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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00781937
First received: October 28, 2008
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Metabolism and Nutrition Disorder
Obesity
Drug: liraglutide
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Mean Percentage Change in Fasting Body Weight From Baseline [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

  • Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0 [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0 [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.


Secondary Outcome Measures:
  • Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0 [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

  • Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0 [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

  • Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0 [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

  • Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0 [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

  • Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0 [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

  • Change From Baseline in Fasting Weight [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

  • 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 ] [ Designated as safety issue: No ]
    Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

  • Change From Baseline in Blood Pressure [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • Change From Baseline in Pulse [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • Change From Baseline in Fasting Lipid Profile: Triglycerides [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

  • Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

  • Change From Baseline in Fasting Lipid Profile: Total Cholesterol [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

  • Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP) [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56 [ Time Frame: Week 56 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Waist Circumference [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • Change From Baseline in Body Mass Index (BMI) [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
  • Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function) [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
    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%.

  • Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance) [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

  • Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
    Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

  • Change From Baseline in Glycaemic Control Parameter: HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 56 ] [ Designated as safety issue: No ]
    Change in HbA1c percent values from Week 0 (X%) to Week 56 (Y%) was calculated [X% - Y%].

  • Number of Subjects Using Concomitant Medications (Antihypertensive Medications, Lipid Lowering Medications, or Antipsychotic Medications) [ Time Frame: Week 0 and week 56 ] [ Designated as safety issue: No ]
    Number of subjects using concomitant medications at Week 0 and Week 56, respectively

  • Binge Eating Scale Scores by Week and Severity [ Time Frame: Week 0, week 50 and week 57 ] [ Designated as safety issue: No ]
    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)


Enrollment: 422
Study Start Date: October 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781937

  Show 27 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Paula M. Hale, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00781937     History of Changes
Other Study ID Numbers: NN8022-1923
Study First Received: October 28, 2008
Results First Received: September 1, 2011
Last Updated: June 26, 2012
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Weight Loss
Body Weight
Body Weight Changes
Signs and Symptoms
Glucagon-Like Peptide 1
Liraglutide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014