← Trials/Trial dossier/NCT00422058
The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes
Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes: A 20-week Randomised, Double-blind, Placebo-controlled, Six Armed Parallel Group, Multi-centre, Multinational Trial With an Open Label Orlistat Comparator Arm and With an 84-week Extension Period
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
19
Recruiting sites
—
Enrollment
564
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI ≥30
Primary endpoint
•Body weight, absolute change (kg)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
Endpoints (40)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
8 endpointsMean Change From Baseline in Body Weight at Week 20
Time frame:Week 0, week 20
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), kg | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline | 97.3 | — |
| Change at Week 20 | -3.0 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline | 96.4 | — |
| Change at Week 20 | -5.1 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline | 98.0 | — |
| Change at Week 20 | -5.9 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline | 98.4 | — |
| Change at Week 20 | -6.6 | — |
| Liraglutide 3.0 mgBaseline | 97.5 | — |
| Change at Week 20 | -7.6 | — |
| OrlistatBaseline | 96.0 | — |
| Change at Week 20 | -4.4 | — |
Mean Change From Baseline in Body Weight at Week 20
Time frame:Week 0, week 20
Body weight, absolute change (kg)
change from baseline, improvement
Mean Change From Baseline in Body Weight at Week 104
Time frame:Week 0, week 104
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), kg | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline | 97.3 | — |
| Change at Week 104 | -5.4 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline | 96.4 | — |
| Change at Week 104 | -4.9 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline | 98.0 | — |
| Change at Week 104 | -5.6 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline | 98.4 | — |
| Change at Week 104 | -6.4 | — |
| Liraglutide 3.0 mgBaseline | 97.5 | — |
| Change at Week 104 | -8.2 | — |
| OrlistatBaseline | 96.0 | — |
| Change at Week 104 | -3.8 | — |
Change From Baseline in Waist Circumference at Week 20
Time frame:Week 0, week 20
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Value (mean), cm | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline | 108.3 | — |
| Change at Week 20 | -4.2 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline | 109.0 | — |
| Change at Week 20 | -5.8 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline | 108.2 | — |
| Change at Week 20 | -5.9 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline | 110.4 | — |
| Change at Week 20 | -7.2 | — |
| Liraglutide 3.0 mgBaseline | 108.7 | — |
| Change at Week 20 | -7.9 | — |
| OrlistatBaseline | 107.6 | — |
| Change at Week 20 | -6.0 | — |
Change From Baseline in Waist Circumference at Week 104
Time frame:Week 0, week 104
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Value (mean), cm | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline | 108.3 | — |
| Change at Week 104 | -10.0 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline | 109.0 | — |
| Change at Week 104 | -8.6 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline | 108.2 | — |
| Change at Week 104 | -9.0 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline | 110.4 | — |
| Change at Week 104 | -10.4 | — |
| Liraglutide 3.0 mgBaseline | 108.7 | — |
| Change at Week 104 | -9.8 | — |
| OrlistatBaseline | 107.6 | — |
| Change at Week 104 | -9.5 | — |
Mean Change From Baseline in Body Weight at Week 104
Time frame:Week 0, week 104
Body weight, absolute change (kg)
change from baseline, improvement
Change From Baseline in Waist Circumference at Week 20
Time frame:Week 0, week 20
Waist circumference, change
change from baseline, improvement
Change From Baseline in Waist Circumference at Week 104
Time frame:Week 0, week 104
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
12 endpointsChange From Baseline in Fasting Plasma Glucose at Week 20
Time frame:Week 0, week 20
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline | 5.42 | — |
| Change at Week 20 | -0.09 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline | 5.30 | — |
| Change at Week 20 | -0.39 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline | 5.29 | — |
| Change at Week 20 | -0.44 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline | 5.27 | — |
| Change at Week 20 | -0.38 | — |
| Liraglutide 3.0 mgBaseline | 5.36 | — |
| Change at Week 20 | -0.44 | — |
| OrlistatBaseline | 5.3 | — |
| Change at Week 20 | -0.10 | — |
Change From Baseline in Fasting Plasma Glucose at Week 104
Time frame:Week 0, week 104
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline | 5.42 | — |
| Change at Week 104 | -0.22 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline | 5.30 | — |
| Change at Week 104 | -0.09 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline | 5.29 | — |
| Change at Week 104 | -0.09 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline | 5.27 | — |
| Change at Week 104 | -0.20 | — |
| Liraglutide 3.0 mgBaseline | 5.36 | — |
| Change at Week 104 | -0.23 | — |
| OrlistatBaseline | 5.30 | — |
| Change at Week 104 | 0.02 | — |
Change From Baseline in Fasting Insulin at Week 20
Time frame:Week 0, week 20
change from baseline, improvement
Posted result
| Group | Value (mean), pmol/L | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline | 99.5 | — |
| Change at Week 20 | -15.0 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline | 82.9 | — |
| Change at Week 20 | 8.7 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline | 85.7 | — |
| Change at Week 20 | -0.7 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline | 88.7 | — |
| Change at Week 20 | -3.9 | — |
| Liraglutide 3.0 mgBaseline | 89.1 | — |
| Change at Week 20 | -12.3 | — |
| OrlistatBaseline | 85.5 | — |
| Change at Week 20 | -16.7 | — |
Change From Baseline in Fasting Insulin at Week 104
Time frame:Week 0, week 104
change from baseline, improvement
Posted result
| Group | Value (mean), pmol/L | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline | 99.5 | — |
| Change at Week 104 | 0.7 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline | 82.9 | — |
| Change at Week 104 | -13.5 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline | 85.7 | — |
| Change at Week 104 | 18.6 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline | 88.7 | — |
| Change at Week 104 | -2.1 | — |
| Liraglutide 3.0 mgBaseline | 89.1 | — |
| Change at Week 104 | -19.6 | — |
| OrlistatBaseline | 85.5 | — |
| Change at Week 104 | -15.3 | — |
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20
Time frame:Week 0, week 20
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), percentage (%) of total haemoglobin | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline | 5.60 | — |
| Change at Week 20 | 0.01 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline | 5.58 | — |
| Change at Week 20 | -0.14 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline | 5.60 | — |
| Change at Week 20 | -0.21 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline | 5.54 | — |
| Change at Week 20 | -0.22 | — |
| Liraglutide 3.0 mgBaseline | 5.57 | — |
| Change at Week 20 | -0.24 | — |
| OrlistatBaseline | 5.55 | — |
| Change at Week 20 | 0.00 | — |
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104
Time frame:Week 0, week 104
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), percentage (%) of total haemoglobin | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline | 5.60 | — |
| Change at Week 104 | -0.32 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline | 5.58 | — |
| Change at Week 104 | -0.25 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline | 5.60 | — |
| Change at Week 104 | -0.30 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline | 5.54 | — |
| Change at Week 104 | -0.25 | — |
| Liraglutide 3.0 mgBaseline | 5.57 | — |
| Change at Week 104 | -0.35 | — |
| OrlistatBaseline | 5.55 | — |
| Change at Week 104 | -0.18 | — |
Change From Baseline in Fasting Plasma Glucose at Week 20
Time frame:Week 0, week 20
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change From Baseline in Fasting Plasma Glucose at Week 104
Time frame:Week 0, week 104
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change From Baseline in Fasting Insulin at Week 20
Time frame:Week 0, week 20
change from baseline, improvement
Change From Baseline in Fasting Insulin at Week 104
Time frame:Week 0, week 104
change from baseline, improvement
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20
Time frame:Week 0, week 20
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104
Time frame:Week 0, week 104
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Cardiometabolic biomarkers
20 endpointsChange From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20
Time frame:Week 0, week 20
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Posted result
| Group | Value (mean), mg/L | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline | 3.6 | — |
| Change at Week 20 | 0.8 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline | 5.1 | — |
| Change at Week 20 | 0.1 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline | 4.4 | — |
| Change at Week 20 | -0.8 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline | 4.0 | — |
| Change at Week 20 | 0.5 | — |
| Liraglutide 3.0 mgBaseline | 3.8 | — |
| Change at Week 20 | -1.1 | — |
| OrlistatBaseline | 4.6 | — |
| Change at Week 20 | -0.3 | — |
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104
Time frame:Week 0, week 104
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Posted result
| Group | Value (mean), mg/L | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline | 3.6 | — |
| Change at Week 104 | -0.5 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline | 5.1 | — |
| Change at Week 104 | -1.6 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline | 4.4 | — |
| Change at Week 104 | -0.6 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline | 4.0 | — |
| Change at Week 104 | -0.9 | — |
| Liraglutide 3.0 mgBaseline | 3.8 | — |
| Change at Week 104 | -2.1 | — |
| OrlistatBaseline | 4.6 | — |
| Change at Week 104 | 2.4 | — |
Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20
Time frame:Week 0, week 20
change from baseline, improvement
Posted result
| Group | Value (mean), U/mL | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline | 21.6 | — |
| Change at Week 20 | -3.0 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline | 19.5 | — |
| Change at Week 20 | -2.0 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline | 19.7 | — |
| Change at Week 20 | -3.5 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline | 17.6 | — |
| Change at Week 20 | -2.3 | — |
| Liraglutide 3.0 mgBaseline | 19.0 | — |
| Change at Week 20 | -4.5 | — |
| OrlistatBaseline | 17.4 | — |
| Change at Week 20 | -1.2 | — |
Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104
Time frame:Week 0, week 104
change from baseline, improvement
Posted result
| Group | Value (mean), U/mL | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline | 21.6 | — |
| Change at Week 104 | -1.4 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline | 19.5 | — |
| Change at Week 104 | -0.3 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline | 19.7 | — |
| Change at Week 104 | -0.8 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline | 17.6 | — |
| Change at Week 104 | 0.3 | — |
| Liraglutide 3.0 mgBaseline | 19.0 | — |
| Change at Week 104 | 0.4 | — |
| OrlistatBaseline | 17.4 | — |
| Change at Week 104 | 2.9 | — |
Change From Baseline in Fibrinogen at Week 20
Time frame:Week 0, week 20
Fibrinogen, change
change from baseline, improvement
Posted result
| Group | Value (mean), g/L | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline | 3.60 | — |
| Change at Week 20 | -0.06 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline | 3.67 | — |
| Change at Week 20 | 0.01 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline | 3.75 | — |
| Change at Week 20 | 0.02 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline | 3.64 | — |
| Change at Week 20 | 0.10 | — |
| Liraglutide 3.0 mgBaseline | 3.61 | — |
| Change at Week 20 | 0.05 | — |
| OrlistatBaseline | 3.68 | — |
| Change at Week 20 | -0.12 | — |
Change From Baseline in Fibrinogen at Week 104
Time frame:Week 0, week 104
Fibrinogen, change
change from baseline, improvement
Posted result
| Group | Value (mean), g/L | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline | 3.60 | — |
| Change at Week 104 | -0.10 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline | 3.67 | — |
| Change at Week 104 | -0.14 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline | 3.75 | — |
| Change at Week 104 | -0.15 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline | 3.64 | — |
| Change at Week 104 | -0.24 | — |
| Liraglutide 3.0 mgBaseline | 3.61 | — |
| Change at Week 104 | -0.22 | — |
| OrlistatBaseline | 3.68 | — |
| Change at Week 104 | -0.39 | — |
Change From Baseline in Adiponectin at Week 20
Time frame:Week 0, week 20
Adiponectin, change
change from baseline, improvement
Posted result
| Group | Value (mean), mcg/mL | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline | 5.1 | — |
| Change at Week 20 | 2.3 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline | 5.8 | — |
| Change at Week 20 | 1.2 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline | 6.7 | — |
| Change at Week 20 | 1.7 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline | 6.2 | — |
| Change at Week 20 | 1.6 | — |
| Liraglutide 3.0 mgBaseline | 6.1 | — |
| Change at Week 20 | 2.3 | — |
| OrlistatBaseline | 5.4 | — |
| Change at Week 20 | 1.7 | — |
Change From Baseline in Adiponectin at Week 104
Time frame:Week 0, week 104
Adiponectin, change
change from baseline, improvement
Posted result
| Group | Value (mean), mcg/mL | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline | 5.1 | — |
| Change at Week 104 | 3.5 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline | 5.8 | — |
| Change at Week 104 | 3.3 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline | 6.7 | — |
| Change at Week 104 | 1.3 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline | 6.2 | — |
| Change at Week 104 | 3.4 | — |
| Liraglutide 3.0 mgBaseline | 6.1 | — |
| Change at Week 104 | 3.2 | — |
| OrlistatBaseline | 5.4 | — |
| Change at Week 104 | 3.1 | — |
Change From Baseline in Blood Pressure at Week 20
Time frame:Week 0, week 20
change from baseline, improvement
Posted result
| Group | Value (mean), mmHg | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline (Systolic ) | 123.6 | — |
| Change at Week 20 (Systolic) | -3.2 | — |
| Baseline (Diastolic) | 76.78 | — |
| Change at Week 20 (Diastolic) | -0.32 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline (Systolic ) | 127.2 | — |
| Change at Week 20 (Systolic) | -6.1 | — |
| Baseline (Diastolic) | 79.71 | — |
| Change at Week 20 (Diastolic) | -1.53 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline (Systolic ) | 123.4 | — |
| Change at Week 20 (Systolic) | -4.8 | — |
| Baseline (Diastolic) | 77.91 | — |
| Change at Week 20 (Diastolic) | -1.61 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline (Systolic ) | 126.3 | — |
| Change at Week 20 (Systolic) | -9.1 | — |
| Baseline (Diastolic) | 78.53 | — |
| Change at Week 20 (Diastolic) | -1.39 | — |
| Liraglutide 3.0 mgBaseline (Systolic ) | 124.3 | — |
| Change at Week 20 (Systolic) | -6.4 | — |
| Baseline (Diastolic) | 77.84 | — |
| Change at Week 20 (Diastolic) | -2.37 | — |
| OrlistatBaseline (Systolic ) | 122.7 | — |
| Change at Week 20 (Systolic) | -4.3 | — |
| Baseline (Diastolic) | 76.94 | — |
| Change at Week 20 (Diastolic) | -1.96 | — |
Change From Baseline in Blood Pressure at Week 104
Time frame:Week 0, week 104
change from baseline, improvement
Posted result
| Group | Value (mean), mmHg | 95% CI |
|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mgBaseline (Systolic ) | 123.6 | — |
| Change at Week 104 (Systolic) | -2.0 | — |
| Baseline (Diastolic) | 76.78 | — |
| Change at Week 104 (Diastolic) | 1.64 | — |
| Lira 1.2 mg/Lira 3.0 mgBaseline (Systolic ) | 127.2 | — |
| Change at Week 104 (Systolic) | -4.0 | — |
| Baseline (Diastolic) | 79.71 | — |
| Change at Week 104 (Diastolic) | -0.98 | — |
| Lira 1.8 mg/Lira 3.0 mgBaseline (Systolic ) | 123.4 | — |
| Change at Week 104 (Systolic) | -3.8 | — |
| Baseline (Diastolic) | 77.91 | — |
| Change at Week 104 (Diastolic) | -1.00 | — |
| Lira 2.4 mg/Lira 3.0 mgBaseline (Systolic ) | 126.3 | — |
| Change at Week 104 (Systolic) | -6.5 | — |
| Baseline (Diastolic) | 78.53 | — |
| Change at Week 104 (Diastolic) | -1.99 | — |
| Liraglutide 3.0 mgBaseline (Systolic ) | 124.3 | — |
| Change at Week 104 (Systolic) | -5.6 | — |
| Baseline (Diastolic) | 77.84 | — |
| Change at Week 104 (Diastolic) | -1.92 | — |
| OrlistatBaseline (Systolic ) | 122.7 | — |
| Change at Week 104 (Systolic) | -2.0 | — |
| Baseline (Diastolic) | 76.94 | — |
| Change at Week 104 (Diastolic) | -1.11 | — |
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20
Time frame:Week 0, week 20
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104
Time frame:Week 0, week 104
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20
Time frame:Week 0, week 20
change from baseline, improvement
Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104
Time frame:Week 0, week 104
change from baseline, improvement
Change From Baseline in Fibrinogen at Week 20
Time frame:Week 0, week 20
Fibrinogen, change
change from baseline, improvement
Change From Baseline in Fibrinogen at Week 104
Time frame:Week 0, week 104
Fibrinogen, change
change from baseline, improvement
Change From Baseline in Adiponectin at Week 20
Time frame:Week 0, week 20
Adiponectin, change
change from baseline, improvement
Change From Baseline in Adiponectin at Week 104
Time frame:Week 0, week 104
Adiponectin, change
change from baseline, improvement
Change From Baseline in Blood Pressure at Week 20
Time frame:Week 0, week 20
change from baseline, improvement
Change From Baseline in Blood Pressure at Week 104
Time frame:Week 0, week 104
change from baseline, improvement
Publications (6)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- International journal of obesity (2005)2014 May (month)PMID23942319doi:10.1038/ijo.2013.149via CT.gov reference + pubmed nct search
- International journal of obesity (2005)2012 Jun (month)PMID21844879doi:10.1038/ijo.2011.158via CT.gov reference
- Lancet (London, England)2009 Nov 7PMID19853906doi:10.1016/S0140-6736(09)61375-1via CT.gov reference + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.