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

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909933
• Other study ID #: COMBO - LIRA 3
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2016
• Last updated: September 16, 2016
• Start date: July 2015
• Est. completion date: October 2015

Study information

• Verified date: June 2015
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Polycystic Ovary Syndrome

Intervention

Drug:
• liraglutide

• metformin and liraglutide

Locations

Country	Name	City	State
Slovenia	University Medical Center Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No