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

Phase 4

Completed

• Conditions: Polycystic Ovary Syndrome; Obesity
• Interventions: Drug: liraglutide; Drug: metformin and liraglutide

• Registration Number: NCT02909933
• Lead Sponsor: University Medical Centre Ljubljana

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-06
• Study Start: 2015-07
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-09-16
• Last Update Submitted: 2016-09-16
• Study First Posted: 2016-09-21
• Last Update Posted: 2016-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
liraglutide	liraglutide	liraglutide 3 mg QD for 12 weeks
metformin and liraglutide	metformin and liraglutide	metformin 1000 mg BID and liraglutide 1.2 mg QD for 12 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The secondary outcome was change in body mass index (BMI)	Patient's body weight were measured at the base point and after 12 weeks of clinical trial. Patient's height was measured at the base point.

Trial Locations

Locations (1)

University Medical Center Ljubljana; 🇸🇮 Ljubljana, Slovenia