Polycystic Ovary SyndromePhase 4LIPTNCT02073929
LIPT - Liraglutide in Polycystic Ovary Syndrome
A Phase 4 study testing Liraglutide for 26 weeks in people with Polycystic Ovary Syndrome and Cardiovascular Disease, run by Jens Faber at 3 sites in Denmark.
Trial summary
Polycystic ovary syndrome (PCOS) affects 5-10% of women in fertile age. PCOS is associated with metabolic syndrom, diabetes and and increased risk og cardiovascular disease. The study investigates the effect af intervention with GLP-1-analog on risk markers of cardiovascular disease in women with PCOS. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Cardiovascular Disease
- What is being tested?
- Liraglutide for 26 weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 3 sitesDenmark
- Study dates
- Mar 2014to Dec 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PCOS
- >18 years
- premenopausal
- BMI >25 og 25 and thereunder + insulin resistent
Who cannot join
- actualt or intended pregnancy
- inadeqvat contraception
- hormonal contraception within 6 weeks
- metfoomin, GLP-1-analog or DPP IV inhibitor within 3 months
- medications affectiv hemostatic mechanisme
- diabetes or other severe comorbidity
- familar MEN
- ...
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Dept. of Medicine and Dept. of Gyn-Obs, Herlev Hospital
Herlev, 2730
Herlev Hospital, Dept of Gynecology
Herlev, 2730
Dept. of Medicine and Dept. of Obstetrics and Gynaecology, Herlev Hospital
Herlev, DK-2730
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Study of the Effect of Liraglutide in Polycystic Ovary Syndrome on Risk Markers of Vascular Thrombosis.
Polycystic ovary syndrome (PCOS) affects 5-10% of women in fertile age. PCOS is associated with metabolic syndrom, diabetes and and increased risk og cardiovascular disease.
The study investigates the effect af intervention with GLP-1-analog on risk markers of cardiovascular disease in women with PCOS.
70 women will be included in af RCT.
Hypothesis: GLP-1-analog treatment in women with PCOS (without diabetes) will result in a beneficial reduction in risk markers of vascular thrombosis and early cardiovascular disease.
- Conditions
- Polycystic Ovary Syndrome, Cardiovascular Disease
- Being tested
- Liraglutide for 26 weeks, placebo
- Medical subject headings
- Polycystic Ovary Syndrome, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide for 26 weeksDrug
GLP-1-analogue Liraglutide s.c. 1,8mg daily for 26 weeks
placeboDrug
Placebo s.c. daily for 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Liraglutide s.c. 1,8mg daily for 26 weeks Receives: Drug: Liraglutide for 26 weeks |
| Placebo | Placebo comparator | Placebo s.c. daily for 26 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endogenous Thrombin Potential (ETP)
Area under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min
Measured: at time 0 and 26 weeks
Secondary outcomes (1)
Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1
Measured: at time 0 and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Faber
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jens Faber, Herlev Hospital
- Investigators
- Jens Faber, DSc, Principal investigator, Dept. of Medicine, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073929
- Sponsor's protocol ID
- EudraCT nr 2013-003862-15
- Acronym
- LIPT
- Status last verified
- Jun 2015
- First submitted
- 25 Feb 2014
- Last updated
- 28 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Frossing S, Nylander M, Chabanova E, Frystyk J, Holst JJ, Kistorp C, Skouby SO, Faber J. Effect of liraglutide on ectopic fat in polycystic ovary syndrome: A randomized clinical trial. Diabetes Obes Metab. 2018 Jan;20(1):215-218. doi: 10.1111/dom.13053. Epub 2017 Aug 11.
PubMed 28681988
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Study of the Effect of Liraglutide in Polycystic Ovary Syndrome on Risk Markers of Vascular Thrombosis.
- ClinicalTrials.gov ID
- NCT02073929
- Acronym / sponsor ID
- LIPT / EudraCT nr 2013-003862-15
- Conditions
- Polycystic Ovary Syndrome, Cardiovascular Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Jens FaberUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Feb 2014 (estimated)
- Results
- Posted 28 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Polycystic ovary syndrome (PCOS) affects 5-10% of women in fertile age. PCOS is associated with metabolic syndrom, diabetes and and increased risk og cardiovascular disease.
The study investigates the effect af intervention with GLP-1-analog on risk markers of cardiovascular disease in women with PCOS.
70 women will be included in af RCT.
Hypothesis: GLP-1-analog treatment in women with PCOS (without diabetes) will result in a beneficial reduction in risk markers of vascular thrombosis and early cardiovascular disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: Liraglutide for 26 weeksLiraglutide s.c. 1,8mg daily for 26 weeks |
| Placebo | Placebo comparator | Drug: placeboPlacebo s.c. daily for 26 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- PCOS
- >18 years
- premenopausal
- BMI >25 og 25 and thereunder + insulin resistent
Key exclusion criteria (8 listed)
- actualt or intended pregnancy
- inadeqvat contraception
- hormonal contraception within 6 weeks
- metfoomin, GLP-1-analog or DPP IV inhibitor within 3 months
- medications affectiv hemostatic mechanisme
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 |
|---|---|---|
| Liraglutide for 26 weeksGLP-1-analogue Liraglutide s.c. 1,8mg daily for 26 weeks | Drug | Active |
| placeboPlacebo s.c. daily for 26 weeks | Drug | Placebo |
Primary outcome
Change in Endogenous Thrombin Potential (ETP)
Time frame: at time 0 and 26 weeks
Area under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min
1 secondary outcome
Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1
Time frame: at time 0 and 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28681988Frossing S, Nylander M, Chabanova E, Frystyk J, Holst JJ, Kistorp C, Skouby SO, Faber J. Effect of liraglutide on ectopic fat in polycystic ovary syndrome: A randomized clinical trial. Diabetes Obes Metab. 2018 Jan;20(1):215-218. doi: 10.1111/dom.13053. Epub 2017 Aug 11.
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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.
Jens Faber, DSc principal investigator
Dept. of Medicine, Herlev Hospital
3 sites 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 for 26 weeks in people with Polycystic Ovary Syndrome and Cardiovascular Disease, run by Jens Faber at 3 sites in Denmark.
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 4 inclusion and 8 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 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 28 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Endogenous Thrombin Potential (ETP) (time frame: at time 0 and 26 weeks). 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 NCT02073929, 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 28 Feb 2019.