Polycystic Ovary SyndromePhase 4NCT02909933
Low Dose Liraglutide and Metformin vs. High Dose Liraglutide Alone in Treatment of Obesity
A Phase 4 study testing liraglutide and metformin and liraglutide in people with Polycystic Ovary Syndrome and Obesity, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Obesity
- What is being tested?
- liraglutide and metformin and liraglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- Jul 2015to Oct 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 years old to menopause
- polycystic ovary syndrome (NICHD criteria)
- BMI of 30 kg/m² or higher
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Polycystic Ovary Syndrome, Obesity
- Being tested
- liraglutide, metformin and liraglutide
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
Also called Victoza
metformin and liraglutideDrug
Also called Glucophage and Victoza
| Study group | Role | What they receive |
|---|---|---|
| liraglutide | Experimental | liraglutide 3 mg QD for 12 weeks Receives: Drug: liraglutide |
| metformin and liraglutide | Experimental | metformin 1000 mg BID and liraglutide 1.2 mg QD for 12 weeks Receives: Drug: metformin and liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome was change in body weight.
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrej Janez, University Medical Centre Ljubljana
- Investigators
- Andrej Janez, MD PhD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909933
- Sponsor's protocol ID
- COMBO - LIRA 3
- Status last verified
- Jun 2015
- First submitted
- 13 Sep 2016
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Liraglutide and Metformin vs. High Dose Liraglutide Alone in Treatment of Obesity
- ClinicalTrials.gov ID
- NCT02909933
- Acronym / sponsor ID
- COMBO - LIRA 3
- Conditions
- Polycystic Ovary Syndrome, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liraglutide | Experimental | Drug: liraglutideliraglutide 3 mg QD for 12 weeks |
| metformin and liraglutide | Experimental | Drug: metformin and liraglutidemetformin 1000 mg BID and liraglutide 1.2 mg QD for 12 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 years old to menopause
- polycystic ovary syndrome (NICHD criteria)
- BMI of 30 kg/m² or higher
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liraglutideAlso: Victoza | Drug | liraglutide |
| metformin and liraglutideAlso: Glucophage and Victoza | Drug | metformin and liraglutide |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- Derived from this study: PubMed 28143456Jensterle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrej Janez, MD PhD principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing liraglutide and metformin and liraglutide in people with Polycystic Ovary Syndrome and Obesity, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02909933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2016.