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OpenTrials
Completed

NCT Number: NCT00781937

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

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).

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Key information

Conditions

Metabolism and Nutrition Disorder Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Winnipeg, Manitoba, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

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

Drug

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 29, 2008
Registry last updated
Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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