Impact of Liraglutide 3.0 on Body Fat Distribution

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT03038620
Phase
PHASE4
Status
Completed

Conditions

  • Cardiovascular Diseases
  • Fat Disorder
  • Obesity, Visceral

Eligibility Criteria

Sex
ALL
Age
35 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Liraglutide — DRUG
    Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
  • Placebo — DRUG
    Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.

Study Details

This study is a clinical study to investigate the efficacy of liraglutide compared to placebo in reducing visceral adiposity measured by MRI in overweight or obese subjects at high risk for cardiovascular disease after 40 weeks on-treatment.

Key Dates

Start date
Jan 31, 2017
Status verified
Oct 2021
Primary completion
Oct 13, 2020
Completion
Oct 13, 2020

Study Design

Enrollment
235 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Liraglutide 3.0 mg
    Drug: Liraglutide Active Drug Other Names: * Saxenda Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.
  • Placebo Comparator: Placebo
    Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names: * Placebo * Saline injection Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.

Primary Outcome Measure

Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI [ Time Frame: Baseline, 40 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390-

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By research site
University of Texas Southwestern Medical Center· Dallas, TX

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