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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Centre Ljubljana
• Treatments: Liraglutide; Metformin

Criteria

Inclusion Criteria:

• 18 years old to menopause

• polycystic ovary syndrome (NICHD criteria)

• BMI of 30 kg/m² or higher

Exclusion Criteria:

• type 1 or type 2 diabetes mellitus

• history of carcinoma

• Cushing's syndrome or congenital (non-classic) adrenal hyperplasia

• personal or family history of MEN 2

• significant cardiovascular, kidney or hepatic disease

• the use of medications known or suspected to affect reproductive or metabolic functions

• the use of statins, within 90 days prior to study entry