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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Polycystic Ovary Syndrome Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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liraglutide

liraglutide 3 mg QD for 12 weeks

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

metformin and liraglutide

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

Group Type EXPERIMENTAL

metformin and liraglutide

Intervention Type DRUG

Interventions

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liraglutide

Intervention Type DRUG

metformin and liraglutide

Intervention Type DRUG

Other Intervention Names

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Victoza Glucophage and Victoza

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No