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

Last updated: February 28, 2020
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Obesity

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT02963935
NN8022-4274
U1111-1177-5059
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. Trial-relatedactivities are any procedures that are carried out as part of the trial, includingactivities 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

Exclusion Criteria:

  • HbA1c (glycosylated haemoglobin) above or equal to 6.5% (at screening visit), ordiagnosis of type 1 or type 2 diabetes mellitus

  • Recent history of cardiovascular disease (myocardial infarction or stroke within thepast 6 months), severe congestive heart failure (NYHA class III, IV), or second degreeor greater heart block

  • Personal or family history of Medullary Thyroid Carcinoma (MTC), or Multiple EndocrineNeoplasia type 2 (MEN2)

  • Female who is pregnant, breast-feeding or intends to become pregnant or is ofchild-bearing potential and not using an adequate contraceptive method (adequatecontraceptive 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 oralsteroids, 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

Study Design

Total Participants: 282
Study Start date:
February 06, 2017
Estimated Completion Date:
June 19, 2018

Connect with a study center

  • Novo Nordisk Investigational Site

    Anaheim, California 92801
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Jacksonville, Florida 32205
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Plantation, Florida 33324
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    North Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Butte, Montana 59701
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greensboro, North Carolina 27408
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Wadsworth, Ohio 44281
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Philadelphia, Pennsylvania 19104-3317
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Greer, South Carolina 29651
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Dallas, Texas 75251
    United States

    Site Not Available

  • Novo Nordisk Investigational Site

    Arlington, Virginia 22206
    United States

    Site Not Available

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