The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes

Sponsor
Novo Nordisk A/S
Study ID
NCT00422058
Phase
PHASE2
Status
Completed

Conditions

  • Metabolism and Nutrition Disorder
  • Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    Injected s.c. (under the skin) once daily
  • orlistat — DRUG
    120 mg capsule. Administered thrice daily
  • placebo — DRUG
    Injected s.c. (under the skin) once daily

Study Details

This trial is conducted in Europe. The purpose of the 20-week trial is to investigate the efficacy of liraglutide to induce body weight loss and the purpose of the extension is to evaluate the long term safety and tolerability of liraglutide. Trial has the following trial periods: A 20-week randomised, double-blind, placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open label orlistat comparator arm followed by an 84 week extension period.

Key Dates

Start date
Jan 10, 2007
Status verified
Sep 2017
Primary completion
Sep 13, 2007
Completion
Apr 30, 2009

Study Design

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

Arms

  • Placebo Comparator: Lira placebo/Lira 2.4 mg/Lira 3.0 mg
    Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
  • Experimental: Lira 1.2 mg/Lira 3.0 mg
    Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
  • Experimental: Lira 1.8 mg/Lira 3.0 mg
    Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
  • Experimental: Lira 2.4 mg/Lira 3.0 mg
    Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
  • Experimental: Liraglutide 3.0 mg
    Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
  • Active Comparator: Orlistat
    Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)

Primary Outcome Measure

Mean Change From Baseline in Body Weight at Week 20 [ Time Frame: Week 0, week 20 ]

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