Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting (SCALE™ IBT)
Primary Purpose
Metabolism and Nutrition Disorder, Obesity
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
liraglutide
placebo
CMS Intensive Behavior Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Metabolism and Nutrition Disorder
Eligibility Criteria
Inclusion Criteria:
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- BMI above or equal to 30 kg/m^2
- Male or female, age 18 years or older at the time of signing informed consent
Exclusion Criteria:
- HbA1c (glycosylated haemoglobin) above or equal to 6.5% (at screening visit), or diagnosis of type 1 or type 2 diabetes mellitus
- Recent history of cardiovascular disease (myocardial infarction or stroke within the past 6 months), severe congestive heart failure (NYHA class III, IV), or second degree or greater heart block
- Personal or family history of Medullary Thyroid Carcinoma (MTC), or Multiple Endocrine Neoplasia type 2 (MEN2)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)
- Use in past 90 days of medications known to induce significant weight loss (e.g., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics)
- History of pancreatitis (acute or chronic)
- History of major depressive disorder within the past 2 years
- Any lifetime history of a suicide attempt
- Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic above or equal to 180 mmHg or diastolic above or equal to 110 mmHg)
- History of malignancy (except for non-melanoma skin cancer) within the past 5 years
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Liraglutide
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in Body Weight (%)
Observed mean change in body weight from baseline (week 0) to week 56 was evaluated for two different observation periods. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which subjects are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).
The test of superiority of liraglutide to placebo for the treatment policy estimand was tested in a hierarchical manner for the two primary and the consequent 7 confirmatory secondary endpoints presented.
Proportion of Subjects Losing at Least 5% of Baseline Body Weight at Week 56
The estimated mean percentage of subjects losing at least 5% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data.
Secondary Outcome Measures
Proportion of Subjects Losing More Than 10% of Baseline Body Weight at Week 56
The estimated mean percentage of subjects losing more than 10% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data.
Proportion of Subjects Losing More Than 15% of Baseline Body Weight at Week 56
The estimated mean percentage of subjects losing more than 15% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data.
Proportion of Subjects Losing 4% or More of Baseline Body Weight
The estimated mean percentage of subjects losing 4% or more of baseline body weight at week 16 is presented. The endpoint was evaluated for treatment policy estimand (in-trial data).
Change in Waist Circumference (cm)
Observed mean change from baseline in waist circumference. The endpoint was evaluated based on in-trial data and on-drug data.
Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score
SF-36 is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL).
SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in SF-36 physical functioning score is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data.
Change in IWQoL-Lite for CT, Physical Function Domain (5-items) Score
Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trials Version (IWQoL-Lite for CT ) score. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life.
The endpoint was evaluated based on in-trial data and on-drug data.
Change in Six Minutes Walking Distance Test (6MWT)
Observed mean change from baseline in 6 minutes walking distance test. The 6MWT is a common test of functional exercise capacity that assesses the distance a subject can walk in 6 minutes. The endpoint was evaluated based on in-trial data and on-drug data.
Change From Baseline in HbA1c (%)
Observed mean change from baseline to week 56 in glycosylated haemoglobin (HbA1c). Results based on FAS in-trial data is presented.
Change From Baseline in FPG (mg/dL)
Observed mean change from baseline (week 0) in fasting plasma glucose (FPG). Results based on FAS in-trial data is presented.
Change From Baseline sBP (mmHg)
Observed mean change in systolic blood pressure from baseline to week 56.
Change From Baseline dBP (mmHg)
Observed mean change from baseline (week 0) to week 56 in diastolic blood pressure (dBP). Results based on FAS in-trial data is presented.
Change From Baseline in Lipids -Total Cholesterol
Observed mean change from baseline (week 0) to week 56 in total cholesterol (TC). Results based on FAS in-trial data is presented.
Change From Baseline in Lipids - LDL Cholesterol
Observed mean change from baseline in low density cholesterol (LDL) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.
Change From Baseline in Lipids - HDL Cholesterol
Observed mean change from baseline in high density (HDL) cholesterol from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.
Change From Baseline in Lipids - VLDL Cholesterol
Observed mean change from baseline in very low density cholesterol (VLDL) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.
Change From Baseline in Lipids - TG
Observed mean change from baseline in triglyceride (TG) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.
Change From Baseline in Lipids - FFA
Observed mean change from baseline in free fatty acids (FFA) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.
Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains)
SF-36 is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL).
SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in in the sub-domain scores is presented. A positive change score indicates an improvement since baseline. Results are evaluated based on in-trial data.
Change in Short Form-36 v2.0 Acute (SF-36) (Physical Component Summary (PCS))
Observed mean change from baseline (week 0) to week 56 in short form 36 v2.0 acute domain physical component summary (PCS). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in SF-36 physical component summary (PCS) score is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data.
Change in Short Form-36 v2.0 Acute (SF-36) (Mental Component Summary (MCS)
Observed mean change from baseline (week 0) to week 56 in short form 36 v2.0 acute domain mental component summary (MCS). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in SF-36 mental component summary is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data.
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Pain/Discomfort Domain Score
Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT) domain pain and discomfort. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. Results based on FAS in-trial data is presented.
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Psychosocial Domain Score
Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT) psychosocial domain. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. Results based on FAS in-trial data is presented.
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Total Score
Observed mean change from baseline (week 0) to week 56 in IWQoL-Lite for CT total score. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. Results based on FAS in-trial data is presented.
Change in Weight Related Sign and Symptom (WRSS) Measure, Total Score
Observed mean change from baseline (week 0) to week 56 in WRSS measure, total score. The WRSS measures the presence and bothersome associated with weight-related symptoms.
The WRSS questionnaire was not validated until after database lock. Therefore the total score couldn't be calculated and the supportive secondary endpoint "Weight related sign and symptom (WRSS) measure, total score" couldn't be analysed.
Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.3 T-score Points Increase From Baseline in SF-36 Physical Functioning Score
Percentage of subjects who achieved ≥ 4.3 T-score points increase from baseline in SF-36 physical functioning score at week 56 is presented. Results based on FAS in-trial data is presented.
Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 3.8 T-score Points Increase From Baseline in SF-36 Physical Component Score
Percentage of subjects who achieved ≥ 3.8 T-score points increase from baseline in SF-36 physical component score at week 56 is presented. Results based on FAS in-trial data is presented.
Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.6 T-score Points Increase From Baseline in SF-36 Mental Component Score
Percentage of subjects who achieved ≥ 4.6 T-score points increase from baseline in SF-36 mental component score at week 56 is presented. Results based on FAS in-trial data is presented.
Responder Definition Value for IWQoL-Lite for CT Physical Function Domain (5-items) Score
Responder definition value for IWQoL-Lite for CT physical function domain (5-items) score' was defined as '≥ 20 responder definition value for IWQoL-Lite for CT physical function domain (5-items) score. Percentage of subjects considered IWQoL-Lite for CT physical function domain score responders (increase of ≥20 points) at week 56 is presented. Results based on FAS in-trial data is presented.
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Trial Product
Adherence to trial product is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to trial product is presented.
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet
Adherence to caloric diet is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet is presented.
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Physical Activity
Adherence to physical activity is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to physical activity is presented.
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet and Physical Activity
Adherence to caloric diet and physical activity is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet and physical activity is presented.
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet, Physical Activity and Trial Product
Adherence to caloric diet, physical activity and trial product is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet, physical activity and trial product is presented.
AEs From Randomisation Until and Including the Follow-up Period
Number of adverse events from randomisation to until the end of the post-treatment follow-up period (30 days). Results based on SAS on-drug data is presented.
Change in Physical Examination
Observed change from baseline to week 56 in physical examination are categorised under parameters namely abdomen, gastrointestinal system, cardiovascular system, central and peripheral nervous system, general appearence, head, ears, eyes, nose, throat and neck, lymph node palpation, musculoskeletal system, respiratory system, skin and thyroid gland. The percentage of subjects assessed as normal, abnormal not clinically significant and abnormal clinically significant at baseline and week 56 is presented.
Change in Resting Pulse
Observed mean change in pulse rate measured at resting position is presented.
Change in ECG
The ECGs were interpreted by the investigator at baseline (week -1) and week 56 and categorised as normal, abnormal NCS or abnormal CS. Number of subjects in each ECG category at baseline and week 56 are presented.
Change in Laboratory Measurements: Haematology (Haemoglobin Blood)
Observed mean change from baseline in haematological parameter blood haemoglobin.
Change in Laboratory Measurements: Haematology (Haematocrit Blood)
Observed mean change from baseline in haematological parameter blood haematocrit. Haematocrit is presented as the percentage of red blood cells in total blood. Results based on SAS on-drug data is presented.
Change in Laboratory Measurements: Haematology (Erythrocytes)
Observed mean change from baseline in haematological parameter - erythrocytes.
Change in Laboratory Measurements: Haematology (Thrombocytes and Leukocytes)
Observed mean change from baseline in haematological parameters - thrombocytss and leukocytes.
Change in Laboratory Measurements: Biochemistry (Albumin)
Observed mean change from baseline in biochemical parameter - albumin. Results based on SAS on-drug data is presented.
Change in Laboratory Measurements: Biochemistry (Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase)
Observed mean change from baseline in biochemical parameters - alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase and lipase. Results based on SAS on-drug data is presented.
Change in Laboratory Measurements: Biochemistry (Bilirubin and Creatinine)
Observed mean change from baseline in biochemical parameters - bilirubin and creatinine. Results based on SAS on-drug data is presented.
Change in Laboratory Measurements: Biochemistry (Total Calcium, Pottassium, Sodium and Urea)
Observed mean change from baseline in biochemical parameters - total calcium, pottassium, sodium and urea. Results based on SAS on-drug data is presented.
Change in Laboratory Measurements: Biochemistry (C-reactive Protein and Uric Acid)
Observed mean change from baseline in biochemical parameters - high sensitive c-reactive protein and uric acid. Results based on SAS on-drug data is presented.
Change in Laboratory Measurements: Biochemistry (Glomerular Filtration Rate, Serum)
Observed mean change from baseline in biochemical parameters - estimated glomerular filtration rate. Serum GFR is estimated using MDRD formula . Results based on SAS on-drug data is presented.
Change in Laboratory Measurements: Biochemistry (Calcitonin)
Observed mean change from baseline in biochemical parameter - calcitonin. Results based on SAS on-drug data is presented.
Change in Laboratory Measurements: Biochemistry (Thyroid Stimulating Hormone)
Observed mean change from baseline in biochemical parameters - thyroid stimulating hormone. Results based on SAS on-drug data is presented.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02963935
Brief Title
Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting
Acronym
SCALE™ IBT
Official Title
Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 6, 2017 (Actual)
Primary Completion Date
May 23, 2018 (Actual)
Study Completion Date
June 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This trial is conducted in the United States of America (USA). The purpose of the trial is to investigate the effect and safety of liraglutide 3.0 mg as an adjunct to intensive behaviour therapy for obesity in a non-specialist setting (IBT-CMS: Intensive Behaviour Therapy for obesity in a primary care setting according to Centers for Medicare & Medicaid Services (CMS) visit schedule).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism and Nutrition Disorder, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
282 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liraglutide
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg
Intervention Type
Behavioral
Intervention Name(s)
CMS Intensive Behavior Therapy
Intervention Description
Intensive Behaviour Therapy for obesity
Primary Outcome Measure Information:
Title
Change in Body Weight (%)
Description
Observed mean change in body weight from baseline (week 0) to week 56 was evaluated for two different observation periods. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which subjects are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).
The test of superiority of liraglutide to placebo for the treatment policy estimand was tested in a hierarchical manner for the two primary and the consequent 7 confirmatory secondary endpoints presented.
Time Frame
Week 0, week 56
Title
Proportion of Subjects Losing at Least 5% of Baseline Body Weight at Week 56
Description
The estimated mean percentage of subjects losing at least 5% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data.
Time Frame
Week 56
Secondary Outcome Measure Information:
Title
Proportion of Subjects Losing More Than 10% of Baseline Body Weight at Week 56
Description
The estimated mean percentage of subjects losing more than 10% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data.
Time Frame
Week 56
Title
Proportion of Subjects Losing More Than 15% of Baseline Body Weight at Week 56
Description
The estimated mean percentage of subjects losing more than 15% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data.
Time Frame
Week 56
Title
Proportion of Subjects Losing 4% or More of Baseline Body Weight
Description
The estimated mean percentage of subjects losing 4% or more of baseline body weight at week 16 is presented. The endpoint was evaluated for treatment policy estimand (in-trial data).
Time Frame
Week 16
Title
Change in Waist Circumference (cm)
Description
Observed mean change from baseline in waist circumference. The endpoint was evaluated based on in-trial data and on-drug data.
Time Frame
Week 0, week 56
Title
Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score
Description
SF-36 is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL).
SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in SF-36 physical functioning score is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data.
Time Frame
Week 0, week 56
Title
Change in IWQoL-Lite for CT, Physical Function Domain (5-items) Score
Description
Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trials Version (IWQoL-Lite for CT ) score. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life.
The endpoint was evaluated based on in-trial data and on-drug data.
Time Frame
Week 0, week 56
Title
Change in Six Minutes Walking Distance Test (6MWT)
Description
Observed mean change from baseline in 6 minutes walking distance test. The 6MWT is a common test of functional exercise capacity that assesses the distance a subject can walk in 6 minutes. The endpoint was evaluated based on in-trial data and on-drug data.
Time Frame
Week 0, week 56
Title
Change From Baseline in HbA1c (%)
Description
Observed mean change from baseline to week 56 in glycosylated haemoglobin (HbA1c). Results based on FAS in-trial data is presented.
Time Frame
Week 0, week 56
Title
Change From Baseline in FPG (mg/dL)
Description
Observed mean change from baseline (week 0) in fasting plasma glucose (FPG). Results based on FAS in-trial data is presented.
Time Frame
Week 0, week 56
Title
Change From Baseline sBP (mmHg)
Description
Observed mean change in systolic blood pressure from baseline to week 56.
Time Frame
Week 0, week 56
Title
Change From Baseline dBP (mmHg)
Description
Observed mean change from baseline (week 0) to week 56 in diastolic blood pressure (dBP). Results based on FAS in-trial data is presented.
Time Frame
Week 0, week 56
Title
Change From Baseline in Lipids -Total Cholesterol
Description
Observed mean change from baseline (week 0) to week 56 in total cholesterol (TC). Results based on FAS in-trial data is presented.
Time Frame
Week 0, week 56
Title
Change From Baseline in Lipids - LDL Cholesterol
Description
Observed mean change from baseline in low density cholesterol (LDL) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.
Time Frame
Week 0, week 56
Title
Change From Baseline in Lipids - HDL Cholesterol
Description
Observed mean change from baseline in high density (HDL) cholesterol from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.
Time Frame
Week 0, week 56
Title
Change From Baseline in Lipids - VLDL Cholesterol
Description
Observed mean change from baseline in very low density cholesterol (VLDL) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.
Time Frame
Week 0, week 56
Title
Change From Baseline in Lipids - TG
Description
Observed mean change from baseline in triglyceride (TG) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.
Time Frame
Week 0, week 56
Title
Change From Baseline in Lipids - FFA
Description
Observed mean change from baseline in free fatty acids (FFA) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.
Time Frame
Week 0, week 56
Title
Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains)
Description
SF-36 is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL).
SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in in the sub-domain scores is presented. A positive change score indicates an improvement since baseline. Results are evaluated based on in-trial data.
Time Frame
Week 0, week 56
Title
Change in Short Form-36 v2.0 Acute (SF-36) (Physical Component Summary (PCS))
Description
Observed mean change from baseline (week 0) to week 56 in short form 36 v2.0 acute domain physical component summary (PCS). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in SF-36 physical component summary (PCS) score is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data.
Time Frame
Week 0, week 56
Title
Change in Short Form-36 v2.0 Acute (SF-36) (Mental Component Summary (MCS)
Description
Observed mean change from baseline (week 0) to week 56 in short form 36 v2.0 acute domain mental component summary (MCS). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in SF-36 mental component summary is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data.
Time Frame
Week 0, week 56
Title
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Pain/Discomfort Domain Score
Description
Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT) domain pain and discomfort. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. Results based on FAS in-trial data is presented.
Time Frame
Week 0, week 56
Title
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Psychosocial Domain Score
Description
Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT) psychosocial domain. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. Results based on FAS in-trial data is presented.
Time Frame
Week 0, week 56
Title
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Total Score
Description
Observed mean change from baseline (week 0) to week 56 in IWQoL-Lite for CT total score. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. Results based on FAS in-trial data is presented.
Time Frame
Week 0, week 56
Title
Change in Weight Related Sign and Symptom (WRSS) Measure, Total Score
Description
Observed mean change from baseline (week 0) to week 56 in WRSS measure, total score. The WRSS measures the presence and bothersome associated with weight-related symptoms.
The WRSS questionnaire was not validated until after database lock. Therefore the total score couldn't be calculated and the supportive secondary endpoint "Weight related sign and symptom (WRSS) measure, total score" couldn't be analysed.
Time Frame
Week 0, week 56
Title
Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.3 T-score Points Increase From Baseline in SF-36 Physical Functioning Score
Description
Percentage of subjects who achieved ≥ 4.3 T-score points increase from baseline in SF-36 physical functioning score at week 56 is presented. Results based on FAS in-trial data is presented.
Time Frame
Week 56
Title
Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 3.8 T-score Points Increase From Baseline in SF-36 Physical Component Score
Description
Percentage of subjects who achieved ≥ 3.8 T-score points increase from baseline in SF-36 physical component score at week 56 is presented. Results based on FAS in-trial data is presented.
Time Frame
Week 56
Title
Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.6 T-score Points Increase From Baseline in SF-36 Mental Component Score
Description
Percentage of subjects who achieved ≥ 4.6 T-score points increase from baseline in SF-36 mental component score at week 56 is presented. Results based on FAS in-trial data is presented.
Time Frame
Week 56
Title
Responder Definition Value for IWQoL-Lite for CT Physical Function Domain (5-items) Score
Description
Responder definition value for IWQoL-Lite for CT physical function domain (5-items) score' was defined as '≥ 20 responder definition value for IWQoL-Lite for CT physical function domain (5-items) score. Percentage of subjects considered IWQoL-Lite for CT physical function domain score responders (increase of ≥20 points) at week 56 is presented. Results based on FAS in-trial data is presented.
Time Frame
Week 56
Title
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Trial Product
Description
Adherence to trial product is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to trial product is presented.
Time Frame
Week 0, week 56
Title
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet
Description
Adherence to caloric diet is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet is presented.
Time Frame
Week 0, week 56
Title
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Physical Activity
Description
Adherence to physical activity is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to physical activity is presented.
Time Frame
Week 0, week 56
Title
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet and Physical Activity
Description
Adherence to caloric diet and physical activity is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet and physical activity is presented.
Time Frame
Week 0, week 56
Title
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet, Physical Activity and Trial Product
Description
Adherence to caloric diet, physical activity and trial product is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet, physical activity and trial product is presented.
Time Frame
Week 0, week 56
Title
AEs From Randomisation Until and Including the Follow-up Period
Description
Number of adverse events from randomisation to until the end of the post-treatment follow-up period (30 days). Results based on SAS on-drug data is presented.
Time Frame
Week 0 to week 56+30 days
Title
Change in Physical Examination
Description
Observed change from baseline to week 56 in physical examination are categorised under parameters namely abdomen, gastrointestinal system, cardiovascular system, central and peripheral nervous system, general appearence, head, ears, eyes, nose, throat and neck, lymph node palpation, musculoskeletal system, respiratory system, skin and thyroid gland. The percentage of subjects assessed as normal, abnormal not clinically significant and abnormal clinically significant at baseline and week 56 is presented.
Time Frame
Week 1, week 56
Title
Change in Resting Pulse
Description
Observed mean change in pulse rate measured at resting position is presented.
Time Frame
Week 0, week 56
Title
Change in ECG
Description
The ECGs were interpreted by the investigator at baseline (week -1) and week 56 and categorised as normal, abnormal NCS or abnormal CS. Number of subjects in each ECG category at baseline and week 56 are presented.
Time Frame
Week -1, week 56
Title
Change in Laboratory Measurements: Haematology (Haemoglobin Blood)
Description
Observed mean change from baseline in haematological parameter blood haemoglobin.
Time Frame
Week 0, week 56
Title
Change in Laboratory Measurements: Haematology (Haematocrit Blood)
Description
Observed mean change from baseline in haematological parameter blood haematocrit. Haematocrit is presented as the percentage of red blood cells in total blood. Results based on SAS on-drug data is presented.
Time Frame
Week 0, week 56
Title
Change in Laboratory Measurements: Haematology (Erythrocytes)
Description
Observed mean change from baseline in haematological parameter - erythrocytes.
Time Frame
Week 0, week 56
Title
Change in Laboratory Measurements: Haematology (Thrombocytes and Leukocytes)
Description
Observed mean change from baseline in haematological parameters - thrombocytss and leukocytes.
Time Frame
Week 0, week 56
Title
Change in Laboratory Measurements: Biochemistry (Albumin)
Description
Observed mean change from baseline in biochemical parameter - albumin. Results based on SAS on-drug data is presented.
Time Frame
Week 0, week 56
Title
Change in Laboratory Measurements: Biochemistry (Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase)
Description
Observed mean change from baseline in biochemical parameters - alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase and lipase. Results based on SAS on-drug data is presented.
Time Frame
Week 0, week 56
Title
Change in Laboratory Measurements: Biochemistry (Bilirubin and Creatinine)
Description
Observed mean change from baseline in biochemical parameters - bilirubin and creatinine. Results based on SAS on-drug data is presented.
Time Frame
Week 0, week 56
Title
Change in Laboratory Measurements: Biochemistry (Total Calcium, Pottassium, Sodium and Urea)
Description
Observed mean change from baseline in biochemical parameters - total calcium, pottassium, sodium and urea. Results based on SAS on-drug data is presented.
Time Frame
Week 0, week 56
Title
Change in Laboratory Measurements: Biochemistry (C-reactive Protein and Uric Acid)
Description
Observed mean change from baseline in biochemical parameters - high sensitive c-reactive protein and uric acid. Results based on SAS on-drug data is presented.
Time Frame
Week 0, week 56
Title
Change in Laboratory Measurements: Biochemistry (Glomerular Filtration Rate, Serum)
Description
Observed mean change from baseline in biochemical parameters - estimated glomerular filtration rate. Serum GFR is estimated using MDRD formula . Results based on SAS on-drug data is presented.
Time Frame
Week 0, week 56
Title
Change in Laboratory Measurements: Biochemistry (Calcitonin)
Description
Observed mean change from baseline in biochemical parameter - calcitonin. Results based on SAS on-drug data is presented.
Time Frame
Week 0, week 56
Title
Change in Laboratory Measurements: Biochemistry (Thyroid Stimulating Hormone)
Description
Observed mean change from baseline in biochemical parameters - thyroid stimulating hormone. Results based on SAS on-drug data is presented.
Time Frame
Week 0, week 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
BMI above or equal to 30 kg/m^2
Male or female, age 18 years or older at the time of signing informed consent
Exclusion Criteria:
HbA1c (glycosylated haemoglobin) above or equal to 6.5% (at screening visit), or diagnosis of type 1 or type 2 diabetes mellitus
Recent history of cardiovascular disease (myocardial infarction or stroke within the past 6 months), severe congestive heart failure (NYHA class III, IV), or second degree or greater heart block
Personal or family history of Medullary Thyroid Carcinoma (MTC), or Multiple Endocrine Neoplasia type 2 (MEN2)
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)
Use in past 90 days of medications known to induce significant weight loss (e.g., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics)
History of pancreatitis (acute or chronic)
History of major depressive disorder within the past 2 years
Any lifetime history of a suicide attempt
Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic above or equal to 180 mmHg or diastolic above or equal to 110 mmHg)
History of malignancy (except for non-melanoma skin cancer) within the past 5 years
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-3317
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22206
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com/
Citations:
PubMed Identifier
32090517
Citation
Wadden TA, Tronieri JS, Sugimoto D, Lund MT, Auerbach P, Jensen C, Rubino D. Liraglutide 3.0 mg and Intensive Behavioral Therapy (IBT) for Obesity in Primary Care: The SCALE IBT Randomized Controlled Trial. Obesity (Silver Spring). 2020 Mar;28(3):529-536. doi: 10.1002/oby.22726.
Results Reference
result
Learn more about this trial
Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting
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