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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00781937
Recruitment Status : Completed
First Posted : October 29, 2008
Results First Posted : November 28, 2011
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief 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).


Condition or disease Intervention/treatment Phase
Metabolism and Nutrition Disorder Obesity Drug: liraglutide Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 30, 2008
Actual Primary Completion Date : September 1, 2010
Actual Study Completion Date : September 1, 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

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

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




Primary Outcome Measures :
  1. Mean Percentage Change in Fasting Body Weight From Baseline [ Time Frame: Week 0, week 56 ]
    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

  2. Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0 [ Time Frame: Week 0, week 56 ]
    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.

  3. Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0 [ Time Frame: Week 0, week 56 ]
    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.


Secondary Outcome Measures :
  1. Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0 [ Time Frame: Week 0, week 56 ]
    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

  2. Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0 [ Time Frame: Week 0, week 56 ]
    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

  3. Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0 [ Time Frame: Week 0, week 56 ]
    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

  4. Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0 [ Time Frame: Week 0, week 56 ]
    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

  5. Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0 [ Time Frame: Week 0, week 56 ]
    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

  6. Change From Baseline in Fasting Weight [ Time Frame: Week 0, week 56 ]
    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

  7. 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 ]
    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

  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 [ Time Frame: Week 0, week 56 ]
    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

  11. Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: Week 0, week 56 ]
    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

  12. Change From Baseline in Fasting Lipid Profile: Total Cholesterol [ Time Frame: Week 0, week 56 ]
    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

  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 [ Time Frame: 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.

  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) [ Time Frame: Week 0, week 56 ]
    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%.

  18. Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance) [ Time Frame: Week 0, week 56 ]
    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.

  19. Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 56 ]
    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

  20. Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin [ Time Frame: Week 0, week 56 ]
    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

  21. Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 56 ]
    Change in HbA1c percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%].

  22. Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications) [ Time Frame: Week 0 and week 56 ]
    Number of subjects using concomitant medications at Week 0 and Week 56, respectively

  23. Binge Eating Scale Scores by Week and Severity [ Time Frame: Week 0, week 50 and week 57 ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781937


Locations
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United States, Arizona
Novo Nordisk Investigational Site
Goodyear, Arizona, United States, 85395
Novo Nordisk Investigational Site
Peoria, Arizona, United States, 85381
United States, California
Novo Nordisk Investigational Site
Huntington Beach, California, United States, 92648
Novo Nordisk Investigational Site
Montclair, California, United States, 91763
United States, Colorado
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States, 80909
United States, Florida
Novo Nordisk Investigational Site
Hialeah, Florida, United States, 33013-3835
Novo Nordisk Investigational Site
Pembroke Pines, Florida, United States, 33024
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30106
United States, Idaho
Novo Nordisk Investigational Site
Meridian, Idaho, United States, 83642
United States, Kentucky
Novo Nordisk Investigational Site
Louisville, Kentucky, United States, 40213
Novo Nordisk Investigational Site
Madisonville, Kentucky, United States, 42431
United States, Michigan
Novo Nordisk Investigational Site
Southfield, Michigan, United States, 48034
United States, Missouri
Novo Nordisk Investigational Site
Saint Louis, Missouri, United States, 63110
United States, Montana
Novo Nordisk Investigational Site
Butte, Montana, United States, 59701
United States, New York
Novo Nordisk Investigational Site
Endwell, New York, United States, 13760
Novo Nordisk Investigational Site
New York, New York, United States, 10065
United States, North Carolina
Novo Nordisk Investigational Site
Wilmington, North Carolina, United States, 28401
Novo Nordisk Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45236
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45245
United States, Pennsylvania
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Novo Nordisk Investigational Site
Charleston, South Carolina, United States, 29406
United States, Tennessee
Novo Nordisk Investigational Site
Nashville, Tennessee, United States, 37212
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75246
Novo Nordisk Investigational Site
Round Rock, Texas, United States, 78681
United States, Virginia
Novo Nordisk Investigational Site
Norfolk, Virginia, United States, 23502
Canada, Manitoba
Novo Nordisk Investigational Site
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Ontario
Novo Nordisk Investigational Site
Burlington, Ontario, Canada, L7M 4Y1
Novo Nordisk Investigational Site
Hamilton, Ontario, Canada, L8L 5G8
Novo Nordisk Investigational Site
Sarnia, Ontario, Canada, N7T 4X3
Canada, Quebec
Novo Nordisk Investigational Site
Laval, Quebec, Canada, H7T 2P5
Novo Nordisk Investigational Site
Mirabel, Quebec, Canada, J7J 2K8
Novo Nordisk Investigational Site
Sherbrooke, Quebec, Canada, J1H 4J6
Novo Nordisk Investigational Site
Trois Rivières, Quebec, Canada, G8T 7A1
Canada
Novo Nordisk Investigational Site
London, Canada, N5Y 5K7
Novo Nordisk Investigational Site
Montreal, Canada, H2W 1R7
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00781937    
Other Study ID Numbers: NN8022-1923
First Posted: October 29, 2008    Key Record Dates
Results First Posted: November 28, 2011
Last Update Posted: November 1, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Nutrition Disorders
Weight Loss
Body Weight Changes
Body Weight
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists