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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Novo Nordisk A/S
Study ID
NCT02963935
Phase
PHASE3
Status
Completed

Conditions

  • Metabolism and Nutrition Disorder
  • Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg
  • placebo — DRUG
    Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg
  • CMS Intensive Behavior Therapy — BEHAVIORAL
    Intensive Behaviour Therapy for obesity

Study Details

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).

Key Dates

Start date
Feb 6, 2017
Status verified
Feb 2020
Primary completion
May 23, 2018
Completion
Jun 19, 2018

Study Design

Enrollment
282 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in Body Weight (%) [ Time Frame: Week 0, week 56 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteJacksonvilleFlorida32205-
Novo Nordisk Investigational SitePlantationFlorida33324-
Novo Nordisk Investigational SiteChicagoIllinois60607-
Novo Nordisk Investigational SiteGreensboroNorth Carolina27408-
Novo Nordisk Investigational SiteSalisburyNorth Carolina28144-
Novo Nordisk Investigational SiteWadsworthOhio44281-
Novo Nordisk Investigational SitePhiladelphiaPennsylvania19104-3317-
Novo Nordisk Investigational SiteCharlestonSouth Carolina29425-
Novo Nordisk Investigational SiteDallasTexas75251-
Novo Nordisk Investigational SiteArlingtonVirginia22206-

Find similar trials in Jacksonville, FL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Novo Nordisk Investigational Site· Jacksonville, FLNovo Nordisk Investigational Site· Plantation, FLNovo Nordisk Investigational Site· Chicago, ILNovo Nordisk Investigational Site· Greensboro, NCNovo Nordisk Investigational Site· Salisbury, NCNovo Nordisk Investigational Site· Wadsworth, OH

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