Clinical trial NCT02963935: Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-11-15
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change in Body Weight (%)
timeFrame: Week 0, week 56
measure: Proportion of Subjects Losing at Least 5% of Baseline Body Weight at Week 56
timeFrame: Week 56
Secondary outcomes:
measure: Proportion of Subjects Losing More Than 10% of Baseline Body Weight at Week 56
timeFrame: Week 56
measure: Proportion of Subjects Losing More Than 15% of Baseline Body Weight at Week 56
timeFrame: Week 56
measure: Proportion of Subjects Losing 4% or More of Baseline Body Weight
timeFrame: Week 16
measure: Change in Waist Circumference (cm)
timeFrame: Week 0, week 56
measure: Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score
timeFrame: Week 0, week 56
measure: Change in IWQoL-Lite for CT, Physical Function Domain (5-items) Score
timeFrame: Week 0, week 56
measure: Change in Six Minutes Walking Distance Test (6MWT)
timeFrame: Week 0, week 56
measure: Change From Baseline in HbA1c (%)
timeFrame: Week 0, week 56
measure: Change From Baseline in FPG (mg/dL)
timeFrame: Week 0, week 56
measure: Change From Baseline sBP (mmHg)
timeFrame: Week 0, week 56
measure: Change From Baseline dBP (mmHg)
timeFrame: Week 0, week 56
measure: Change From Baseline in Lipids -Total Cholesterol
timeFrame: Week 0, week 56
measure: Change From Baseline in Lipids - LDL Cholesterol
timeFrame: Week 0, week 56
measure: Change From Baseline in Lipids - HDL Cholesterol
timeFrame: Week 0, week 56
measure: Change From Baseline in Lipids - VLDL Cholesterol
timeFrame: Week 0, week 56
measure: Change From Baseline in Lipids - TG
timeFrame: Week 0, week 56
measure: Change From Baseline in Lipids - FFA
timeFrame: Week 0, week 56
measure: Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains)
timeFrame: Week 0, week 56
measure: Change in Short Form-36 v2.0 Acute (SF-36) (Physical Component Summary (PCS))
timeFrame: Week 0, week 56
measure: Change in Short Form-36 v2.0 Acute (SF-36) (Mental Component Summary (MCS)
timeFrame: Week 0, week 56
measure: Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Pain/Discomfort Domain Score
timeFrame: Week 0, week 56
measure: Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Psychosocial Domain Score
timeFrame: Week 0, week 56
measure: Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Total Score
timeFrame: Week 0, week 56
measure: Change in Weight Related Sign and Symptom (WRSS) Measure, Total Score
timeFrame: Week 0, week 56
measure: Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.3 T-score Points Increase From Baseline in SF-36 Physical Functioning Score
timeFrame: Week 56
measure: Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 3.8 T-score Points Increase From Baseline in SF-36 Physical Component Score
timeFrame: Week 56
measure: Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.6 T-score Points Increase From Baseline in SF-36 Mental Component Score
timeFrame: Week 56
measure: Responder Definition Value for IWQoL-Lite for CT Physical Function Domain (5-items) Score
timeFrame: Week 56
measure: Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Trial Product
timeFrame: Week 0, week 56
measure: Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet
timeFrame: Week 0, week 56
measure: Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Physical Activity
timeFrame: Week 0, week 56
measure: Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet and Physical Activity
timeFrame: Week 0, week 56
measure: Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet, Physical Activity and Trial Product
timeFrame: Week 0, week 56
measure: AEs From Randomisation Until and Including the Follow-up Period
timeFrame: Week 0 to week 56+30 days
measure: Change in Physical Examination
timeFrame: Week 1, week 56
measure: Change in Resting Pulse
timeFrame: Week 0, week 56
measure: Change in ECG
timeFrame: Week -1, week 56
measure: Change in Laboratory Measurements: Haematology (Haemoglobin Blood)
timeFrame: Week 0, week 56
measure: Change in Laboratory Measurements: Haematology (Haematocrit Blood)
timeFrame: Week 0, week 56
measure: Change in Laboratory Measurements: Haematology (Erythrocytes)
timeFrame: Week 0, week 56
measure: Change in Laboratory Measurements: Haematology (Thrombocytes and Leukocytes)
timeFrame: Week 0, week 56
measure: Change in Laboratory Measurements: Biochemistry (Albumin)
timeFrame: Week 0, week 56
measure: Change in Laboratory Measurements: Biochemistry (Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase)
timeFrame: Week 0, week 56
measure: Change in Laboratory Measurements: Biochemistry (Bilirubin and Creatinine)
timeFrame: Week 0, week 56
measure: Change in Laboratory Measurements: Biochemistry (Total Calcium, Pottassium, Sodium and Urea)
timeFrame: Week 0, week 56
measure: Change in Laboratory Measurements: Biochemistry (C-reactive Protein and Uric Acid)
timeFrame: Week 0, week 56
measure: Change in Laboratory Measurements: Biochemistry (Glomerular Filtration Rate, Serum)
timeFrame: Week 0, week 56
measure: Change in Laboratory Measurements: Biochemistry (Calcitonin)
timeFrame: Week 0, week 56
measure: Change in Laboratory Measurements: Biochemistry (Thyroid Stimulating Hormone)
timeFrame: Week 0, week 56
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Plantation
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Greensboro
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Wadsworth
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Arlington
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
Study officials:
References:
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.