Low Dose Liraglutide and Metformin vs. High Dose Liraglutide Alone in Treatment of Obesity

Sponsor
University Medical Centre Ljubljana
Study ID
NCT02909933
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Weight reduction is the most important treatment target when polycystic ovary syndrome (PCOS) is linked to obesity. Liraglutide (LIRA) in dose of 3 mg was recently approved as an anti-obesity drug. Metformin could enhance weight lowering potential of liraglutide. We investigates short term interventions with low dose liraglutide in combination with metformin and high dose liraglutide alone influence on significant weight reduction in obese women with PCOS.

Key Dates

Start date
Jul 31, 2015
Status verified
Jun 2015
Primary completion
Oct 31, 2015
Completion
Oct 31, 2015

Study Design

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

Arms

  • Experimental: liraglutide
    liraglutide 3 mg QD for 12 weeks
  • Experimental: metformin and liraglutide
    metformin 1000 mg BID and liraglutide 1.2 mg QD for 12 weeks

Primary Outcome Measure

The main outcome was change in body weight. [ Time Frame: Patient's body weight was measured at the base point and after 12 weeks of clinical trial. ]

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