseline in Body Weight (Fasting)

Time frame:Week 0, week 68

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change (%) From Week 56 to 68 in Body Weight (Fasting)

Time frame:Week 56, week 68

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:Week 0, week 68

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Week 56 to 68 in Waist Circumference

Time frame:Week 56, week 68

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Secondary/registry result

Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)

Time frame:Week 0, week 56

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage point change of HbA1c	95% CI
Liraglutide 3.0 mg	-1.3	—
Liraglutide 1.8 mg	-1.1	—
Liraglutide Placebo	-0.3	—

Treatment contrast-0.9395% CI-1.08 – -0.78p<0.0001ANCOVA

Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.

Treatment contrast-0.7495% CI-0.91 – -0.57p<0.0001ANCOVA

Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.

Treatment contrast-0.1995% CI-0.34 – -0.04p0.0125ANCOVA

Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.

Secondary/registry result

Proportion of Subjects Reaching Target HbA1c Below 7%

Time frame:at 56 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Liraglutide 3.0 mgYes	69.2	—
No	30.8	—
Liraglutide 1.8 mgYes	66.7	—
No	33.3	—
Liraglutide PlaceboYes	27.2	—
No	72.8	—

Odds Ratio (OR)8.7995% CI5.74 – 13.4p<0.0001Regression, Logistic

Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.

Odds Ratio (OR)7.7195% CI4.76 – 12.51p<0.0001Regression, Logistic

Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.

Odds Ratio (OR)1.1495% CI0.76 – 1.71p0.5319Regression, Logistic

Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.

Secondary/registry result

Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%

Time frame:at 56 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of subjects	95% CI
Liraglutide 3.0 mgYes	56.5	—
No	43.5	—
Liraglutide 1.8 mgYes	45.6	—
No	54.4	—
Liraglutide PlaceboYes	15.0	—
No	85.0	—

Odds Ratio (OR)9.6195% CI6.05 – 15.26p<0.0001Regression, Logistic

Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.

Odds Ratio (OR)5.9895% CI3.59 – 9.97p<0.0001Regression, Logistic

Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.

Odds Ratio (OR)1.6195% CI1.10 – 2.34p0.0142Regression, Logistic

Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.

Secondary/protocol endpoint

Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)

Time frame:Week 0, week 56

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of Subjects Reaching Target HbA1c Below 7%

Time frame:at 56 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%

Time frame:at 56 weeks

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Incidence of Hypoglycaemic Episodes

Time frame:Weeks 0-56

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Episodes/100 years of patient exposure	95% CI
Liraglutide 3.0 mgMinor	34	—
ADA: Severe	1	—
ADA: Documented, symptomatic	87	—
ADA: Asymptomatic	151	—
ADA: Probable, symptomatic	2	—
ADA: Relative	17	—
ADA: Unclassifiable	14	—
Liraglutide 1.8 mgMinor	46	—
ADA: Severe	2	—
ADA: Documented, symptomatic	95	—
ADA: Asymptomatic	142	—
ADA: Probable, symptomatic	2	—
ADA: Relative	16	—
ADA: Unclassifiable	7	—
Liraglutide PlaceboMinor	13	—
ADA: Severe	0	—
ADA: Documented, symptomatic	31	—
ADA: Asymptomatic	46	—
ADA: Probable, symptomatic	1	—
ADA: Relative	5	—
ADA: Unclassifiable	3	—

Secondary/protocol endpoint

Incidence of Hypoglycaemic Episodes

Time frame:Weeks 0-56

Documented hypoglycemia

event count, event

Publications (13)

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
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
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 background
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
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
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
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
Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes: The SCALE Diabetes Randomized Clinical Trial.
JAMA2015 Aug 18PMID26284720doi:10.1001/jama.2015.9676via 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.