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CompletedNCT02909933Updated Sep 21, 2016

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

A Phase 4 interventional study of liraglutide and metformin and liraglutide in Polycystic Ovary Syndrome and Obesity, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2016-09-21.

Sponsored by University Medical Centre Ljubljana · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Polycystic Ovary Syndrome
  • Obesity
03

In context

Polycystic Ovary Syndrome

975 studies on the registry are indexed under Polycystic Ovary Syndrome; 177 are open to participants now.

This study's enrollment of 30 is below the median of 70 across 710 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

University Medical Centre Ljubljana is the lead sponsor of 293 studies on the registry; 71 are open to participants now.

Browse University Medical Centre Ljubljana studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years old to menopause
  • polycystic ovary syndrome (NICHD criteria)
  • BMI of 30 kg/m² or higher

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    liraglutide

    liraglutide 3 mg QD for 12 weeks

    Drug: liraglutide

  • Experimental
    metformin and liraglutide

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

    Drug: metformin and liraglutide

Interventions

06

What researchers measure

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.

07

Study locations

1 site
  • University Medical Center Ljubljana
    Ljubljana, 1000, Slovenia
08

References and documents

Publications

  • 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. PubMed 28143456 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02909933
Lead sponsor
University Medical Centre Ljubljana
Responsible party
Andrej Janez (MD PhD, University Medical Centre Ljubljana) — Principal investigator
First posted
Sep 21, 2016
Start date
Jul 2015
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Sep 21, 2016

Study contacts

Andrej Janez, MD PhD
principal investigator · University Medical Centre Ljubljana

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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