GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT00781937

CompletedPhase 3Results posted

Comparison of Liraglutide Versus Placebo in Weight Loss Maintenance in Obese Subjects: SCALE - Maintenance

Effect of Liraglutide on Long-term Weight Maintenance and Additional Weight Loss Induced by a 4 to 12 Week Low Calorie Diet in Obese Subjects; A 56 Week Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Trial With a 12 Week Follow-up Period

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

422

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI 27-30

Primary endpoints

•Body weight, % change•Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss•≥5% 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 IDNCT00781937

Org study IDNN8022-1923

Timeline

Milestones

Study first posted2008-10-29estimated

Study start2008-10-30actual

Primary completion2010-09-01actual

Study completion2010-09-01actual

Results first posted2011-11-28estimated

Last update posted2017-11-01actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Body Mass Index (BMI) of either 30 kg/m^2 or more or BMI of less than 30 kg/m^2 to 27 kg/m^2 with presence of co-morbidities

•Stable body weight during the previous 3 months (less than 5 kg self-reported weight change)

•Previously undergone dietary weight loss and was not able to maintain reduced weight

Exclusion criteria

•Diagnosis of type 1 or type 2 diabetes

•Previous treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (including liraglutide or exenatide), within the last 3 months

•Visit 1 thryoid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L

•History of chronic pancreatitis or idiopathic acute pancreatitis

•Obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome)

•Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial

•Current participation in an organized diet reduction program (or within the last 3 months)

•Currently using or have used within three months before this trial: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phenteremine, or metformin

•Previous surgical treatment for obesity (excluding liposuction if performed more than one year before trial entry)

•History of major depressive disorder or a PHQ-9 (Patient Health Questionnaire-9) score of more than 15 within the last 2 years or history of other severe psychiatric disorders or diagnosis of an eating disorder

•Subjects with a lifetime history of a suicide attempt or history of any suicidal behavior within the past month before entry into the trial

Endpoints (52)

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

Cardiometabolic biomarkers

Glycemic / diabetes

Patient-reported / QoL

Other clinical outcomes

Other (unclassified)

Weight & body composition

24 endpoints

Primary/registry result

Mean Percentage Change in Fasting Body Weight From Baseline

Time frame:Week 0, week 56

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage	95% CI
Lira 3.0 mg	-6.11	—
Placebo	-0.05	—

Treatment Contrast-6.0695% CI-7.50 – -4.62p<0.0001ANCOVA

Primary/registry result

Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0

Time frame:Week 0, week 56

threshold achievement, improvement

Posted result

Group	Value (number), percentage of subjects	95% CI
Lira 3.0 mg	80.8	—
Placebo	47.9	—

Odds Ratio (OR)4.8295% CI3.01 – 7.71p<0.0001Regression, Logistic

Primary/registry result

Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0

Time frame:Week 0, week 56

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of subjects	95% CI
Lira 3.0 mg	50.5	—
Placebo	21.9	—

Odds Ratio (OR)3.8695% CI2.44 – 6.09p<0.0001Regression, Logistic

Primary/protocol endpoint

Mean Percentage Change in Fasting Body Weight From Baseline

Time frame:Week 0, week 56

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0

Time frame:Week 0, week 56

threshold achievement, improvement

Primary/protocol endpoint

Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0

Time frame:Week 0, week 56

≥5% weight-loss responders

threshold achievement, improvement

Secondary/registry result

Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0

Time frame:Week 0, week 56

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of subjects	95% CI
Lira 3.0 mg	26.1	—
Placebo	6.3	—

Odds Ratio (OR)5.3095% CI2.79 – 10.08p<0.0001Regression, Logistic

Secondary/registry result

Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0

Time frame:Week 0, week 56

threshold achievement, event

Posted result

Group	Value (number), percentage of subjects	95% CI
Lira 3.0 mg	1.9	—
Placebo	17.5	—

Odds Ratio (OR)0.0995% CI0.03 – 0.26p<0.0001Regression, Logistic

Secondary/registry result

Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0

Time frame:Week 0, week 56

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of subjects	95% CI
Lira 3.0 mg	0	—
Placebo	2.9	—

Secondary/registry result

Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0

Time frame:Week 0, week 56

threshold achievement, improvement

Posted result

Group	Value (number), percentage of subjects	95% CI
Lira 3.0 mg	93.2	—
Placebo	70.9	—

Odds Ratio (OR)5.8695% CI3.12 – 10.98p<0.0001Regression, Logistic

Secondary/registry result/low confidence

Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0

Time frame:Week 0, week 56

threshold achievement, improvement

Posted result

Group	Value (number), percentage of subjects	95% CI
Lira 3.0 mg	87.4	—
Placebo	54.4	—

Odds Ratio (OR)6.0295% CI3.65 – 9.92p<0.0001Regression, Logistic

Secondary/registry result

Change From Baseline in Fasting Weight

Time frame:Week 0, week 56

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Lira 3.0 mg	-5.7	—
Placebo	0.16	—

Treatment Contrast-5.8695% CI-7.30 – -4.43p<0.0001ANCOVA

Secondary/registry result

Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period

Time frame:Week 0, week 68

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Lira 3.0 mg	-3.83	—
Placebo	0.41	—

Treatment Contrast-4.2395% CI-6.04 – -2.43p<0.0001ANCOVA

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 (least_squares_mean), cm	95% CI
Lira 3.0 mg	-4.36	—
Placebo	-0.86	—

Treatment Contrast-3.5095% CI-4.84 – -2.15p<0.0001ANCOVA

Secondary/registry result

Change From Baseline in Body Mass Index (BMI)

Time frame:Week 0, week 56

BMI, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg/m^2	95% CI
Lira 3.0 mg	-1.90	—
Placebo	0.15	—

Treatment Contrast-2.0595% CI-2.53 – -1.57p<0.0001ANCOVA

Secondary/protocol endpoint

Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0

Time frame:Week 0, week 56

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0

Time frame:Week 0, week 56

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0

Time frame:Week 0, week 56

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0

Time frame:Week 0, week 56

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0

Time frame:Week 0, week 56

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Fasting Weight

Time frame:Week 0, week 56

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period

Time frame:Week 0, week 68

Body weight, absolute change (kg)

change from baseline, improvement

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 Mass Index (BMI)

Time frame:Week 0, week 56

BMI, change

change from baseline, improvement

Glycemic / diabetes

10 endpoints

Secondary/registry result

Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)

Time frame:Week 0, week 56

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percent change	95% CI
Lira 3.0 mg	8.51	—
Placebo	6.16	—

Treatment Contrast2.3595% CI-2.79 – 7.49p0.3689ANCOVA

Secondary/registry result

Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)

Time frame:Week 0, week 56

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), proportion	95% CI
Lira 3.0 mg	-0.01	—
Placebo	0.08	—

Treatment Contrast-0.1095% CI-0.16 – -0.03p0.0053ANCOVA

Secondary/registry result

Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 56

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 3.0 mg	-0.52	—
Placebo	-0.14	—

Treatment Contrast-0.3895% CI-0.50 – -0.26p<0.0001ANCOVA

Secondary/registry result/low confidence

Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin

Time frame:Week 0, week 56

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pmol/L	95% CI
Lira 3.0 mg	0.50	—
Placebo	2.35	—

Treatment Contrast-1.8595% CI-3.34 – -0.37p0.0147ANCOVA

Secondary/registry result

Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)

Time frame:Week 0, week 56

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage point	95% CI
Lira 3.0 mg	-0.14	—
Placebo	0.13	—

Treatment Contrast-0.2795% CI-0.33 – -0.21p<0.0001ANCOVA

Secondary/protocol endpoint

Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)

Time frame:Week 0, week 56

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)

Time frame:Week 0, week 56

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)

Time frame:Week 0, week 56

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin

Time frame:Week 0, week 56

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)

Time frame:Week 0, week 56

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

13 endpoints

Secondary/registry result

Change From Baseline in Blood Pressure

Time frame:Week 0, week 56

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
Lira 3.0 mgChange in Systolic Blood Pressure	1.31	—
Change in Diastolic Blood Pressure	1.81	—
PlaceboChange in Systolic Blood Pressure	4.03	—
Change in Diastolic Blood Pressure	2.15	—

Treatment Contrast-2.7295% CI-4.69 – -0.76p0.0068ANCOVA

Analysis is of treatment contrast, change in systolic blood pressure.

Treatment Contrast-0.3495% CI-1.74 – 1.07p0.6386ANCOVA

Analysis is of treatment contrast, change in diastolic blood pressure.

Secondary/registry result

Change From Baseline in Pulse

Time frame:Week 0, week 56

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), beats/minute	95% CI
Lira 3.0 mg	4.12	—
Placebo	3.15	—

Treatment Contrast0.9795% CI-0.51 – 2.45p0.1968ANCOVA

Secondary/registry result

Change From Baseline in Fasting Lipid Profile: Triglycerides

Time frame:Week 0, week 56

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 3.0 mg	0.02	—
Placebo	0.12	—

Treatment Contrast-0.1195% CI-0.20 – -0.01p0.0310ANCOVA

Secondary/registry result

Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol

Time frame:Week 0, week 56

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 3.0 mg	0.24	—
Placebo	0.33	—

Treatment Contrast-0.0995% CI-0.20 – 0.02p0.1098ANCOVA

Secondary/registry result

Change From Baseline in Fasting Lipid Profile: Total Cholesterol

Time frame:Week 0, week 56

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
Lira 3.0 mg	0.22	—
Placebo	0.33	—

Treatment Contrast-0.1195% CI-0.24 – 0.03p0.1149ANCOVA

Secondary/registry result

Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)

Time frame:Week 0, week 56

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Posted result

Group	Value (least_squares_mean), nmol/L	95% CI
Lira 3.0 mg	-11.31	—
Placebo	1.70	—

Treatment Contrast-13.0195% CI-23.40 – -2.64p0.0141ANCOVA

Secondary/registry result

Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56

Time frame:Week 56

threshold achievement, improvement

Posted result

Group	Value (number), percentage of subjects	95% CI
Lira 3.0 mg	31.4	—
Placebo	36.7	—

Odds Ratio (OR)0.6495% CI0.36 – 1.12p0.1199Regression, Logistic

Secondary/protocol endpoint

Change From Baseline in Blood Pressure

Time frame:Week 0, week 56

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Pulse

Time frame:Week 0, week 56

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Fasting Lipid Profile: Triglycerides

Time frame:Week 0, week 56

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol

Time frame:Week 0, week 56

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change From Baseline in Fasting Lipid Profile: Total Cholesterol

Time frame:Week 0, week 56

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)

Time frame:Week 0, week 56

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Patient-reported / QoL

2 endpoints

Secondary/registry result

Binge Eating Scale Scores by Week and Severity

Time frame:Week 0, week 50 and week 57

descriptive, improvement

Posted result

Group	Value (mean), scores on a scale	95% CI
Lira 3.0 mgWeek 0, baseline	7.8	—
Week 50	6.6	—
Week 57	6.6	—
PlaceboWeek 0, baseline	7.8	—
Week 50	8.6	—
Week 57	6.9	—

Secondary/protocol endpoint

Binge Eating Scale Scores by Week and Severity

Time frame:Week 0, week 50 and week 57

descriptive, improvement

Other clinical outcomes

2 endpoints

Secondary/registry result

Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications)

Time frame:Week 0 and week 56

descriptive

Posted result

Group	Value (number), Subjects	95% CI
Lira 3.0 mgAntihypertensive drug - Week 0	65	—
Antihypertensive drug - Week 56	63	—
Antipsychotic drug - Week 0	18	—
Antipsychotic drug - Week 56	20	—
Lipid lowering drug - Week 0	45	—
Lipid lowering drug - Week 56	52	—
PlaceboAntihypertensive drug - Week 0	66	—
Antihypertensive drug - Week 56	63	—
Antipsychotic drug - Week 0	25	—
Antipsychotic drug - Week 56	29	—
Lipid lowering drug - Week 0	45	—
Lipid lowering drug - Week 56	50	—

Secondary/protocol endpoint

Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56

Time frame:Week 56

threshold achievement, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications)

Time frame:Week 0 and week 56

descriptive

Publications (7)

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
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
Missing data in clinical trials for weight management.
Journal of biopharmaceutical statistics2016 (year)PMID26418188doi:10.1080/10543406.2015.1094814via CT.gov reference
Weight maintenance and additional weight loss with liraglutide after low-calorie-diet-induced weight loss: the SCALE Maintenance randomized study.
International journal of obesity (2005)2013 Nov (month)PMID23812094doi:10.1038/ijo.2013.120via 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.