A Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Obese Children Aged 7 to 11 Years

Part of paid clinical trials in Anaheim, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT02696148
Phase
PHASE1
Status
Completed

Conditions

  • Metabolism and Nutrition Disorder
  • Obesity

Eligibility Criteria

Sex
ALL
Age
7 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    For subcutaneous (s.c., under the skin) injection once daily.
  • placebo — DRUG
    For subcutaneous (s.c., under the skin) injection once daily.

Study Details

This trial is conducted in the United States of America. The aim of this trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of liraglutide in obese children aged 7 to 11 years

Key Dates

Start date
Mar 14, 2016
Status verified
Mar 2019
Primary completion
Apr 13, 2017
Completion
Apr 13, 2017

Study Design

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

Arms

  • Experimental: Liraglutide
  • Placebo Comparator: Placebo

Primary Outcome Measure

Number of treatment emergent adverse events [ Time Frame: From the time of first dosing and until completion of follow-up visit (59-108 days after first dosing) ]

Locations (9)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteAnaheimCalifornia92801-
Novo Nordisk Investigational SiteNew HavenConnecticut06520-
Novo Nordisk Investigational SiteJacksonvilleFlorida32207-
Novo Nordisk Investigational SitePensacolaFlorida32504-
Novo Nordisk Investigational SiteAtlantaGeorgia30331-
Novo Nordisk Investigational SiteBuffaloNew York14203-
Novo Nordisk Investigational SiteMineolaNew York11501-
Novo Nordisk Investigational SitePittsburghPennsylvania15224-
Novo Nordisk Investigational SiteMemphisTennessee38119-

Find similar trials in Anaheim, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Novo Nordisk Investigational Site· Anaheim, CANovo Nordisk Investigational Site· New Haven, CTNovo Nordisk Investigational Site· Jacksonville, FLNovo Nordisk Investigational Site· Pensacola, FLNovo Nordisk Investigational Site· Atlanta, GANovo Nordisk Investigational Site· Buffalo, NY

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