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OpenTrials
Completed

NCT Number: NCT02909933

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

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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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Body Weight Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

Other names: Victoza

metformin and liraglutide

Drug

Other names: Glucophage and Victoza

Primary outcomes

  1. The main outcome was change in body weight.

    Time frame: Patient's body weight was measured at the base point and after 12 weeks of clinical trial.

Secondary outcomes

  1. The secondary outcome was change in body mass index (BMI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 21, 2016
Registry last updated
Sep 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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