SCALE™ IBT

CompletedPhase 3Results posted

Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

282

actual

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoints

•Body weight, % change•≥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 IDNCT02963935

Org study IDNN8022-4274

Secondary IDU1111-1177-5059World Health Organization (WHO)

Timeline

Milestones

Study first posted2016-11-15estimated

Study start2017-02-06actual

Primary completion2018-05-23actual

Study completion2018-06-19actual

Results first posted2019-07-30actual

Last update posted2020-03-11actual

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

•Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial

•BMI above or equal to 30 kg/m^2

•Male or female, age 18 years or older at the time of signing informed consent

Exclusion criteria

•HbA1c (glycosylated haemoglobin) above or equal to 6.5% (at screening visit), or diagnosis of type 1 or type 2 diabetes mellitus

•Recent history of cardiovascular disease (myocardial infarction or stroke within the past 6 months), severe congestive heart failure (NYHA class III, IV), or second degree or greater heart block

•Personal or family history of Medullary Thyroid Carcinoma (MTC), or Multiple Endocrine Neoplasia type 2 (MEN2)

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)

•Use in past 90 days of medications known to induce significant weight loss (e.g., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics)

•History of pancreatitis (acute or chronic)

•History of major depressive disorder within the past 2 years

•Any lifetime history of a suicide attempt

•Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic above or equal to 180 mmHg or diastolic above or equal to 110 mmHg)

•History of malignancy (except for non-melanoma skin cancer) within the past 5 years

Endpoints (102)

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

Patient-reported / QoL

Safety / tolerability / PK

Cardiometabolic biomarkers

Weight & body composition

Other clinical outcomes

Glycemic / diabetes

Other (unclassified)

Heart failure

Renal / kidney

Weight & body composition

12 endpoints

Primary/registry result

Change in 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 mgIn-trial observation period	-7.4	—
On-drug observation period	-9.1	—
PlaceboIn-trial observation period	-4.0	—
On-drug observation period	-4.8	—

Treatment difference-3.4595% CI-5.31 – -1.59p0.0003ANCOVA

Treatment difference-4.5995% CI-6.54 – -2.64p0.0000Mixed models repeated measurement (MMRM)

Primary/registry result

Proportion of Subjects Losing at Least 5% of Baseline Body Weight at Week 56

Time frame:Week 56

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
Liraglutide 3.0 mgIn-trial observation period	61.47	—
On-drug observation period	64.08	—
PlaceboIn-trial observation period	38.82	—
On-drug observation period	38.57	—

Odds Ratio (OR)2.5195% CI1.53 – 4.14p0.0003Regression, Logistic

Odds Ratio (OR)2.8495% CI1.75 – 4.61p0.0000Mixed models repeated measurement (MMRM)

Primary/protocol endpoint

Change in 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 Body Weight at Week 56

Time frame:Week 56

≥5% weight-loss responders

threshold achievement, improvement

Secondary/registry result

Proportion of Subjects Losing More Than 10% of Baseline Body Weight at Week 56

Time frame:Week 56

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
Liraglutide 3.0 mgIn-trial observation period	30.45	—
On-drug observation period	33.80	—
PlaceboIn-trial observation period	19.75	—
On-drug observation period	19.29	—

Odds Ratio (OR)1.7895% CI1.01 – 3.14p0.0469Regression, Logistic

Odds Ratio (OR)2.1495% CI1.24 – 3.69p0.0063Mixed models repeated measurement (MMRM)

Secondary/registry result

Proportion of Subjects Losing More Than 15% of Baseline Body Weight at Week 56

Time frame:Week 56

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
Liraglutide 3.0 mgIn-trial observation period	18.11	—
On-drug observation period	20.42	—
PlaceboIn-trial observation period	8.92	—
On-drug observation period	8.57	—

Odds Ratio (OR)2.2695% CI1.08 – 4.74p0.0311Regression, Logistic

Odds Ratio (OR)2.7495% CI1.33 – 5.62p0.0060Mixed models repeated measurement (MMRM)

Secondary/registry result

Proportion of Subjects Losing 4% or More of Baseline Body Weight

Time frame:Week 16

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
Liraglutide 3.0 mg	78.73	—
Placebo	52.70	—

Odds Ratio (OR)3.3295% CI1.93 – 5.72p<0.0001Regression, Logistic

Secondary/registry result

Change 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 mgIn-trial observation period	-9.27	—
On-drug observation period	-10.46	—
PlaceboIn-trial observation period	-6.91	—
On-drug observation period	-7.24	—

treatment difference-2.7295% CI-4.68 – -0.77p0.0063ANCOVA

Treatment difference-3.4595% CI-5.62 – -1.28p0.0020Mixed model repeated measurements (MMRM)

Secondary/protocol endpoint

Proportion of Subjects Losing More Than 10% of Baseline Body Weight at Week 56

Time frame:Week 56

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of Subjects Losing More Than 15% of Baseline Body Weight at Week 56

Time frame:Week 56

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of Subjects Losing 4% or More of Baseline Body Weight

Time frame:Week 16

threshold achievement, improvement

Secondary/protocol endpoint

Change in Waist Circumference (cm)

Time frame:Week 0, week 56

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Secondary/registry result

Change From Baseline in HbA1c (%)

Time frame:Week 0, week 56

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), percentage	95% CI
Liraglutide 3.0 mg	-0.2	—
Placebo	-0.1	—

Secondary/registry result

Change From Baseline in FPG (mg/dL)

Time frame:Week 0, week 56

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mg/dL	95% CI
Liraglutide 3.0 mg	-4.04	—
Placebo	-0.28	—

Secondary/protocol endpoint

Change From Baseline in HbA1c (%)

Time frame:Week 0, week 56

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in FPG (mg/dL)

Time frame:Week 0, week 56

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Heart failure

2 endpoints

Secondary/registry result

Change in Six Minutes Walking Distance Test (6MWT)

Time frame:Week 0, week 56

6-minute walk distance

change from baseline, improvement

Posted result

Group	Value (mean), meter	95% CI
Liraglutide 3.0 mgIn-trial observation period	47	—
On-drug observation period	53	—
PlaceboIn-trial observation period	49	—
On-drug observation period	51	—

Treatment difference3.1295% CI-12.68 – 18.92p0.6986ANCOVA

Treatment difference7.6695% CI-9.15 – 24.48p0.3700Mixed model repeated measurements (MMRM)

Secondary/protocol endpoint

Change in Six Minutes Walking Distance Test (6MWT)

Time frame:Week 0, week 56

6-minute walk distance

change from baseline, improvement

Renal / kidney

2 endpoints

Secondary/registry result

Change in Laboratory Measurements: Biochemistry (Glomerular Filtration Rate, Serum)

Time frame:Week 0, week 56

eGFR, change

change from baseline, improvement

Posted result

Group	Value (mean), mL/min/1.73m^2	95% CI
Liraglutide 3.0 mg	2	—
Placebo	2	—

Secondary/protocol endpoint

Change in Laboratory Measurements: Biochemistry (Glomerular Filtration Rate, Serum)

Time frame:Week 0, week 56

eGFR, change

change from baseline, improvement

Cardiometabolic biomarkers

20 endpoints

Secondary/registry result

Change From Baseline sBP (mmHg)

Time frame:Week 0, week 56

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
Liraglutide 3.0 mg	-2	—
Placebo	-1	—

Secondary/registry result

Change From Baseline dBP (mmHg)

Time frame:Week 0, week 56

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (mean), mmHg	95% CI
Liraglutide 3.0 mg	-1	—
Placebo	-1	—

Secondary/registry result

Change From Baseline in Lipids -Total Cholesterol

Time frame:Week 0, week 56

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 3.0 mg	-0.01	—
Placebo	0.00	—

Secondary/registry result

Change From Baseline in Lipids - LDL Cholesterol

Time frame:Week 0, week 56

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 3.0 mg	-0.01	—
Placebo	-0.01	—

Secondary/registry result

Change From Baseline in Lipids - HDL Cholesterol

Time frame:Week 0, week 56

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 3.0 mg	0.06	—
Placebo	0.02	—

Secondary/registry result

Change From Baseline in Lipids - VLDL Cholesterol

Time frame:Week 0, week 56

VLDL, change

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 3.0 mg	-0.06	—
Placebo	-0.01	—

Secondary/registry result

Change From Baseline in Lipids - TG

Time frame:Week 0, week 56

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 3.0 mg	-0.19	—
Placebo	-0.01	—

Secondary/registry result

Change From Baseline in Lipids - FFA

Time frame:Week 0, week 56

Free fatty acids, change

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 3.0 mg	-0.07	—
Placebo	-0.06	—

Secondary/registry result

Change in Resting Pulse

Time frame:Week 0, week 56

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), beats/min	95% CI
Liraglutide 3.0 mg	2	—
Placebo	1	—

Secondary/registry result

Change in Laboratory Measurements: Biochemistry (C-reactive Protein and Uric Acid)

Time frame:Week 0, week 56

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Posted result

Group	Value (mean), mg/dL	95% CI
Liraglutide 3.0 mgHigh sensitive c-reactive protein	-2.51	—
Uric acid	-0.6	—
PlaceboHigh sensitive c-reactive protein	-0.85	—
Uric acid	-0.3	—

Secondary/protocol endpoint

Change From Baseline sBP (mmHg)

Time frame:Week 0, week 56

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change From Baseline dBP (mmHg)

Time frame:Week 0, week 56

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change From Baseline in Lipids -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 Lipids - 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 Lipids - HDL Cholesterol

Time frame:Week 0, week 56

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change From Baseline in Lipids - VLDL Cholesterol

Time frame:Week 0, week 56

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Lipids - TG

Time frame:Week 0, week 56

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change From Baseline in Lipids - FFA

Time frame:Week 0, week 56

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Resting Pulse

Time frame:Week 0, week 56

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Laboratory Measurements: Biochemistry (C-reactive Protein and Uric Acid)

Time frame:Week 0, week 56

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Patient-reported / QoL

26 endpoints

Secondary/registry result

Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score

Time frame:Week 0, week 56

SF-36 physical

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	95% CI
Liraglutide 3.0 mgIn-trial observation period	3.55	—
On-drug observation period	4.03	—
PlaceboIn-trial observation period	4.21	—
On-drug observation period	4.77	—

Treatment difference0.1695% CI-1.19 – 1.52p0.8137ANCOVA

Treatment difference0.1695% CI-1.12 – 1.43p0.8053Mixed model repeated measurements (MMRM)

Secondary/registry result

Change in IWQoL-Lite for CT, Physical Function Domain (5-items) Score

Time frame:Week 0, week 56

IWQOL-Lite physical

change from baseline, improvement

Posted result

Group	Value (mean), Scores on a scale	95% CI
Liraglutide 3.0 mgIn-trial observation period	13.5	—
On-drug observation period	15.2	—
PlaceboIn-trial observation period	15.5	—
On-drug observation period	17.5	—

Treatment difference0.8795% CI-3.41 – 5.14p0.6916ANCOVA

treatment difference1.2595% CI-2.95 – 5.45p0.5572Mixed models repeated measurements (MMRM

Secondary/registry result

Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains)

Time frame:Week 0, week 56

SF-36 total

change from baseline, improvement

Posted result

Group	Value (mean), scores on a scale	95% CI
Liraglutide 3.0 mgBodily Pain	0.67	—
General Health Perception	1.89	—
Mental Health	-0.93	—
Role Lim Emotion Prob	-1.27	—
Role Lim. Phy Health	2.01	—
Social Functioning	1.22	—
Vitality	2.64	—
PlaceboBodily Pain	1.21	—
General Health Perception	1.08	—
Mental Health	-0.68	—
Role Lim Emotion Prob	-2.21	—
Role Lim. Phy Health	2.11	—
Social Functioning	-0.45	—
Vitality	2.43	—

Secondary/registry result

Change in Short Form-36 v2.0 Acute (SF-36) (Physical Component Summary (PCS))

Time frame:Week 0, week 56

SF-36 physical

change from baseline, improvement

Posted result

Group	Value (mean), scores on a scale	95% CI
Liraglutide 3.0 mg	3.41	—
Placebo	3.83	—

Secondary/registry result

Change in Short Form-36 v2.0 Acute (SF-36) (Mental Component Summary (MCS)

Time frame:Week 0, week 56

SF-36 mental

change from baseline, improvement

Posted result

Group	Value (mean), scores on a scale	95% CI
Liraglutide 3.0 mg	-1.22	—
Placebo	-2.20	—

Secondary/registry result

Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Pain/Discomfort Domain Score

Time frame:Week 0, week 56

IWQOL-Lite physical

change from baseline, improvement

Posted result

Group	Value (mean), scores on a scale	95% CI
Liraglutide 3.0 mg	10.1	—
Placebo	8.6	—

Secondary/registry result

Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Psychosocial Domain Score

Time frame:Week 0, week 56

IWQOL-Lite total

change from baseline, improvement

Posted result

Group	Value (mean), score	95% CI
Liraglutide 3.0 mg	13.5	—
Placebo	12.4	—

Secondary/registry result

Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Total Score

Time frame:Week 0, week 56

IWQOL-Lite total

change from baseline, improvement

Posted result

Group	Value (mean), scores on a scale	95% CI
Liraglutide 3.0 mg	13.2	—
Placebo	12.8	—

Secondary/registry result

Change in Weight Related Sign and Symptom (WRSS) Measure, Total Score

Time frame:Week 0, week 56

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Liraglutide 3.0 mg	NA	—
Placebo	NA	—

Secondary/registry result

Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.3 T-score Points Increase From Baseline in SF-36 Physical Functioning Score

Time frame:Week 56

SF-36 physical

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants	95% CI
Liraglutide 3.0 mg	38.7	—
Placebo	37.9	—

Secondary/registry result

Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 3.8 T-score Points Increase From Baseline in SF-36 Physical Component Score

Time frame:Week 56

SF-36 physical

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Liraglutide 3.0 mg	43.7	—
Placebo	41.4	—

Secondary/registry result

Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.6 T-score Points Increase From Baseline in SF-36 Mental Component Score

Time frame:Week 56

SF-36 mental

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Liraglutide 3.0 mg	20.4	—
Placebo	9.3	—

Secondary/registry result

Responder Definition Value for IWQoL-Lite for CT Physical Function Domain (5-items) Score

Time frame:Week 56

IWQOL-Lite physical

threshold achievement, improvement

Posted result

Group	Value (number), Percentage of participants	95% CI
Liraglutide 3.0 mg	37.3	—
Placebo	34.3	—

Secondary/protocol endpoint

Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score

Time frame:Week 0, week 56

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQoL-Lite for CT, Physical Function Domain (5-items) Score

Time frame:Week 0, week 56

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains)

Time frame:Week 0, week 56

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change in Short Form-36 v2.0 Acute (SF-36) (Physical Component Summary (PCS))

Time frame:Week 0, week 56

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in Short Form-36 v2.0 Acute (SF-36) (Mental Component Summary (MCS)

Time frame:Week 0, week 56

SF-36 mental

change from baseline, improvement

Secondary/protocol endpoint

Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Pain/Discomfort Domain Score

Time frame:Week 0, week 56

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Psychosocial Domain Score

Time frame:Week 0, week 56

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Total Score

Time frame:Week 0, week 56

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Change in Weight Related Sign and Symptom (WRSS) Measure, Total Score

Time frame:Week 0, week 56

change from baseline, improvement

Secondary/protocol endpoint

Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.3 T-score Points Increase From Baseline in SF-36 Physical Functioning Score

Time frame:Week 56

SF-36 physical

threshold achievement, improvement

Secondary/protocol endpoint

Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 3.8 T-score Points Increase From Baseline in SF-36 Physical Component Score

Time frame:Week 56

SF-36 physical

threshold achievement, improvement

Secondary/protocol endpoint

Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.6 T-score Points Increase From Baseline in SF-36 Mental Component Score

Time frame:Week 56

SF-36 mental

threshold achievement, improvement

Secondary/protocol endpoint

Responder Definition Value for IWQoL-Lite for CT Physical Function Domain (5-items) Score

Time frame:Week 56

IWQOL-Lite physical

threshold achievement, improvement

Safety / tolerability / PK

23 endpoints

Secondary/registry result

AEs From Randomisation Until and Including the Follow-up Period

Time frame:Week 0 to week 56+30 days

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), events	95% CI
Liraglutide 3.0 mg	867	—
Placebo	601	—

Secondary/registry result

Change in Physical Examination

Time frame:Week 1, week 56

categorical status, descriptive

Posted result

Group	Value (number), participants	95% CI
Liraglutide 3.0 mgAbdomen (week -1) Normal	108	—
Abdomen (week -1) Abnormal, NCS	34	—
Abdomen (week -1) Abnormal CS	0	—
Abdomen (week 56) Normal	114	—
Abdomen (week 56) Abnormal, NCS	25	—
Abdomen (week 56) Abnormal, CS	0	—
Gastrointestinal System (week -1) Normal	130	—
Gastrointestinal System (week -1) Abnormal NCS	12	—
Gastrointestinal System (week -1) Abnormal CS	0	—
Gastrointestinal System (week 56) Normal	132	—
Gastrointestinal System (week 56) Abnormal NCS	7	—
Gastrointestinal System (week 56) Abnormal CS	0	—
Cardiovascular System (week-1) Normal	136	—
Cardiovascular System (week-1) Abnormal NCS	6	—
Cardiovascular System (week-1) Abnormal CS	0	—
Cardiovascular System (week 56) Normal	138	—
Cardiovascular System (week 56) Abnormal NCS	1	—
Cardiovascular System (week 56) Abnormal CS	0	—
Nervous System (week -1) Normal	135	—
Nervous System (week -1) Abnormal NCS	5	—
Nervous System (week -1) Abnormal CS	2	—
Nervous System (week 56) Normal	132	—
Nervous System (week 56) Abnormal NCS	6	—
Nervous System (week 56) Abnormal CS	1	—
General Appearance (week -1) Normal	118	—
General Appearance (week -1) Abnormal NCS	24	—
General Appearance (week -1) Abnormal CS	0	—
General Appearance (week 56) Normal	122	—
General Appearance (week 56) Abnormal NCS	17	—
General Appearance (week 56) Abnormal CS	0	—
Head, ENTand Neck (week -1) Normal	129	—
Head, ENTand Neck (week -1) Abnormal NCS	13	—
Head, ENTand Neck (week -1) Abnormal CS	0	—
Head, ENTand Neck (week 56) Normal	126	—
Head, ENTand Neck (week 56) Abnormal NCS	13	—
Head, ENTand Neck (week 56) Abnormal CS	0	—
Lymph Node Palpation (week -1) Normal	142	—
Lymph Node Palpation (week -1) Abnormal NCS	0	—
Lymph Node Palpation (week -1) Abnormal CS	0	—
Lymph Node Palpation (week 56) Normal	139	—
Lymph Node Palpation (week 56) Abnormal NCS	0	—
Lymph Node Palpation (week 56) Abnormal CS	0	—
Musculoskeletal System (week -1) Normal	131	—
Musculoskeletal System (week -1) Abnormal NCS	11	—
Musculoskeletal System (week -1) Abnormal CS	0	—
Musculoskeletal System (week 56) Normal	130	—
Musculoskeletal System (week 56) Abnormal NCS	9	—
Musculoskeletal System (week 56) Abnormal CS	0	—
Respiratory System (week -1) Normal	140	—
Respiratory System (week -1) Abnormal NCS	2	—
Respiratory System (week -1) Abnormal CS	0	—
Respiratory System (week 56) Normal	138	—
Respiratory System (week 56) Abnormal NCS	1	—
Respiratory System (week 56) Abnormal CS	0	—
Skin (week -1) Normal	116	—
Skin (week -1) Abnormal NCS	26	—
Skin (week -1) Abnormal CS	1	—
Skin (week 56) Normal	117	—
Skin (week 56) Abnormal NCS	21	—
Skin (week 56) Abnormal CS	1	—
Thyroid Gland (week -1) Normal	138	—
Thyroid Gland (week -1) Abnormal NCS	4	—
Thyroid Gland (week -1) Abnormal CS	0	—
Thyroid Gland (week 56) Normal	136	—
Thyroid Gland (week 56) Abnormal NCS	3	—
Thyroid Gland (week 56) Abnormal CS	0	—
PlaceboAbdomen (week -1) Normal	121	—
Abdomen (week -1) Abnormal, NCS	19	—
Abdomen (week -1) Abnormal CS	0	—
Abdomen (week 56) Normal	108	—
Abdomen (week 56) Abnormal, NCS	12	—
Abdomen (week 56) Abnormal, CS	2	—
Gastrointestinal System (week -1) Normal	129	—
Gastrointestinal System (week -1) Abnormal NCS	11	—
Gastrointestinal System (week -1) Abnormal CS	0	—
Gastrointestinal System (week 56) Normal	116	—
Gastrointestinal System (week 56) Abnormal NCS	6	—
Gastrointestinal System (week 56) Abnormal CS	0	—
Cardiovascular System (week-1) Normal	127	—
Cardiovascular System (week-1) Abnormal NCS	13	—
Cardiovascular System (week-1) Abnormal CS	0	—
Cardiovascular System (week 56) Normal	116	—
Cardiovascular System (week 56) Abnormal NCS	5	—
Cardiovascular System (week 56) Abnormal CS	1	—
Nervous System (week -1) Normal	127	—
Nervous System (week -1) Abnormal NCS	6	—
Nervous System (week -1) Abnormal CS	7	—
Nervous System (week 56) Normal	112	—
Nervous System (week 56) Abnormal NCS	9	—
Nervous System (week 56) Abnormal CS	1	—
General Appearance (week -1) Normal	123	—
General Appearance (week -1) Abnormal NCS	17	—
General Appearance (week -1) Abnormal CS	0	—
General Appearance (week 56) Normal	112	—
General Appearance (week 56) Abnormal NCS	10	—
General Appearance (week 56) Abnormal CS	0	—
Head, ENTand Neck (week -1) Normal	128	—
Head, ENTand Neck (week -1) Abnormal NCS	12	—
Head, ENTand Neck (week -1) Abnormal CS	0	—
Head, ENTand Neck (week 56) Normal	115	—
Head, ENTand Neck (week 56) Abnormal NCS	7	—
Head, ENTand Neck (week 56) Abnormal CS	0	—
Lymph Node Palpation (week -1) Normal	140	—
Lymph Node Palpation (week -1) Abnormal NCS	0	—
Lymph Node Palpation (week -1) Abnormal CS	0	—
Lymph Node Palpation (week 56) Normal	121	—
Lymph Node Palpation (week 56) Abnormal NCS	0	—
Lymph Node Palpation (week 56) Abnormal CS	1	—
Musculoskeletal System (week -1) Normal	128	—
Musculoskeletal System (week -1) Abnormal NCS	12	—
Musculoskeletal System (week -1) Abnormal CS	0	—
Musculoskeletal System (week 56) Normal	112	—
Musculoskeletal System (week 56) Abnormal NCS	9	—
Musculoskeletal System (week 56) Abnormal CS	1	—
Respiratory System (week -1) Normal	138	—
Respiratory System (week -1) Abnormal NCS	2	—
Respiratory System (week -1) Abnormal CS	0	—
Respiratory System (week 56) Normal	120	—
Respiratory System (week 56) Abnormal NCS	2	—
Respiratory System (week 56) Abnormal CS	0	—
Skin (week -1) Normal	114	—
Skin (week -1) Abnormal NCS	24	—
Skin (week -1) Abnormal CS	0	—
Skin (week 56) Normal	98	—
Skin (week 56) Abnormal NCS	24	—
Skin (week 56) Abnormal CS	0	—
Thyroid Gland (week -1) Normal	138	—
Thyroid Gland (week -1) Abnormal NCS	2	—
Thyroid Gland (week -1) Abnormal CS	0	—
Thyroid Gland (week 56) Normal	120	—
Thyroid Gland (week 56) Abnormal NCS	2	—
Thyroid Gland (week 56) Abnormal CS	0	—

Secondary/registry result

Change in ECG

Time frame:Week -1, week 56

categorical status, descriptive

Posted result

Group	Value (number), participants	95% CI
Liraglutide 3.0 mgNormal (week -1)	100	—
Abnormal NCS (week -1)	41	—
Abnormal CS (week -1)	1	—
Normal (week 56)	102	—
Abnormal NCS (week 56)	36	—
Abnormal CS (week 56)	0	—
PlaceboNormal (week -1)	91	—
Abnormal NCS (week -1)	49	—
Abnormal CS (week -1)	0	—
Normal (week 56)	81	—
Abnormal NCS (week 56)	42	—
Abnormal CS (week 56)	1	—

Secondary/registry result

Change in Laboratory Measurements: Haematology (Haemoglobin Blood)

Time frame:Week 0, week 56

change from baseline, descriptive

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 3.0 mg	-0.2	—
Placebo	-0.1	—

Secondary/registry result

Change in Laboratory Measurements: Haematology (Haematocrit Blood)

Time frame:Week 0, week 56

change from baseline, descriptive

Posted result

Group	Value (mean), percentage of red blood cells	95% CI
Liraglutide 3.0 mg	-1.5	—
Placebo	-0.9	—

Secondary/registry result

Change in Laboratory Measurements: Haematology (Erythrocytes)

Time frame:Week 0, week 56

change from baseline, descriptive

Posted result

Group	Value (mean), 10^12 cells/L	95% CI
Liraglutide 3.0 mg	-0.11	—
Placebo	-0.08	—

Secondary/registry result

Change in Laboratory Measurements: Haematology (Thrombocytes and Leukocytes)

Time frame:Week 0, week 56

change from baseline, descriptive

componentsthrombocytes, leukocytes

Posted result

Group	Value (mean), 10^9 cells/L	95% CI
Liraglutide 3.0 mgThrombocytes	4	—
Leukocytes	-0.14	—
PlaceboThrombocytes	0	—
Leukocytes	-0.11	—

Secondary/registry result

Change in Laboratory Measurements: Biochemistry (Albumin)

Time frame:Week 0, week 56

albumin serum

change from baseline, descriptive

LOINC 1751-7

Posted result

Group	Value (mean), g/L	95% CI
Liraglutide 3.0 mg	-0.1	—
Placebo	-0.1	—

Secondary/registry result

Change in Laboratory Measurements: Biochemistry (Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase)

Time frame:Week 0, week 56

change from baseline, descriptive

componentsalkaline phosphatase change, ALT, change, amylase change, AST, change, lipase change

Posted result

Group	Value (mean), U/L	95% CI
Liraglutide 3.0 mgAlkaline Phosphatase	-2	—
Alanine Aminotransferase	-5	—
Amylase	4	—
Aspartate aminotransferase	-3	—
Lipase	7	—
PlaceboAlkaline Phosphatase	-1	—
Alanine Aminotransferase	-4	—
Amylase	1	—
Aspartate aminotransferase	-2	—
Lipase	2	—

Secondary/registry result

Change in Laboratory Measurements: Biochemistry (Bilirubin and Creatinine)

Time frame:Week 0, week 56

change from baseline, descriptive

Posted result

Group	Value (mean), umol/L	95% CI
Liraglutide 3.0 mgBilirubin	1.1	—
Creatinine	-1.8	—
PlaceboBilirubin	1.0	—
Creatinine	-1.4	—

Secondary/registry result

Change in Laboratory Measurements: Biochemistry (Total Calcium, Pottassium, Sodium and Urea)

Time frame:Week 0, week 56

change from baseline, descriptive

Posted result

Group	Value (mean), mmol/L	95% CI
Liraglutide 3.0 mgTotal Calcium	0.01	—
Potassium	-0.0	—
Sodium	-0.0	—
Urea	0.0	—
PlaceboTotal Calcium	0.01	—
Potassium	-0.0	—
Sodium	-0	—
Urea	0.2	—

Secondary/registry result

Change in Laboratory Measurements: Biochemistry (Calcitonin)

Time frame:Week 0, week 56

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (mean), ng/L	95% CI
Liraglutide 3.0 mg	0.2	—
Placebo	0.1	—

Secondary/registry result

Change in Laboratory Measurements: Biochemistry (Thyroid Stimulating Hormone)

Time frame:Week 0, week 56

Thyroid event

change from baseline, descriptive

Posted result

Group	Value (mean), mIU/L	95% CI
Liraglutide 3.0 mg	-0.2313	—
Placebo	0.2685	—

Secondary/protocol endpoint

AEs From Randomisation Until and Including the Follow-up Period

Time frame:Week 0 to week 56+30 days

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Change in Physical Examination

Time frame:Week 1, week 56

categorical status, descriptive

Secondary/protocol endpoint

Change in ECG

Time frame:Week -1, week 56

categorical status, descriptive

Secondary/protocol endpoint

Change in Laboratory Measurements: Haematology (Haematocrit Blood)

Time frame:Week 0, week 56

change from baseline, descriptive

Secondary/protocol endpoint

Change in Laboratory Measurements: Haematology (Thrombocytes and Leukocytes)

Time frame:Week 0, week 56

change from baseline, descriptive

Secondary/protocol endpoint

Change in Laboratory Measurements: Biochemistry (Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase)

Time frame:Week 0, week 56

change from baseline, descriptive

Secondary/protocol endpoint

Change in Laboratory Measurements: Biochemistry (Bilirubin and Creatinine)

Time frame:Week 0, week 56

change from baseline, descriptive

Secondary/protocol endpoint

Change in Laboratory Measurements: Biochemistry (Total Calcium, Pottassium, Sodium and Urea)

Time frame:Week 0, week 56

change from baseline, descriptive

componentstotal calcium, potassium, sodium, urea

Secondary/protocol endpoint

Change in Laboratory Measurements: Biochemistry (Calcitonin)

Time frame:Week 0, week 56

change from baseline, descriptive

Secondary/protocol endpoint

Change in Laboratory Measurements: Biochemistry (Thyroid Stimulating Hormone)

Time frame:Week 0, week 56

change from baseline, descriptive

Other clinical outcomes

9 endpoints

Secondary/registry result

Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Trial Product

Time frame:Week 0, week 56

descriptive

Posted result

Group	Value (mean), weeks	95% CI
Liraglutide 3.0 mg	49.5	—
Placebo	46.8	—

Secondary/registry result/low confidence

Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet

Time frame:Week 0, week 56

descriptive

Posted result

Group	Value (mean), weeks	95% CI
Liraglutide 3.0 mg	38.4	—
Placebo	36.1	—

Secondary/registry result

Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Physical Activity

Time frame:Week 0, week 56

descriptive

Posted result

Group	Value (mean), weeks	95% CI
Liraglutide 3.0 mg	29.0	—
Placebo	30.0	—

Secondary/registry result/low confidence

Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet and Physical Activity

Time frame:Week 0, week 56

descriptive

Posted result

Group	Value (mean), weeks	95% CI
Liraglutide 3.0 mg	24.0	—
Placebo	24.5	—

Secondary/registry result

Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet, Physical Activity and Trial Product

Time frame:Week 0, week 56

descriptive

Posted result

Group	Value (mean), weeks	95% CI
Liraglutide 3.0 mg	22.9	—
Placebo	24.0	—

Secondary/protocol endpoint

Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet

Time frame:Week 0, week 56

descriptive

Secondary/protocol endpoint

Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Physical Activity

Time frame:Week 0, week 56

descriptive

Secondary/protocol endpoint

Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet and Physical Activity

Time frame:Week 0, week 56

descriptive

Secondary/protocol endpoint/low confidence

Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet, Physical Activity and Trial Product

Time frame:Week 0, week 56

descriptive

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Trial Product

Time frame:Week 0, week 56

descriptive

Secondary/protocol endpoint/low confidence

Change in Laboratory Measurements: Haematology (Haemoglobin Blood)

Time frame:Week 0, week 56

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Laboratory Measurements: Haematology (Erythrocytes)

Time frame:Week 0, week 56

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Laboratory Measurements: Biochemistry (Albumin)

Time frame:Week 0, week 56

change from baseline, descriptive

Publications (1)

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 3.0 mg and Intensive Behavioral Therapy (IBT) for Obesity in Primary Care: The SCALE IBT Randomized Controlled Trial.
Obesity (Silver Spring, Md.)2020 Mar (month)PMID32090517doi:10.1002/oby.22726via CT.gov reference

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.