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

University Medical Centre Ljubljana

Status and phase: Completed; Phase 4

Conditions: Polycystic Ovary Syndrome; Obesity

Treatments: Drug: metformin and liraglutide; Drug: liraglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT02909933

COMBO - LIRA 3

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

liraglutide

Experimental group

Description:

liraglutide 3 mg QD for 12 weeks

Treatment:

Drug: liraglutide

metformin and liraglutide

Experimental group

Description:

metformin 1000 mg BID and liraglutide 1.2 mg QD for 12 weeks

Treatment:

Drug: metformin and liraglutide