Metabolism and Nutrition DisorderPhase 3SCALE™ IBTNCT02963935
Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting
A Phase 3 study testing liraglutide and CMS Intensive Behavior Therapy in people with Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 10 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolism and Nutrition Disorder, Obesity
- What is being tested?
- liraglutide and CMS Intensive Behavior Therapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- 10 sitesUnited States
- Study dates
- 6 Feb 2017to 19 Jun 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Novo Nordisk Investigational Site
Arlington, Virginia, 22206
Novo Nordisk Investigational Site
Charleston, South Carolina, 29425
Novo Nordisk Investigational Site
Chicago, Illinois, 60607
Novo Nordisk Investigational Site
Dallas, Texas, 75251
Novo Nordisk Investigational Site
Greensboro, North Carolina, 27408
Novo Nordisk Investigational Site
Jacksonville, Florida, 32205
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19104-3317
Novo Nordisk Investigational Site
Plantation, Florida, 33324
Novo Nordisk Investigational Site
Salisbury, North Carolina, 28144
Novo Nordisk Investigational Site
Wadsworth, Ohio, 44281
About this study
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).
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Being tested
- liraglutide, placebo, CMS Intensive Behavior Therapy
- Medical subject headings
- Nutrition Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg
placeboDrug
Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg
CMS Intensive Behavior TherapyBehavioural
Intensive Behaviour Therapy for obesity
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide | Experimental | Not described Receives: Drug: liraglutide; Behavioral: CMS Intensive Behavior Therapy |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo; Behavioral: CMS Intensive Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0, week 56
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.
Measured: Week 56
Secondary outcomes (49)
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.
Measured: Week 56
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.
Measured: Week 56
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).
Measured: Week 16
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
Change From Baseline sBP (mmHg)
Observed mean change in systolic blood pressure from baseline to week 56.
Measured: Week 0, 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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 56
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.
Measured: Week 56
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.
Measured: Week 56
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.
Measured: Week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0 to week 56+30 days
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.
Measured: Week 1, week 56
Change in Resting Pulse
Observed mean change in pulse rate measured at resting position is presented.
Measured: Week 0, week 56
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.
Measured: Week -1, week 56
Change in Laboratory Measurements: Haematology (Haemoglobin Blood)
Observed mean change from baseline in haematological parameter blood haemoglobin.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
Change in Laboratory Measurements: Haematology (Erythrocytes)
Observed mean change from baseline in haematological parameter - erythrocytes.
Measured: Week 0, week 56
Change in Laboratory Measurements: Haematology (Thrombocytes and Leukocytes)
Observed mean change from baseline in haematological parameters - thrombocytss and leukocytes.
Measured: Week 0, week 56
Change in Laboratory Measurements: Biochemistry (Albumin)
Observed mean change from baseline in biochemical parameter - albumin. Results based on SAS on-drug data is presented.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
Change in Laboratory Measurements: Biochemistry (Calcitonin)
Observed mean change from baseline in biochemical parameter - calcitonin. Results based on SAS on-drug data is presented.
Measured: Week 0, week 56
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.
Measured: Week 0, week 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study start6 Feb 2017
- Primary completion23 May 2018
- Study completion19 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolism and Nutrition DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963935
- Sponsor's protocol ID
- NN8022-4274
- Other IDs
- U1111-1177-5059
- Acronym
- SCALE™ IBT
- Status last verified
- Feb 2020
- First submitted
- 10 Nov 2016
- Last updated
- 11 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
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.
PubMed 32090517
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting
- ClinicalTrials.gov ID
- NCT02963935
- Acronym / sponsor ID
- SCALE™ IBT / NN8022-4274
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 23 May 2018 (actual)
- Study completion
- 19 Jun 2018 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Posted 30 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide | Experimental | Drug: liraglutide, Behavioral: CMS Intensive Behavior Therapy |
| Placebo | Placebo comparator | Drug: placebo, Behavioral: CMS Intensive Behavior Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liraglutideAdministered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg | Drug | Liraglutide |
| placeboAdministered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg | Drug | Placebo |
| CMS Intensive Behavior TherapyIntensive Behaviour Therapy for obesity | Behavioural | Liraglutide, Placebo |
Primary outcome
Change in Body Weight (%)
Time frame: Week 0, week 56
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
Time frame: 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.
49 secondary outcomes
Proportion of Subjects Losing More Than 10% of Baseline Body Weight at Week 56
Time frame: Week 56
Proportion of Subjects Losing More Than 15% of Baseline Body Weight at Week 56
Time frame: Week 56
Proportion of Subjects Losing 4% or More of Baseline Body Weight
Time frame: Week 16
Change in Waist Circumference (cm)
Time frame: Week 0, week 56
Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score
Time frame: Week 0, week 56
Change in IWQoL-Lite for CT, Physical Function Domain (5-items) Score
Time frame: Week 0, week 56
Change in Six Minutes Walking Distance Test (6MWT)
Time frame: Week 0, week 56
Change From Baseline in HbA1c (%)
Time frame: Week 0, week 56
Change From Baseline in FPG (mg/dL)
Time frame: Week 0, week 56
Change From Baseline sBP (mmHg)
Time frame: Week 0, week 56
Change From Baseline dBP (mmHg)
Time frame: Week 0, week 56
Change From Baseline in Lipids -Total Cholesterol
Time frame: Week 0, week 56
Change From Baseline in Lipids - LDL Cholesterol
Time frame: Week 0, week 56
Change From Baseline in Lipids - HDL Cholesterol
Time frame: Week 0, week 56
Change From Baseline in Lipids - VLDL Cholesterol
Time frame: Week 0, week 56
Change From Baseline in Lipids - TG
Time frame: Week 0, week 56
Change From Baseline in Lipids - FFA
Time frame: Week 0, week 56
Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains)
Time frame: Week 0, week 56
Change in Short Form-36 v2.0 Acute (SF-36) (Physical Component Summary (PCS))
Time frame: Week 0, week 56
Change in Short Form-36 v2.0 Acute (SF-36) (Mental Component Summary (MCS)
Time frame: Week 0, week 56
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Pain/Discomfort Domain Score
Time frame: Week 0, week 56
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Psychosocial Domain Score
Time frame: Week 0, week 56
Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Total Score
Time frame: Week 0, week 56
Change in Weight Related Sign and Symptom (WRSS) Measure, Total Score
Time frame: Week 0, week 56
Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.3 T-score Points Increase From Baseline in SF-36 Physical Functioning Score
Time frame: Week 56
Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 3.8 T-score Points Increase From Baseline in SF-36 Physical Component Score
Time frame: Week 56
Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.6 T-score Points Increase From Baseline in SF-36 Mental Component Score
Time frame: Week 56
Responder Definition Value for IWQoL-Lite for CT Physical Function Domain (5-items) Score
Time frame: Week 56
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Trial Product
Time frame: Week 0, week 56
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet
Time frame: Week 0, week 56
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Physical Activity
Time frame: Week 0, week 56
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet and Physical Activity
Time frame: Week 0, week 56
Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet, Physical Activity and Trial Product
Time frame: Week 0, week 56
AEs From Randomisation Until and Including the Follow-up Period
Time frame: Week 0 to week 56+30 days
Change in Physical Examination
Time frame: Week 1, week 56
Change in Resting Pulse
Time frame: Week 0, week 56
Change in ECG
Time frame: Week -1, week 56
Change in Laboratory Measurements: Haematology (Haemoglobin Blood)
Time frame: Week 0, week 56
Change in Laboratory Measurements: Haematology (Haematocrit Blood)
Time frame: Week 0, week 56
Change in Laboratory Measurements: Haematology (Erythrocytes)
Time frame: Week 0, week 56
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32090517Wadden 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.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing liraglutide and CMS Intensive Behavior Therapy in people with Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (%) (time frame: Week 0, week 56). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02963935, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.