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CompletedNCT00781937Updated Nov 1, 2017Results posted

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

A Phase 3 interventional study of liraglutide and placebo in Metabolism and Nutrition Disorder and Obesity, sponsored by Novo Nordisk A/S. Completed at 37 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-01.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
422
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This trial is conducted in North America. The aim of this clinical trial is to evaluate the potential of liraglutide to maintain long term weight loss in obese non-diabetic subjects, as well as in overweight subjects who have medical problems such as hypertension (high blood pressure) or dyslipidaemia (an abnormal amount of lipids in the blood).

Trial has following trial periods: A 12-week run-in period (from week -12 to week 0) followed by a 56-week main trial period (weeks 0-56) and a 12-week follow-up period (weeks 56-68).

02

Conditions studied

  • Metabolism and Nutrition Disorder
  • Obesity
03

In context

Nutrition Disorders

275 studies on the registry are indexed under Nutrition Disorders; 31 are open to participants now.

This study's enrollment of 422 is above the median of 117 across 194 interventional studies indexed under Nutrition Disorders.

Browse Nutrition Disorders studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 101 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
422 participants (actual)

Study arms

  • Experimental
    Lira 3.0 mg

    A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached

    Drug: liraglutide

  • Placebo comparator
    Placebo

    A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period

    Drug: placebo

Interventions

  • Drugliraglutide

    Liraglutide 3.0 mg per day administered in a 6.0 mg/mL, 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily

  • Drugplacebo

    Liraglutide placebo 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily

06

What researchers measure

Primary outcomes

  1. Mean Percentage Change in Fasting Body Weight From Baseline

    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Time frame: Week 0, week 56

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

    Subjects who had a weight regain less than or equal to 0.5% of weight from Week 0 were regarded as maintenance of run-in fasting weight loss. Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Time frame: Week 0, week 56

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

    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Time frame: Week 0, week 56

Secondary outcomes

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

    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Time frame: Week 0, week 56

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

    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Time frame: Week 0, week 56

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

    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Time frame: Week 0, week 56

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

    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Time frame: Week 0, week 56

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

    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Time frame: Week 0, week 56

  6. Change From Baseline in Fasting Weight

    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Time frame: Week 0, week 56

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

    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

    Time frame: Week 0, week 68

  8. Change From Baseline in Blood Pressure

    Time frame: Week 0, week 56

  9. Change From Baseline in Pulse

    Time frame: Week 0, week 56

  10. Change From Baseline in Fasting Lipid Profile: Triglycerides

    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

    Time frame: Week 0, week 56

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

    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

    Time frame: Week 0, week 56

  12. Change From Baseline in Fasting Lipid Profile: Total Cholesterol

    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

    Time frame: Week 0, week 56

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

    Time frame: Week 0, week 56

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

    Metabolic syndrome status required at least 3 of 5 criteria met: Waist circumference (men ≥102cm, women ≥88cm); Triglycerides \>1.7mmol/L; High density lipoprotein cholesterol (men \<0.9mmol/L, women \<1.1mmol/L) or on drug therapy; Blood pressure ≥130mmHg systolic or ≥85mmHg diastolic or on drug therapy; Fasting glucose ≥5.5mmol/L or on drug therapy.

    Time frame: Week 56

  15. Change From Baseline in Waist Circumference

    Time frame: Week 0, week 56

  16. Change From Baseline in Body Mass Index (BMI)

    Time frame: Week 0, week 56

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

    Change in beta-cell function percent values from Week 0 (X%) to Week 56 (Y%) was calculated \[X% - Y%\]. Beta-cell function was derived from fasting plasma glucose readings in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged \<35 years have median beta-cell function indexed at 100%.

    Time frame: Week 0, week 56

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

    Change in insulin resistance values from Week 0 (X) to Week 56 (Y) was calculated \[X - Y\]. Insulin resistance was derived from fasting serum insulin levels in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged \<35 years have median insulin resistance indexed at 1.00.

    Time frame: Week 0, week 56

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

    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

    Time frame: Week 0, week 56

  20. Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin

    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

    Time frame: Week 0, week 56

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

    Change in HbA1c percent values from Week 0 (X%) to Week 56 (Y%) was calculated \[X% - Y%\].

    Time frame: Week 0, week 56

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

    Number of subjects using concomitant medications at Week 0 and Week 56, respectively

    Time frame: Week 0 and week 56

  23. Binge Eating Scale Scores by Week and Severity

    Binge Eating Scale (BES) scores are based on responses to the Binge Eating Scale Questionnaire, a 16-item self-reporting diagnostic tool scaled 0-46 (Non-binging: 0-17; Moderate: 17-26; Severe: 27-46)

    Time frame: Week 0, week 50 and week 57

07

Results

Posted Nov 28, 2011

Participant flow

The trial was conducted at 26 sites in the United States and 10 sites in Canada.

Main Trial Period Through Week 56
Participant flow — Main Trial Period Through Week 56
MilestoneLira 3.0 mgPlacebo
Started212210
Completed159146
Not completed5364
Withdrew: Adverse event1818
Withdrew: Lack of efficacy02
Withdrew: Protocol violation85
Withdrew: Withdrawal by subject1724
Withdrew: Unclassified1015
Follow up Period (Week 56-68)
Participant flow — Follow up Period (Week 56-68)
MilestoneLira 3.0 mgPlacebo
Started159146
Completed153141
Not completed65
Withdrew: Protocol violation11
Withdrew: Unclassified54

Outcome measures

PrimaryMean Percentage Change in Fasting Body Weight From Baseline

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Time frame:
Week 0, week 56
Reported as:
Least squares mean · percentage
Mean Percentage Change in Fasting Body Weight From Baseline
percentageLira 3.0 mgPlacebo
Mean Percentage Change in Fasting Body Weight From Baseline-6.11 ± 0.66-0.05 ± 0.63
Statistical analysis
  • Lira 3.0 mg vs Placebo · ANCOVA · p = <0.0001 (Two sided, conducted at a 5% significance level) · Treatment contrast: -6.06 · 95% CI -7.50 to -4.62The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.
PrimaryPercentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0

Subjects who had a weight regain less than or equal to 0.5% of weight from Week 0 were regarded as maintenance of run-in fasting weight loss. Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Time frame:
Week 0, week 56
Reported as:
Number · percentage of subjects
Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0
percentage of subjectsLira 3.0 mgPlacebo
Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 080.847.9
Statistical analysis
  • Lira 3.0 mg vs Placebo · Regression, Logistic · p = <0.0001 (Two sided, conducted at a 5% significance level) · Odds ratio (or): 4.82 · 95% CI 3.01 to 7.71The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.
PrimaryPercentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Time frame:
Week 0, week 56
Reported as:
Number · percentage of subjects
Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0
percentage of subjectsLira 3.0 mgPlacebo
Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 050.521.9
Statistical analysis
  • Lira 3.0 mg vs Placebo · Regression, Logistic · p = <0.0001 (Two sided, conducted at a 5% significance level) · Odds ratio (or): 3.86 · 95% CI 2.44 to 6.09The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.
SecondaryPercentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Time frame:
Week 0, week 56
Reported as:
Number · percentage of subjects
Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0
percentage of subjectsLira 3.0 mgPlacebo
Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 026.16.3
Statistical analysis
  • Lira 3.0 mg vs Placebo · Regression, Logistic · p = <0.0001 (Two sided, conducted at a 5% significance level) · Odds ratio (or): 5.30 · 95% CI 2.79 to 10.08The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.
SecondaryPercentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Time frame:
Week 0, week 56
Reported as:
Number · percentage of subjects
Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0
percentage of subjectsLira 3.0 mgPlacebo
Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 01.917.5
Statistical analysis
  • Lira 3.0 mg vs Placebo · Regression, Logistic · p = <0.0001 (Two sided, conducted at a 5% significance level) · Odds ratio (or): 0.09 · 95% CI 0.03 to 0.26The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.
SecondaryPercentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Time frame:
Week 0, week 56
Reported as:
Number · percentage of subjects
Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0
percentage of subjectsLira 3.0 mgPlacebo
Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 002.9
SecondaryPercentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Time frame:
Week 0, week 56
Reported as:
Number · percentage of subjects
Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0
percentage of subjectsLira 3.0 mgPlacebo
Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 093.270.9
Statistical analysis
  • Lira 3.0 mg vs Placebo · Regression, Logistic · p = <0.0001 (Two sided, conducted at a 5% significance level) · Odds ratio (or): 5.86 · 95% CI 3.12 to 10.98The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.
SecondaryPercentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Time frame:
Week 0, week 56
Reported as:
Number · percentage of subjects
Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0
percentage of subjectsLira 3.0 mgPlacebo
Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 087.454.4
Statistical analysis
  • Lira 3.0 mg vs Placebo · Regression, Logistic · p = <0.0001 (Two sided, conducted at a 5% significance level) · Odds ratio (or): 6.02 · 95% CI 3.65 to 9.92The analysis included treatment, gender, country, and stratification factor(s) as fixed effects and randomisation value of endpoint as covariate.
SecondaryChange From Baseline in Fasting Weight

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Time frame:
Week 0, week 56
Reported as:
Least squares mean · kg
Change From Baseline in Fasting Weight
kgLira 3.0 mgPlacebo
Change From Baseline in Fasting Weight-5.7 ± 0.660.16 ± 0.63
Statistical analysis
  • Lira 3.0 mg vs Placebo · ANCOVA · p = <0.0001 (Two sided, conducted at a 5% significance level) · Treatment contrast: -5.86 · 95% CI -7.30 to -4.43The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.
SecondaryChange From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period

Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Time frame:
Week 0, week 68
Reported as:
Least squares mean · kg
Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period
kgLira 3.0 mgPlacebo
Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period-3.83 ± 0.820.41 ± 0.78
Statistical analysis
  • Lira 3.0 mg vs Placebo · ANCOVA · p = <0.0001 (Two sided, conducted at a 5% significance level) · Treatment contrast: -4.23 · 95% CI -6.04 to -2.43The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.
SecondaryChange From Baseline in Blood Pressure
Time frame:
Week 0, week 56
Reported as:
Least squares mean · mmHg
Change From Baseline in Blood Pressure
mmHgLira 3.0 mgPlacebo
Change in Systolic Blood Pressure1.31 ± 0.904.03 ± 0.87
Change in Diastolic Blood Pressure1.81 ± 0.642.15 ± 0.61
Statistical analysis
  • Lira 3.0 mg vs Placebo · ANCOVA · p = 0.0068 (Two sided, conducted at a 5% significance level) · Treatment contrast: -2.72 · 95% CI -4.69 to -0.76The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.
  • Lira 3.0 mg vs Placebo · ANCOVA · p = 0.6386 (Two sided, conducted at a 5% significance level) · Treatment contrast: -0.34 · 95% CI -1.74 to 1.07The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.
SecondaryChange From Baseline in Pulse
Time frame:
Week 0, week 56
Reported as:
Least squares mean · beats/minute
Change From Baseline in Pulse
beats/minuteLira 3.0 mgPlacebo
Change From Baseline in Pulse4.12 ± 0.683.15 ± 0.65
Statistical analysis
  • Lira 3.0 mg vs Placebo · ANCOVA · p = 0.1968 (Two sided, conducted at a 5% significance level) · Treatment contrast: 0.97 · 95% CI -0.51 to 2.45The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.
SecondaryChange From Baseline in Fasting Lipid Profile: Triglycerides

Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

Time frame:
Week 0, week 56
Reported as:
Least squares mean · mmol/L
Change From Baseline in Fasting Lipid Profile: Triglycerides
mmol/LLira 3.0 mgPlacebo
Change From Baseline in Fasting Lipid Profile: Triglycerides0.02 ± 0.040.12 ± 0.04
Statistical analysis
  • Lira 3.0 mg vs Placebo · ANCOVA · p = 0.0310 (Two sided, conducted at a 5% significance level) · Treatment contrast: -0.11 · 95% CI -0.20 to -0.01The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.
SecondaryChange From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol

Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

Time frame:
Week 0, week 56
Reported as:
Least squares mean · mmol/L
Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol
mmol/LLira 3.0 mgPlacebo
Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol0.24 ± 0.050.33 ± 0.05
Statistical analysis
  • Lira 3.0 mg vs Placebo · ANCOVA · p = 0.1098 (Two sided, conducted at a 5% significance level) · Treatment contrast: -0.09 · 95% CI -0.20 to 0.02The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.
SecondaryChange From Baseline in Fasting Lipid Profile: Total Cholesterol

Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

Time frame:
Week 0, week 56
Reported as:
Least squares mean · mmol/L
Change From Baseline in Fasting Lipid Profile: Total Cholesterol
mmol/LLira 3.0 mgPlacebo
Change From Baseline in Fasting Lipid Profile: Total Cholesterol0.22 ± 0.060.33 ± 0.06
Statistical analysis
  • Lira 3.0 mg vs Placebo · ANCOVA · p = 0.1149 (Two sided, conducted at a 5% significance level) · Treatment contrast: -0.11 · 95% CI -0.24 to 0.03The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.
SecondaryChange From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)
Time frame:
Week 0, week 56
Reported as:
Least squares mean · nmol/L
Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)
nmol/LLira 3.0 mgPlacebo
Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)-11.31 ± 4.621.70 ± 4.51
Statistical analysis
  • Lira 3.0 mg vs Placebo · ANCOVA · p = 0.0141 (Two sided, conducted at a 5% significance level) · Treatment contrast: -13.01 · 95% CI -23.40 to -2.64The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.
SecondaryPercentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56

Metabolic syndrome status required at least 3 of 5 criteria met: Waist circumference (men ≥102cm, women ≥88cm); Triglycerides \>1.7mmol/L; High density lipoprotein cholesterol (men \<0.9mmol/L, women \<1.1mmol/L) or on drug therapy; Blood pressure ≥130mmHg systolic or ≥85mmHg diastolic or on drug therapy; Fasting glucose ≥5.5mmol/L or on drug therapy.

Time frame:
Week 56
Reported as:
Number · percentage of subjects
Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56
percentage of subjectsLira 3.0 mgPlacebo
Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 5631.436.7
Statistical analysis
  • Lira 3.0 mg vs Placebo · Regression, Logistic · p = 0.1199 (Two sided, conducted at a 5% significance level) · Odds ratio (or): 0.64 · 95% CI 0.36 to 1.12The analysis included treatment, gender, and stratification factor(s) as fixed effects and metabolic status and weight at baseline as covariates.
SecondaryChange From Baseline in Waist Circumference
Time frame:
Week 0, week 56
Reported as:
Least squares mean · cm
Change From Baseline in Waist Circumference
cmLira 3.0 mgPlacebo
Change From Baseline in Waist Circumference-4.36 ± 0.62-0.86 ± 0.59
Statistical analysis
  • Lira 3.0 mg vs Placebo · ANCOVA · p = <0.0001 (Two sided, conducted at a 5% significance level) · Treatment contrast: -3.50 · 95% CI -4.84 to -2.15The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.
SecondaryChange From Baseline in Body Mass Index (BMI)
Time frame:
Week 0, week 56
Reported as:
Least squares mean · kg/m^2
Change From Baseline in Body Mass Index (BMI)
kg/m^2Lira 3.0 mgPlacebo
Change From Baseline in Body Mass Index (BMI)-1.90 ± 0.220.15 ± 0.21
Statistical analysis
  • Lira 3.0 mg vs Placebo · ANCOVA · p = <0.0001 (Two sided, conducted at a 5% significance level) · Treatment contrast: -2.05 · 95% CI -2.53 to -1.57The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.
SecondaryChange From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)

Change in beta-cell function percent values from Week 0 (X%) to Week 56 (Y%) was calculated \[X% - Y%\]. Beta-cell function was derived from fasting plasma glucose readings in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged \<35 years have median beta-cell function indexed at 100%.

Time frame:
Week 0, week 56
Reported as:
Least squares mean · percent change
Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)
percent changeLira 3.0 mgPlacebo
Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)8.51 ± 2.336.16 ± 2.27
Statistical analysis
  • Lira 3.0 mg vs Placebo · ANCOVA · p = 0.3689 (Two sided, conducted at a 5% significance level) · Treatment contrast: 2.35 · 95% CI -2.79 to 7.49The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.
SecondaryChange From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)

Change in insulin resistance values from Week 0 (X) to Week 56 (Y) was calculated \[X - Y\]. Insulin resistance was derived from fasting serum insulin levels in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged \<35 years have median insulin resistance indexed at 1.00.

Time frame:
Week 0, week 56
Reported as:
Least squares mean · proportion
Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)
proportionLira 3.0 mgPlacebo
Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)-0.01 ± 0.030.08 ± 0.03
Statistical analysis
  • Lira 3.0 mg vs Placebo · ANCOVA · p = 0.0053 (Two sided, conducted at a 5% significance level) · Treatment contrast: -0.10 · 95% CI -0.16 to -0.03The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.
SecondaryChange From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)

Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

Time frame:
Week 0, week 56
Reported as:
Least squares mean · mmol/L
Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)
mmol/LLira 3.0 mgPlacebo
Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)-0.52 ± 0.05-0.14 ± 0.05
Statistical analysis
  • Lira 3.0 mg vs Placebo · ANCOVA · p = <0.0001 (Two sided, conducted at a 5% significance level) · Treatment contrast: -0.38 · 95% CI -0.50 to -0.26The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.
SecondaryChange From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin

Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

Time frame:
Week 0, week 56
Reported as:
Least squares mean · pmol/L
Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin
pmol/LLira 3.0 mgPlacebo
Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin0.50 ± 0.672.35 ± 0.65
Statistical analysis
  • Lira 3.0 mg vs Placebo · ANCOVA · p = 0.0147 (Two sided, conducted at a 5% significance level) · Treatment contrast: -1.85 · 95% CI -3.34 to -0.37The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.
SecondaryChange From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)

Change in HbA1c percent values from Week 0 (X%) to Week 56 (Y%) was calculated \[X% - Y%\].

Time frame:
Week 0, week 56
Reported as:
Least squares mean · percentage point
Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)
percentage pointLira 3.0 mgPlacebo
Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin)-0.14 ± 0.030.13 ± 0.03
Statistical analysis
  • Lira 3.0 mg vs Placebo · ANCOVA · p = <0.0001 (Two sided, conducted at a 5% significance level) · Treatment contrast: -0.27 · 95% CI -0.33 to -0.21The analysis included treatment, gender, country and stratification factor(s) as fixed effects and randomisation value of the endpoint as covariate.
SecondaryNumber of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications)

Number of subjects using concomitant medications at Week 0 and Week 56, respectively

Time frame:
Week 0 and week 56
Reported as:
Number · Subjects
Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications)
SubjectsLira 3.0 mgPlacebo
Antihypertensive drug - Week 06566
Antihypertensive drug - Week 566363
Antipsychotic drug - Week 01825
Antipsychotic drug - Week 562029
Lipid lowering drug - Week 04545
Lipid lowering drug - Week 565250
SecondaryBinge Eating Scale Scores by Week and Severity

Binge Eating Scale (BES) scores are based on responses to the Binge Eating Scale Questionnaire, a 16-item self-reporting diagnostic tool scaled 0-46 (Non-binging: 0-17; Moderate: 17-26; Severe: 27-46)

Time frame:
Week 0, week 50 and week 57
Reported as:
Mean · scores on a scale
Binge Eating Scale Scores by Week and Severity
scores on a scaleLira 3.0 mgPlacebo
Week 0, baseline7.8 ± 5.67.8 ± 6.2
Week 506.6 ± 5.68.6 ± 7.0
Week 576.6 ± 5.86.9 ± 6.2

Adverse events

Collected over Treatment emergent adverse events were defined as occurring before randomisation and increasing in severity during treatment, or had onset on or after first day of randomised treatment and no later than 7 days after last day of randomised treatment.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lira 3.0 mg—9/212 (4.2%)177/212 (83.5%)
Placebo—5/210 (2.4%)163/210 (77.6%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventLira 3.0 mgPlacebo
AppendicitisInfections and infestations0/2122/210
CholelithiasisHepatobiliary disorders2/2120/210
SepsisInfections and infestations0/2121/210
Cardiac FailureCardiac disorders0/2121/210
HidradenitisSkin and subcutaneous tissue disorders0/2121/210
Aortic aneurysmVascular disorders0/2121/210
Breast CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/2120/210
Breast Cancer in situNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/2120/210
Ovarian CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/2120/210
Thyroid CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/2120/210
Most frequent other events
Showing 10 of 26
Most frequent other events
EventLira 3.0 mgPlacebo
NauseaGastrointestinal disorders101/21236/210
ConstipationGastrointestinal disorders57/21226/210
NasopharyngitisInfections and infestations36/21247/210
DiarrhoeaGastrointestinal disorders38/21226/210
VomitingGastrointestinal disorders35/2125/210
SinusitisInfections and infestations16/21227/210
HeadacheNervous system disorders27/21226/210
Upper Respiratory Tract InfectionInfections and infestations26/21223/210
Injection Site HaematomaGeneral disorders17/21224/210
InfluenzaInfections and infestations15/21222/210

Baseline characteristics

Age, Continuous
Age, Continuous(years)Lira 3.0 mgPlaceboTotal
Mean45.9 ± 11.946.5 ± 11.046.2 ± 11.5
Sex: Female, Male
Sex: Female, Male(Participants)Lira 3.0 mgPlaceboTotal
Female178165343
Male344579
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Lira 3.0 mgPlaceboTotal
Hispanic or Latino171128
Not Hispanic or Latino195199394
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Lira 3.0 mgPlaceboTotal
American Indian or Alaska Native000
Asian101
Native Hawaiian or Other Pacific Islander202
Black or African American322456
White170185355
More than one race000
Unknown or Not Reported718
Co-morbidity status
Co-morbidity status(participants)Lira 3.0 mgPlaceboTotal
Present9496190
Absent118114232
Co-morbidity status and Body Mass Index (BMI)
Co-morbidity status and Body Mass Index (BMI)(participants)Lira 3.0 mgPlaceboTotal
Present and BMI (27-30) kg/m^2369
Present and BMI >=30 kg/m^29190181
Absent and BMI >=30 kg/m^2118114232
Smoking
Smoking(participants)Lira 3.0 mgPlaceboTotal
Yes202242
No192188380
Height
Height(meters)Lira 3.0 mgPlaceboTotal
Mean1.67 ± 0.091.67 ± 0.091.67 ± 0.09

5 further baseline measures are reported on the registry.

08

Study locations

37 sites
  • Novo Nordisk Investigational Site
    Goodyear, Arizona 85395, United States
  • Novo Nordisk Investigational Site
    Peoria, Arizona 85381, United States
  • Novo Nordisk Investigational Site
    Huntington Beach, California 92648, United States
  • Novo Nordisk Investigational Site
    Montclair, California 91763, United States
  • Novo Nordisk Investigational Site
    Colorado Springs, Colorado 80909, United States
  • Novo Nordisk Investigational Site
    Hialeah, Florida 33013-3835, United States
  • Novo Nordisk Investigational Site
    Pembroke Pines, Florida 33024, United States
  • Novo Nordisk Investigational Site
    Atlanta, Georgia 30106, United States
  • Novo Nordisk Investigational Site
    Meridian, Idaho 83642, United States
  • Novo Nordisk Investigational Site
    Louisville, Kentucky 40213, United States
  • Novo Nordisk Investigational Site
    Madisonville, Kentucky 42431, United States
  • Novo Nordisk Investigational Site
    Southfield, Michigan 48034, United States
  • Novo Nordisk Investigational Site
    Saint Louis, Missouri 63110, United States
  • Novo Nordisk Investigational Site
    Butte, Montana 59701, United States
  • Novo Nordisk Investigational Site
    Endwell, New York 13760, United States
  • Novo Nordisk Investigational Site
    New York, New York 10065, United States
  • Novo Nordisk Investigational Site
    Wilmington, North Carolina 28401, United States
  • Novo Nordisk Investigational Site
    Winston-Salem, North Carolina 27103, United States
  • Novo Nordisk Investigational Site
    Cincinnati, Ohio 45236, United States
  • Novo Nordisk Investigational Site
    Cincinnati, Ohio 45245, United States
  • Novo Nordisk Investigational Site
    Philadelphia, Pennsylvania 19104, United States
  • Novo Nordisk Investigational Site
    Philadelphia, Pennsylvania 19107, United States
  • Novo Nordisk Investigational Site
    Charleston, South Carolina 29406, United States
  • Novo Nordisk Investigational Site
    Nashville, Tennessee 37212, United States
  • Novo Nordisk Investigational Site
    Dallas, Texas 75246, United States
  • Novo Nordisk Investigational Site
    Round Rock, Texas 78681, United States
  • Novo Nordisk Investigational Site
    Norfolk, Virginia 23502, United States
  • Novo Nordisk Investigational Site
    Winnipeg, Manitoba R3E 3P4, Canada
  • Novo Nordisk Investigational Site
    Burlington, Ontario L7M 4Y1, Canada
  • Novo Nordisk Investigational Site
    Hamilton, Ontario L8L 5G8, Canada
  • Novo Nordisk Investigational Site
    Sarnia, Ontario N7T 4X3, Canada
  • Novo Nordisk Investigational Site
    Laval, Quebec H7T 2P5, Canada
  • Novo Nordisk Investigational Site
    Mirabel, Quebec J7J 2K8, Canada
  • Novo Nordisk Investigational Site
    Sherbrooke, Quebec J1H 4J6, Canada
  • Novo Nordisk Investigational Site
    Trois Rivières, Quebec G8T 7A1, Canada
  • Novo Nordisk Investigational Site
    London, N5Y 5K7, Canada
  • Novo Nordisk Investigational Site
    Montreal, H2W 1R7, Canada
09

References and documents

Publications

  • O'Neil PM, Garvey WT, Gonzalez-Campoy JM, Mora P, Ortiz RV, Guerrero G, Claudius B, Pi-Sunyer X; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS. Endocr Pract. 2016 Nov;22(11):1277-1287. doi: 10.4158/EP151181.OR. Epub 2016 Aug 2. PubMed 27482610 ↗
  • Bays H, Pi-Sunyer X, Hemmingsson JU, Claudius B, Jensen CB, Van Gaal L. Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects. Curr Med Res Opin. 2017 Feb;33(2):225-229. doi: 10.1080/03007995.2016.1251892. Epub 2016 Nov 6. PubMed 27817208 ↗
  • Wadden TA, Hollander P, Klein S, Niswender K, Woo V, Hale PM, Aronne L; NN8022-1923 Investigators. Weight maintenance and additional weight loss with liraglutide after low-calorie-diet-induced weight loss: the SCALE Maintenance randomized study. Int J Obes (Lond). 2013 Nov;37(11):1443-51. doi: 10.1038/ijo.2013.120. Epub 2013 Jul 1. Erratum In: Int J Obes (Lond). 2013 Nov;37(11):1514. Int J Obes (Lond). 2015 Jan;39(1):187. doi: 10.1038/ijo.2014.88. PubMed 23812094 ↗
  • McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814. PubMed 26418188 ↗
  • Steinberg WM, Rosenstock J, Wadden TA, Donsmark M, Jensen CB, DeVries JH. 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 Care. 2017 Jul;40(7):839-848. doi: 10.2337/dc16-2684. Epub 2017 May 4. Erratum In: Diabetes Care. 2018 Jul;41(7):1538. doi: 10.2337/dc18-er07. PubMed 28473337 ↗
  • O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21. PubMed 28386912 ↗
  • Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1. PubMed 28950422 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00781937
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Oct 29, 2008
Start date
Oct 30, 2008
Primary completion
Sep 1, 2010
Completion
Sep 1, 2010
Results posted
Nov 28, 2011
Last update
Nov 1, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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