Effect and Safety of Liraglutide 3.0 mg as an Adjunct to Intensive Behaviour Therapy for Obesity in a Non-specialist Setting
NCT ID: NCT02963935
Last Updated: 2020-03-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
282 participants
INTERVENTIONAL
2017-02-06
2018-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Liraglutide
liraglutide
Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg
CMS Intensive Behavior Therapy
Intensive Behaviour Therapy for obesity
Placebo
placebo
Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg
CMS Intensive Behavior Therapy
Intensive Behaviour Therapy for obesity
Interventions
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liraglutide
Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg
placebo
Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg
CMS Intensive Behavior Therapy
Intensive Behaviour Therapy for obesity
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Locations
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Novo Nordisk Investigational Site
Jacksonville, Florida, United States
Novo Nordisk Investigational Site
Plantation, Florida, United States
Novo Nordisk Investigational Site
Chicago, Illinois, United States
Novo Nordisk Investigational Site
Greensboro, North Carolina, United States
Novo Nordisk Investigational Site
Salisbury, North Carolina, United States
Novo Nordisk Investigational Site
Wadsworth, Ohio, United States
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States
Novo Nordisk Investigational Site
Charleston, South Carolina, United States
Novo Nordisk Investigational Site
Dallas, Texas, United States
Novo Nordisk Investigational Site
Arlington, Virginia, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1177-5059
Identifier Type: OTHER
Identifier Source: secondary_id
NN8022-4274
Identifier Type: -
Identifier Source: org_study_id
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