Primary outcomeMean· at time 0 and 26 weeks
Change in Endogenous Thrombin Potential (ETP)
| Group | Value (nMolar x minutes) |
|---|---|
| Liraglutide | -56.7 |
| Placebo | -8.2 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataLIPT - Liraglutide in Polycystic Ovary Syndrome
Short name LIPT
NCTNCT02073929 (opens ClinicalTrials.gov in a new tab)Other idEudraCT nr 2013-003862-15
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 72 participants (actual)
- Sponsor
- Jens Faber · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
Denmark
- Start
- Mar 2014
- Primary completion
- Dec 2015
- Completion
- Dec 2015
- First posted
- 28 Feb 2014 (estimated)
- Last update posted
- 28 Feb 2019
- Conditions
- Polycystic Ovary Syndrome · Cardiovascular Disease
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201420152016
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Liraglutide for 26 weeksDrug
- placeboDrug
Arms2
Active comparator
Active
Liraglutide s.c. 1,8mg daily for 26 weeks
Placebo comparator
Placebo
Placebo s.c. daily for 26 weeks
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in Endogenous Thrombin Potential (ETP)
Time frame · at time 0 and 26 weeks
Registry description
Area under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min
Secondary outcomes(1)
Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1
Time frame · at time 0 and 26 weeks
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· at time 0 and 26 weeks
Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1
| Group | Value (percent change in plasma PAI-1) |
|---|---|
| Liraglutide | -12 |
| Placebo | 4 |
Other pre specified outcomeMedian· at time 0 and 26 weeks
Change in Plasma Level of Adrenomedullin
| Group | Value (nmol/l) |
|---|---|
| Liraglutide | -0.02 |
| Placebo | 0.003 |
Other pre specified outcomeMedian· at time 0 and 26 weeks
Change in Plasma Level of Atrial Natriuretic Peptide (ANP)
| Group | Value (pmol/l) |
|---|---|
| Liraglutide | -11.5 |
| Placebo | 1.4 |
Other pre specified outcomeMedian· at time 0 and 26 weeks
Change in Plasma Level of Copeptin
| Group | Value (pmol/l) |
|---|---|
| Liraglutide | 0.48 |
| Placebo | 0.28 |
Other pre specified outcomeMean· at time 0 and 26 weeks
Percent Change in Plasma Level of High Sensitivity C-reactive Protein (CRP)
| Group | Value (percent change in CRP levels) |
|---|---|
| Liraglutide | -15 |
| Placebo | -25 |
Other pre specified outcomeMedian· at time 0 and 26 weeks
Change in Bleeding Pattern (Bleeding Ratio)
| Group | Value (n of bleedings/n of expected bleedings) |
|---|---|
| Liraglutide | 0.28 |
| Placebo | 0.14 |
Other pre specified outcomeMean· at time 0 and 26 weeks
Change in Percent Liver Fat Content
| Group | Value (percentage of liver fat) | Spread |
|---|---|---|
| Liraglutide | -1.6 | 0.4 |
| Placebo | -0.2 | 0.7 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| ActiveLiraglutide s.c. 1,8mg daily for 26 weeks Liraglutide: GLP-1-analogue Liraglutide | – | 2 / 48 | 37 / 48 |
| PlaceboPlacebo s.c. 1,8mg daily for 26 weeks placebo | – | 1 / 24 | 3 / 24 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2018
12 results
Effect of liraglutide on ectopic fat in polycystic ovary syndrome: A randomized clinical trial.
Frøssing et al. 2018Diabetes, obesity & metabolismcited by 137
PMID 28681988DOI 10.1111/dom.13053PUB-28681988
Full text at the publisher12 results
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 60 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* PCOS
* \>18 years
* premenopausal
* BMI \>25 og 25 and thereunder + insulin resistent
Exclusion Criteria (including):
* 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
* ...
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