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

September 29, 2017 updated by: Novo Nordisk A/S

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

422

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 0, week 56
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.
Week 0, week 56
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.
Week 0, week 56

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Waist Circumference
Time Frame: Week 0, week 56
Week 0, week 56
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.
Week 0, week 56
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.
Week 0, week 56
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.
Week 0, week 56
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.
Week 0, week 56
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.
Week 0, week 56
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.
Week 0, week 56
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.
Week 0, week 68
Change From Baseline in Blood Pressure
Time Frame: Week 0, week 56
Week 0, week 56
Change From Baseline in Pulse
Time Frame: Week 0, week 56
Week 0, week 56
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.
Week 0, week 56
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.
Week 0, week 56
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.
Week 0, week 56
Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)
Time Frame: Week 0, week 56
Week 0, week 56
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.
Week 56
Change From Baseline in Body Mass Index (BMI)
Time Frame: Week 0, week 56
Week 0, week 56
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%.
Week 0, week 56
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.
Week 0, week 56
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.
Week 0, week 56
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.
Week 0, week 56
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%].
Week 0, week 56
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
Week 0 and week 56
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)
Week 0, week 50 and week 57

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 28, 2008

First Submitted That Met QC Criteria

October 28, 2008

First Posted (Estimate)

October 29, 2008

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8022-1923

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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