Trial Outcomes & Findings for LIPT - Liraglutide in Polycystic Ovary Syndrome (NCT NCT02073929)
NCT ID: NCT02073929
Last Updated: 2019-02-28
Results Overview
Area under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
72 participants
Primary outcome timeframe
at time 0 and 26 weeks
Results posted on
2019-02-28
Participant Flow
Participant milestones
| Measure |
Liraglutide
Liraglutide s.c. 1,8mg daily for 26 weeks
Liraglutide: GLP-1-analogue Liraglutide
|
Placebo
Placebo s.c. 1,8mg daily for 26 weeks
placebo
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
24
|
|
Overall Study
COMPLETED
|
44
|
21
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Liraglutide
Liraglutide s.c. 1,8mg daily for 26 weeks
Liraglutide: GLP-1-analogue Liraglutide
|
Placebo
Placebo s.c. 1,8mg daily for 26 weeks
placebo
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
LIPT - Liraglutide in Polycystic Ovary Syndrome
Baseline characteristics by cohort
| Measure |
Liraglutide
n=48 Participants
Liraglutide
|
Placebo
n=24 Participants
Placebo
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.4 years
n=5 Participants
|
26.2 years
n=7 Participants
|
29.9 years
n=5 Participants
|
|
Sex/Gender, Customized
women
|
48 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
caucasians
|
45 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
other ethnicity
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
BMI
|
33.3 kg/m2
STANDARD_DEVIATION 5.1 • n=5 Participants
|
33.3 kg/m2
STANDARD_DEVIATION 4.6 • n=7 Participants
|
33.3 kg/m2
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Waist Circumference
|
102.6 cm
STANDARD_DEVIATION 10.8 • n=5 Participants
|
102.6 cm
STANDARD_DEVIATION 11.1 • n=7 Participants
|
102.6 cm
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Total testosterone
|
1.23 nmol/l
n=5 Participants
|
1.35 nmol/l
n=7 Participants
|
1.30 nmol/l
n=5 Participants
|
|
Endogenous Thrombin Potential
|
1796 micromol/l x min
STANDARD_DEVIATION 332 • n=5 Participants
|
1830 micromol/l x min
STANDARD_DEVIATION 285 • n=7 Participants
|
1801 micromol/l x min
STANDARD_DEVIATION 324 • n=5 Participants
|
PRIMARY outcome
Timeframe: at time 0 and 26 weeksArea under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min
Outcome measures
| Measure |
Liraglutide
n=48 Participants
Liraglutide s.c. 1,8mg daily for 26 weeks
Liraglutide: GLP-1-analogue Liraglutide
|
Placebo
n=24 Participants
Placebo s.c. 1,8mg daily for 26 weeks
placebo
|
|---|---|---|
|
Change in Endogenous Thrombin Potential (ETP)
|
-56.7 nMolar x minutes
Interval -132.3 to 17.2
|
-8.2 nMolar x minutes
Interval -98.7 to 82.3
|
SECONDARY outcome
Timeframe: at time 0 and 26 weeksOutcome measures
| Measure |
Liraglutide
n=48 Participants
Liraglutide s.c. 1,8mg daily for 26 weeks
Liraglutide: GLP-1-analogue Liraglutide
|
Placebo
n=24 Participants
Placebo s.c. 1,8mg daily for 26 weeks
placebo
|
|---|---|---|
|
Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1
|
-12 percent change in plasma PAI-1
Interval -23.0 to 0.0
|
4 percent change in plasma PAI-1
Interval -14.0 to 26.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at time 0 and 26 weeksmeasured in nmol/l
Outcome measures
| Measure |
Liraglutide
n=48 Participants
Liraglutide s.c. 1,8mg daily for 26 weeks
Liraglutide: GLP-1-analogue Liraglutide
|
Placebo
n=24 Participants
Placebo s.c. 1,8mg daily for 26 weeks
placebo
|
|---|---|---|
|
Change in Plasma Level of Adrenomedullin
|
-0.02 nmol/l
Interval -0.04 to 0.002
|
0.003 nmol/l
Interval -0.02 to 0.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at time 0 and 26 weeksmeasured in pmol/l
Outcome measures
| Measure |
Liraglutide
n=48 Participants
Liraglutide s.c. 1,8mg daily for 26 weeks
Liraglutide: GLP-1-analogue Liraglutide
|
Placebo
n=24 Participants
Placebo s.c. 1,8mg daily for 26 weeks
placebo
|
|---|---|---|
|
Change in Plasma Level of Atrial Natriuretic Peptide (ANP)
|
-11.5 pmol/l
Interval -17.0 to -6.1
|
1.4 pmol/l
Interval -7.5 to 10.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at time 0 and 26 weeksPopulation: measured as pmol/l
Outcome measures
| Measure |
Liraglutide
n=48 Participants
Liraglutide s.c. 1,8mg daily for 26 weeks
Liraglutide: GLP-1-analogue Liraglutide
|
Placebo
n=24 Participants
Placebo s.c. 1,8mg daily for 26 weeks
placebo
|
|---|---|---|
|
Change in Plasma Level of Copeptin
|
0.48 pmol/l
Interval -0.39 to 1.34
|
0.28 pmol/l
Interval -0.51 to 1.08
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at time 0 and 26 weekspercent change from baseline
Outcome measures
| Measure |
Liraglutide
n=48 Participants
Liraglutide s.c. 1,8mg daily for 26 weeks
Liraglutide: GLP-1-analogue Liraglutide
|
Placebo
n=24 Participants
Placebo s.c. 1,8mg daily for 26 weeks
placebo
|
|---|---|---|
|
Percent Change in Plasma Level of High Sensitivity C-reactive Protein (CRP)
|
-15 percent change in CRP levels
Interval -30.0 to 3.0
|
-25 percent change in CRP levels
Interval -57.0 to 30.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at time 0 and 26 weeksRation between number of bleedings during 3 months before trial and last 3 months of trial
Outcome measures
| Measure |
Liraglutide
n=48 Participants
Liraglutide s.c. 1,8mg daily for 26 weeks
Liraglutide: GLP-1-analogue Liraglutide
|
Placebo
n=24 Participants
Placebo s.c. 1,8mg daily for 26 weeks
placebo
|
|---|---|---|
|
Change in Bleeding Pattern (Bleeding Ratio)
|
0.28 n of bleedings/n of expected bleedings
Interval 0.2 to 0.36
|
0.14 n of bleedings/n of expected bleedings
Interval 0.02 to 0.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at time 0 and 26 weeksPopulation: only participants with measurable i.e. \>5% liver fat at baseline was included in this analysis
percent liver fat content
Outcome measures
| Measure |
Liraglutide
n=37 Participants
Liraglutide s.c. 1,8mg daily for 26 weeks
Liraglutide: GLP-1-analogue Liraglutide
|
Placebo
n=20 Participants
Placebo s.c. 1,8mg daily for 26 weeks
placebo
|
|---|---|---|
|
Change in Percent Liver Fat Content
|
-1.6 percentage of liver fat
Standard Deviation 0.4
|
-0.2 percentage of liver fat
Standard Deviation 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at time 0 and 26 weeksPopulation: not measured on all subjects (missing. 4 in Liraglutide and one in placebo Group)
cubic cm
Outcome measures
| Measure |
Liraglutide
n=44 Participants
Liraglutide s.c. 1,8mg daily for 26 weeks
Liraglutide: GLP-1-analogue Liraglutide
|
Placebo
n=23 Participants
Placebo s.c. 1,8mg daily for 26 weeks
placebo
|
|---|---|---|
|
Change in Body Composition (VAT)
|
-17 cubic cm
Standard Deviation 4
|
5 cubic cm
Standard Deviation 7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at time 0 and 26 weeksPopulation: not measured in all participants, one is missing in each group
measured as ml
Outcome measures
| Measure |
Liraglutide
n=47 Participants
Liraglutide s.c. 1,8mg daily for 26 weeks
Liraglutide: GLP-1-analogue Liraglutide
|
Placebo
n=23 Participants
Placebo s.c. 1,8mg daily for 26 weeks
placebo
|
|---|---|---|
|
Change in Ovarian Volume Between Baseline and Follow up (26 Weeks)
|
-2 ml
Interval -3.0 to -1.0
|
0 ml
Interval -2.0 to 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at time 0 and 26 weeksPopulation: missing one participant in placebo group
measured as pmol/l
Outcome measures
| Measure |
Liraglutide
n=48 Participants
Liraglutide s.c. 1,8mg daily for 26 weeks
Liraglutide: GLP-1-analogue Liraglutide
|
Placebo
n=23 Participants
Placebo s.c. 1,8mg daily for 26 weeks
placebo
|
|---|---|---|
|
Change in Serum Levels of Anti-Müllerian Hormone
|
-8.7 pmol/ml
Interval -17.4 to 0.6
|
3.5 pmol/ml
Interval -13.9 to 21.0
|
Adverse Events
Active
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active
n=48 participants at risk
Liraglutide s.c. 1,8mg daily for 26 weeks
Liraglutide: GLP-1-analogue Liraglutide
|
Placebo
n=24 participants at risk
Placebo s.c. 1,8mg daily for 26 weeks
placebo
|
|---|---|---|
|
Hepatobiliary disorders
gallbladder stone attack
|
4.2%
2/48 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
Other adverse events
| Measure |
Active
n=48 participants at risk
Liraglutide s.c. 1,8mg daily for 26 weeks
Liraglutide: GLP-1-analogue Liraglutide
|
Placebo
n=24 participants at risk
Placebo s.c. 1,8mg daily for 26 weeks
placebo
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
77.1%
37/48
|
12.5%
3/24
|
|
Gastrointestinal disorders
constipation
|
25.0%
12/48
|
0.00%
0/24
|
|
Gastrointestinal disorders
vomiting
|
10.4%
5/48
|
0.00%
0/24
|
|
Gastrointestinal disorders
diarrhea
|
10.4%
5/48
|
4.2%
1/24
|
|
General disorders
hypotension
|
2.1%
1/48
|
0.00%
0/24
|
Additional Information
Professor Jens Faber
Center of Endocrinology and Metabolism, Dept. of Internal Medicine, Herlev Gentofte Hospital, Denmark
Phone: +4538689016
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place