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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting

Short name SCALE™ IBT

NCTNCT02963935 (opens ClinicalTrials.gov in a new tab)Other idNN8022-4274Other idU1111-1177-5059
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
282 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
6 Feb 2017
Primary completion
23 May 2018
Completion
19 Jun 2018
First posted
15 Nov 2016 (estimated)
Last update posted
11 Mar 2020
Conditions
Metabolism and Nutrition Disorder · Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019
  1. Ph 3

    SCALE™ IBT

    NCT02963935

    6 Feb 2017 to 19 Jun 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • liraglutideDrug
  • placeboDrug
  • CMS Intensive Behavior TherapyBehavioral

Arms2

  • Experimental

    Liraglutide

  • Placebo comparator

    Placebo

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in Body Weight (%)

    Time frame · Week 0, week 56

    Registry 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.

  2. Proportion of Subjects Losing at Least 5% of Baseline Body Weight at Week 56

    Time frame · Week 56

    Registry 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.

Secondary outcomes(20)

  1. Proportion of Subjects Losing More Than 10% of Baseline Body Weight at Week 56

    Time frame · Week 56

    Registry 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.

  2. Proportion of Subjects Losing More Than 15% of Baseline Body Weight at Week 56

    Time frame · Week 56

    Registry 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.

  3. Proportion of Subjects Losing 4% or More of Baseline Body Weight

    Time frame · Week 16

    Registry 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).

  4. Change in Waist Circumference (cm)

    Time frame · Week 0, week 56

    Registry description

    Observed mean change from baseline in waist circumference. The endpoint was evaluated based on in-trial data and on-drug data.

  5. Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score

    Time frame · Week 0, week 56

    Registry 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.

  6. Change in IWQoL-Lite for CT, Physical Function Domain (5-items) Score

    Time frame · Week 0, week 56

    Registry 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.

  7. Change in Six Minutes Walking Distance Test (6MWT)

    Time frame · Week 0, week 56

    Registry 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.

  8. Change From Baseline in HbA1c (%)

    Time frame · Week 0, week 56

    Registry description

    Observed mean change from baseline to week 56 in glycosylated haemoglobin (HbA1c). Results based on FAS in-trial data is presented.

  9. Change From Baseline in FPG (mg/dL)

    Time frame · Week 0, week 56

    Registry description

    Observed mean change from baseline (week 0) in fasting plasma glucose (FPG). Results based on FAS in-trial data is presented.

  10. Change From Baseline sBP (mmHg)

    Time frame · Week 0, week 56

    Registry description

    Observed mean change in systolic blood pressure from baseline to week 56.

  11. Change From Baseline dBP (mmHg)

    Time frame · Week 0, week 56

    Registry 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.

  12. Change From Baseline in Lipids -Total Cholesterol

    Time frame · Week 0, week 56

    Registry description

    Observed mean change from baseline (week 0) to week 56 in total cholesterol (TC). Results based on FAS in-trial data is presented.

  13. Change From Baseline in Lipids - LDL Cholesterol

    Time frame · Week 0, week 56

    Registry 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.

  14. Change From Baseline in Lipids - HDL Cholesterol

    Time frame · Week 0, week 56

    Registry 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.

  15. Change From Baseline in Lipids - VLDL Cholesterol

    Time frame · Week 0, week 56

    Registry 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.

  16. Change From Baseline in Lipids - TG

    Time frame · Week 0, week 56

    Registry 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.

  17. Change From Baseline in Lipids - FFA

    Time frame · Week 0, week 56

    Registry 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.

  18. Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains)

    Time frame · Week 0, week 56

    Registry 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.

  19. Change in Short Form-36 v2.0 Acute (SF-36) (Physical Component Summary (PCS))

    Time frame · Week 0, week 56

    Registry 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.

  20. Change in Short Form-36 v2.0 Acute (SF-36) (Mental Component Summary (MCS)

    Time frame · Week 0, week 56

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Week 0, week 56

Change in Body Weight (%)

GroupValue (percent change)Spread
Liraglutide 3.0 mg-7.47.9
Placebo-4.07.4
Primary outcomeNumber· Week 56

Proportion of Subjects Losing at Least 5% of Baseline Body Weight at Week 56

GroupValue (percentage of participants)
Liraglutide 3.0 mg61.47
Placebo38.82
Secondary and other outcome results(6)
Secondary outcomeNumber· Week 56

Proportion of Subjects Losing More Than 10% of Baseline Body Weight at Week 56

GroupValue (percentage of participants)
Liraglutide 3.0 mg30.45
Placebo19.75
Secondary outcomeNumber· Week 56

Proportion of Subjects Losing More Than 15% of Baseline Body Weight at Week 56

GroupValue (percentage of participants)
Liraglutide 3.0 mg18.11
Placebo8.92
Secondary outcomeNumber· Week 16

Proportion of Subjects Losing 4% or More of Baseline Body Weight

GroupValue (percentage of participants)
Liraglutide 3.0 mg78.73
Placebo52.70
Secondary outcomeMean· Week 0, week 56

Change in Waist Circumference (cm)

GroupValue (cm)Spread
Liraglutide 3.0 mg-9.279.22
Placebo-6.918.22
Secondary outcomeMean· Week 0, week 56

Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score

GroupValue (Scores on a scale)Spread
Liraglutide 3.0 mg3.556.98
Placebo4.216.85
Secondary outcomeMean· Week 0, week 56

Change in IWQoL-Lite for CT, Physical Function Domain (5-items) Score

GroupValue (Scores on a scale)Spread
Liraglutide 3.0 mg13.521.4
Placebo15.523.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Lira 3.0 mgSubjects received liraglutide 3.0 mg once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Subjects received 0.6 mg liraglutide during the first week. The dose was escalated in weekly increments of 0.6 mg until they reached a maintenance dose of 3.0 mg after 4 weeks. The treatment period was 56 weeks. Subjects were also on CMS-IBT during the trial.0 / 1426 / 142124 / 142
PlaceboSubjects received matching placebo once daily by subcutaneous injection (in the abdomen, thigh or upper arm) irrespective of the timing of meals. Dose escalation for placebo matched that of liraglutide. Subjects remained on a stable dose of placebo for 56 weeks. Subjects were also on CMS-IBT during the trial.0 / 1402 / 140101 / 140

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2020

5 results

Liraglutide 3.0 mg and Intensive Behavioral Therapy (IBT) for Obesity in Primary Care: The SCALE IBT Randomized Controlled Trial.

Wadden et al. 2020Obesity (Silver Spring, Md.)cited by 154

PMID 32090517PMC7065111DOI 10.1002/oby.22726PUB-32090517

Free to read · publisher termsCC BY-NC-ND5 results
Read at sourceSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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