Low Dose Liraglutide and Metformin vs. High Dose Liraglutide Alone in Treatment of Obesity
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 13, 2016
CompletedFirst Posted
Study publicly available on registry
September 21, 2016
CompletedSeptember 21, 2016
June 1, 2015
3 months
September 13, 2016
September 16, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Study Arms (2)
liraglutide
EXPERIMENTALliraglutide 3 mg QD for 12 weeks
metformin and liraglutide
EXPERIMENTALmetformin 1000 mg BID and liraglutide 1.2 mg QD for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- years old to menopause
- polycystic ovary syndrome (NICHD criteria)
- BMI of 30 kg/m² or higher
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Ljubljana
Ljubljana, 1000, Slovenia
Related Publications (1)
Jensterle M, Kravos NA, Goricar K, Janez A. Short-term effectiveness of low dose liraglutide in combination with metformin versus high dose liraglutide alone in treatment of obese PCOS: randomized trial. BMC Endocr Disord. 2017 Jan 31;17(1):5. doi: 10.1186/s12902-017-0155-9.
PMID: 28143456DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrej Janez, MD PhD
University Medical Centre Ljubljana
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
September 13, 2016
First Posted
September 21, 2016
Study Start
July 1, 2015
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
September 21, 2016
Record last verified: 2015-06
Data Sharing
- IPD Sharing
- Will not share