Metabolism and Nutrition Disorder, Obesity
Conditions
Brief summary
This trial is conducted in Europe. The purpose of the 20-week trial is to investigate the efficacy of liraglutide to induce body weight loss and the purpose of the extension is to evaluate the long term safety and tolerability of liraglutide. Trial has the following trial periods: A 20-week randomised, double-blind, placebo-controlled, six-armed parallel-group, multi-centre, multinational trial with an open label orlistat comparator arm followed by an 84 week extension period.
Interventions
DRUGliraglutide
Injected s.c. (under the skin) once daily
DRUGorlistat
120 mg capsule. Administered thrice daily
DRUGplacebo
Injected s.c. (under the skin) once daily
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Body Mass Index (BMI) greater than or equal to 30.0 or lesser than or equal to 40.0 kg/m2 * Stable body weight (less than 5% selfreported change within the last 3 months)
Exclusion criteria
* Obesity induced by drug treatment * Use of approved drugs for weight lowering intervention (e.g. orlistat, sibutramin, rimonabant) within the last 3 months prior to entering trial * Type 1 or type 2 diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Body Weight at Week 20 | Week 0, week 20 | Calculated as mean body weight at week 20 - baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose at Week 20 | Week 0, week 20 | Calculated as mean fasting plasma glucose at week 20 - baseline |
| Change From Baseline in Fasting Plasma Glucose at Week 104 | Week 0, week 104 | Calculated as mean fasting plasma glucose at week 104 - baseline |
| Change From Baseline in Fasting Insulin at Week 20 | Week 0, week 20 | Calculated as mean fasting insulin at week 20 - baseline |
| Change From Baseline in Fasting Insulin at Week 104 | Week 0, week 104 | Calculated as mean fasting insulin at week 104 - baseline |
| Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20 | Week 0, week 20 | Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline |
| Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104 | Week 0, week 104 | Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline |
| Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20 | Week 0, week 20 | Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 20-baseline. High hsCRP level is associated with greater cardiovascular risk |
| Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104 | Week 0, week 104 | Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 104- baseline. High hsCRP level is associated with greater cardiovascular risk |
| Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20 | Week 0, week 20 | Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 20-baseline. High PAI-1 is associated with greater cardiovascular risk |
| Mean Change From Baseline in Body Weight at Week 104 | Week 0, week 104 | Calculated as mean body weight at week 104 - baseline |
| Change From Baseline in Fibrinogen at Week 20 | Week 0, week 20 | Calculated as mean fibrinogen at week 20 - baseline. High fibrinogen is associated with greater cardiovascular risk |
| Change From Baseline in Fibrinogen at Week 104 | Week 0, week 104 | Calculated as mean fibrinogen at week 104 - baseline. High fibrinogen is associated with greater cardiovascular risk |
| Change From Baseline in Adiponectin at Week 20 | Week 0, week 20 | Calculated as mean adiponectin at week 20-baseline. A low adiponectin level is associated with greater cardiovascular risk |
| Change From Baseline in Adiponectin at Week 104 | Week 0, week 104 | Calculated as mean adiponectin at week 104-baseline. A low adiponectin level is associated with greater cardiovascular risk |
| Change From Baseline in Waist Circumference at Week 20 | Week 0, week 20 | Calculated as mean waist circumference at week 20-baseline. |
| Change From Baseline in Waist Circumference at Week 104 | Week 0, week 104 | Calculated as mean waist circumference at week 104-baseline. |
| Change From Baseline in Blood Pressure at Week 20 | Week 0, week 20 | Calculated as mean blood pressure at week 20-baseline. |
| Change From Baseline in Blood Pressure at Week 104 | Week 0, week 104 | Calculated as mean blood pressure at week 104-baseline. |
| Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104 | Week 0, week 104 | Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 104-baseline. High PAI-1 is associated with greater cardiovascular risk |
Countries
Belgium, Czechia, Denmark, Finland, Netherlands, Spain, Sweden, United Kingdom
Participant flow
Recruitment details
19 sites in 8 countries: Denmark (3), Sweden (2), Finland (3), UK (3), Netherlands (1), Belgium (1), Spain (4) and Czech Republic (2)
Pre-assignment details
Between screening and randomisation, eligible subjects were included in a 2-week single-blind run-in period in which all subjects were placed on a hypocaloric diet. The dose of liraglutide and placebo was increased during the first 4 weeks after randomisation until maintenance dose was reached. Orlistat dose was fixed from randomisation.
Participants by arm
| Arm | Count |
|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) | 98 |
| Lira 1.2 mg/Lira 3.0 mg Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) | 95 |
| Lira 1.8 mg/Lira 3.0 mg Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) | 90 |
| Lira 2.4 mg/Lira 3.0 mg Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) | 93 |
| Liraglutide 3.0 mg Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104) | 93 |
| Orlistat Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104) | 95 |
| Total | 564 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Double-Blind, Week 0-20 | Adverse Event | 3 | 4 | 5 | 9 | 5 | 3 |
| Double-Blind, Week 0-20 | Lack of Efficacy | 2 | 1 | 1 | 0 | 0 | 1 |
| Double-Blind, Week 0-20 | Other | 11 | 3 | 8 | 8 | 4 | 10 |
| Double-Blind, Week 0-20 | Protocol Violation | 3 | 2 | 2 | 3 | 2 | 2 |
| Open-Label Extension, Week 20-104 | Adverse Event | 3 | 4 | 7 | 4 | 4 | 0 |
| Open-Label Extension, Week 20-104 | Lack of Efficacy | 3 | 2 | 5 | 2 | 0 | 1 |
| Open-Label Extension, Week 20-104 | Not giving consent for extension | 12 | 17 | 15 | 8 | 10 | 12 |
| Open-Label Extension, Week 20-104 | Other | 13 | 14 | 6 | 13 | 16 | 18 |
| Open-Label Extension, Week 20-104 | Protocol Violation | 1 | 2 | 3 | 1 | 5 | 3 |
Baseline characteristics
| Characteristic | Total | Orlistat | Liraglutide 3.0 mg | Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Lira 2.4 mg/Lira 3.0 mg | Lira 1.8 mg/Lira 3.0 mg | Lira 1.2 mg/Lira 3.0 mg |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 45.91 years STANDARD_DEVIATION 10.29 | 45.94 years STANDARD_DEVIATION 9.11 | 45.91 years STANDARD_DEVIATION 10.71 | 45.86 years STANDARD_DEVIATION 10.28 | 45.01 years STANDARD_DEVIATION 11.09 | 45.53 years STANDARD_DEVIATION 10.9 | 47.18 years STANDARD_DEVIATION 9.72 |
| Blood pressure Diastolic | 77.9 mmHg STANDARD_DEVIATION 8.4 | 76.9 mmHg STANDARD_DEVIATION 7.9 | 77.8 mmHg STANDARD_DEVIATION 8.3 | 76.8 mmHg STANDARD_DEVIATION 8.5 | 78.6 mmHg STANDARD_DEVIATION 8.2 | 77.9 mmHg STANDARD_DEVIATION 7.9 | 79.7 mmHg STANDARD_DEVIATION 9.1 |
| Blood pressure Systolic | 124.5 mmHg STANDARD_DEVIATION 12.7 | 122.7 mmHg STANDARD_DEVIATION 13.5 | 124.3 mmHg STANDARD_DEVIATION 11.3 | 123.6 mmHg STANDARD_DEVIATION 11.1 | 126.2 mmHg STANDARD_DEVIATION 13.9 | 123.4 mmHg STANDARD_DEVIATION 13 | 127.0 mmHg STANDARD_DEVIATION 13.1 |
| BMI | 34.8 kg/m^2 STANDARD_DEVIATION 2.7 | 34.1 kg/m^2 STANDARD_DEVIATION 2.6 | 34.8 kg/m^2 STANDARD_DEVIATION 2.8 | 34.9 kg/m^2 STANDARD_DEVIATION 2.8 | 35.0 kg/m^2 STANDARD_DEVIATION 2.8 | 35.0 kg/m^2 STANDARD_DEVIATION 2.6 | 34.8 kg/m^2 STANDARD_DEVIATION 2.6 |
| HbA1c | 5.60 percentage (%) of total haemoglobin STANDARD_DEVIATION 0.4 | 5.55 percentage (%) of total haemoglobin STANDARD_DEVIATION 0.32 | 5.57 percentage (%) of total haemoglobin STANDARD_DEVIATION 0.4 | 5.60 percentage (%) of total haemoglobin STANDARD_DEVIATION 0.38 | 5.54 percentage (%) of total haemoglobin STANDARD_DEVIATION 0.33 | 5.60 percentage (%) of total haemoglobin STANDARD_DEVIATION 0.4 | 5.58 percentage (%) of total haemoglobin STANDARD_DEVIATION 0.33 |
| Race/Ethnicity, Customized American Indian/Alaska Native | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black/African American | 6 participants | 1 participants | 1 participants | 1 participants | 1 participants | 2 participants | 0 participants |
| Race/Ethnicity, Customized Other | 2 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 555 participants | 93 participants | 92 participants | 97 participants | 91 participants | 88 participants | 94 participants |
| Sex: Female, Male Female | 429 Participants | 73 Participants | 70 Participants | 74 Participants | 71 Participants | 68 Participants | 73 Participants |
| Sex: Female, Male Male | 135 Participants | 22 Participants | 23 Participants | 24 Participants | 22 Participants | 22 Participants | 22 Participants |
| Waist circumference | 108.7 cm STANDARD_DEVIATION 9.8 | 107.6 cm STANDARD_DEVIATION 9.7 | 108.9 cm STANDARD_DEVIATION 8.3 | 108.3 cm STANDARD_DEVIATION 10 | 110.2 cm STANDARD_DEVIATION 10.7 | 108.2 cm STANDARD_DEVIATION 9.5 | 108.8 cm STANDARD_DEVIATION 10.4 |
| Weight | 97.2 kg STANDARD_DEVIATION 12.8 | 96.0 kg STANDARD_DEVIATION 11.7 | 97.6 kg STANDARD_DEVIATION 13.7 | 97.3 kg STANDARD_DEVIATION 12.3 | 98.4 kg STANDARD_DEVIATION 13 | 98.0 kg STANDARD_DEVIATION 12.5 | 96.2 kg STANDARD_DEVIATION 13.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 90 / 98 | 90 / 95 | 86 / 90 | 89 / 93 | 90 / 93 | 89 / 95 |
| serious Total, serious adverse events | 6 / 98 | 9 / 95 | 10 / 90 | 7 / 93 | 10 / 93 | 6 / 95 |
Outcome results
Primary
Mean Change From Baseline in Body Weight at Week 20
Calculated as mean body weight at week 20 - baseline
Time frame: Week 0, week 20
Population: ITT (intention to treat) analysis set using LOCF (last observation carried forward) is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Mean Change From Baseline in Body Weight at Week 20 | Change at Week 20 | -3.0 kg | Standard Deviation 3.3 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Mean Change From Baseline in Body Weight at Week 20 | Baseline | 97.3 kg | Standard Deviation 12.3 |
| Lira 1.2 mg/Lira 3.0 mg | Mean Change From Baseline in Body Weight at Week 20 | Change at Week 20 | -5.1 kg | Standard Deviation 3.5 |
| Lira 1.2 mg/Lira 3.0 mg | Mean Change From Baseline in Body Weight at Week 20 | Baseline | 96.4 kg | Standard Deviation 13.4 |
| Lira 1.8 mg/Lira 3.0 mg | Mean Change From Baseline in Body Weight at Week 20 | Change at Week 20 | -5.9 kg | Standard Deviation 5 |
| Lira 1.8 mg/Lira 3.0 mg | Mean Change From Baseline in Body Weight at Week 20 | Baseline | 98.0 kg | Standard Deviation 12.5 |
| Lira 2.4 mg/Lira 3.0 mg | Mean Change From Baseline in Body Weight at Week 20 | Baseline | 98.4 kg | Standard Deviation 13.1 |
| Lira 2.4 mg/Lira 3.0 mg | Mean Change From Baseline in Body Weight at Week 20 | Change at Week 20 | -6.6 kg | Standard Deviation 4.6 |
| Liraglutide 3.0 mg | Mean Change From Baseline in Body Weight at Week 20 | Baseline | 97.5 kg | Standard Deviation 13.8 |
| Liraglutide 3.0 mg | Mean Change From Baseline in Body Weight at Week 20 | Change at Week 20 | -7.6 kg | Standard Deviation 4.6 |
| Orlistat | Mean Change From Baseline in Body Weight at Week 20 | Baseline | 96.0 kg | Standard Deviation 11.7 |
| Orlistat | Mean Change From Baseline in Body Weight at Week 20 | Change at Week 20 | -4.4 kg | Standard Deviation 4.1 |
Secondary
Change From Baseline in Adiponectin at Week 104
Calculated as mean adiponectin at week 104-baseline. A low adiponectin level is associated with greater cardiovascular risk
Time frame: Week 0, week 104
Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Adiponectin at Week 104 | Baseline | 5.1 mcg/mL | Standard Deviation 3.8 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Adiponectin at Week 104 | Change at Week 104 | 3.5 mcg/mL | Standard Deviation 4.4 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Adiponectin at Week 104 | Baseline | 5.8 mcg/mL | Standard Deviation 3.8 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Adiponectin at Week 104 | Change at Week 104 | 3.3 mcg/mL | Standard Deviation 3.8 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Adiponectin at Week 104 | Baseline | 6.7 mcg/mL | Standard Deviation 4.6 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Adiponectin at Week 104 | Change at Week 104 | 1.3 mcg/mL | Standard Deviation 3.9 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Adiponectin at Week 104 | Baseline | 6.2 mcg/mL | Standard Deviation 4.6 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Adiponectin at Week 104 | Change at Week 104 | 3.4 mcg/mL | Standard Deviation 5.4 |
| Liraglutide 3.0 mg | Change From Baseline in Adiponectin at Week 104 | Baseline | 6.1 mcg/mL | Standard Deviation 4 |
| Liraglutide 3.0 mg | Change From Baseline in Adiponectin at Week 104 | Change at Week 104 | 3.2 mcg/mL | Standard Deviation 4.1 |
| Orlistat | Change From Baseline in Adiponectin at Week 104 | Baseline | 5.4 mcg/mL | Standard Deviation 4.7 |
| Orlistat | Change From Baseline in Adiponectin at Week 104 | Change at Week 104 | 3.1 mcg/mL | Standard Deviation 4.2 |
Secondary
Change From Baseline in Adiponectin at Week 20
Calculated as mean adiponectin at week 20-baseline. A low adiponectin level is associated with greater cardiovascular risk
Time frame: Week 0, week 20
Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Adiponectin at Week 20 | Change at Week 20 | 2.3 mcg/mL | Standard Deviation 5 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Adiponectin at Week 20 | Baseline | 5.1 mcg/mL | Standard Deviation 3.8 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Adiponectin at Week 20 | Change at Week 20 | 1.2 mcg/mL | Standard Deviation 5 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Adiponectin at Week 20 | Baseline | 5.8 mcg/mL | Standard Deviation 3.8 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Adiponectin at Week 20 | Change at Week 20 | 1.7 mcg/mL | Standard Deviation 6.9 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Adiponectin at Week 20 | Baseline | 6.7 mcg/mL | Standard Deviation 4.6 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Adiponectin at Week 20 | Baseline | 6.2 mcg/mL | Standard Deviation 4.6 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Adiponectin at Week 20 | Change at Week 20 | 1.6 mcg/mL | Standard Deviation 5.7 |
| Liraglutide 3.0 mg | Change From Baseline in Adiponectin at Week 20 | Baseline | 6.1 mcg/mL | Standard Deviation 4 |
| Liraglutide 3.0 mg | Change From Baseline in Adiponectin at Week 20 | Change at Week 20 | 2.3 mcg/mL | Standard Deviation 4.6 |
| Orlistat | Change From Baseline in Adiponectin at Week 20 | Baseline | 5.4 mcg/mL | Standard Deviation 4.7 |
| Orlistat | Change From Baseline in Adiponectin at Week 20 | Change at Week 20 | 1.7 mcg/mL | Standard Deviation 4.4 |
Secondary
Change From Baseline in Blood Pressure at Week 104
Calculated as mean blood pressure at week 104-baseline.
Time frame: Week 0, week 104
Population: ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Change at Week 104 (Systolic) | -2.0 mmHg | Standard Deviation 13.8 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Change at Week 104 (Diastolic) | 1.64 mmHg | Standard Deviation 8.47 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Baseline (Diastolic) | 76.78 mmHg | Standard Deviation 8.5 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Baseline (Systolic ) | 123.6 mmHg | Standard Deviation 11.1 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Change at Week 104 (Diastolic) | -0.98 mmHg | Standard Deviation 9.81 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Baseline (Diastolic) | 79.71 mmHg | Standard Deviation 9.12 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Baseline (Systolic ) | 127.2 mmHg | Standard Deviation 13.1 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Change at Week 104 (Systolic) | -4.0 mmHg | Standard Deviation 13.4 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Baseline (Systolic ) | 123.4 mmHg | Standard Deviation 13 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Baseline (Diastolic) | 77.91 mmHg | Standard Deviation 7.92 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Change at Week 104 (Systolic) | -3.8 mmHg | Standard Deviation 16 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Change at Week 104 (Diastolic) | -1.00 mmHg | Standard Deviation 9.37 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Change at Week 104 (Systolic) | -6.5 mmHg | Standard Deviation 12.6 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Baseline (Systolic ) | 126.3 mmHg | Standard Deviation 13.9 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Baseline (Diastolic) | 78.53 mmHg | Standard Deviation 8.23 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Change at Week 104 (Diastolic) | -1.99 mmHg | Standard Deviation 9.61 |
| Liraglutide 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Change at Week 104 (Diastolic) | -1.92 mmHg | Standard Deviation 9.41 |
| Liraglutide 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Baseline (Systolic ) | 124.3 mmHg | Standard Deviation 11.3 |
| Liraglutide 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Change at Week 104 (Systolic) | -5.6 mmHg | Standard Deviation 11.7 |
| Liraglutide 3.0 mg | Change From Baseline in Blood Pressure at Week 104 | Baseline (Diastolic) | 77.84 mmHg | Standard Deviation 8.38 |
| Orlistat | Change From Baseline in Blood Pressure at Week 104 | Change at Week 104 (Systolic) | -2.0 mmHg | Standard Deviation 11.7 |
| Orlistat | Change From Baseline in Blood Pressure at Week 104 | Baseline (Diastolic) | 76.94 mmHg | Standard Deviation 7.94 |
| Orlistat | Change From Baseline in Blood Pressure at Week 104 | Baseline (Systolic ) | 122.7 mmHg | Standard Deviation 13.5 |
| Orlistat | Change From Baseline in Blood Pressure at Week 104 | Change at Week 104 (Diastolic) | -1.11 mmHg | Standard Deviation 8.36 |
Secondary
Change From Baseline in Blood Pressure at Week 20
Calculated as mean blood pressure at week 20-baseline.
Time frame: Week 0, week 20
Population: ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Change at Week 20 (Diastolic) | -0.32 mmHg | Standard Deviation 7.52 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Change at Week 20 (Systolic) | -3.2 mmHg | Standard Deviation 13.3 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Baseline (Systolic ) | 123.6 mmHg | Standard Deviation 11.1 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Baseline (Diastolic) | 76.78 mmHg | Standard Deviation 8.5 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Baseline (Diastolic) | 79.71 mmHg | Standard Deviation 9.12 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Baseline (Systolic ) | 127.2 mmHg | Standard Deviation 13.1 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Change at Week 20 (Diastolic) | -1.53 mmHg | Standard Deviation 9.15 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Change at Week 20 (Systolic) | -6.1 mmHg | Standard Deviation 11.1 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Baseline (Systolic ) | 123.4 mmHg | Standard Deviation 13 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Change at Week 20 (Diastolic) | -1.61 mmHg | Standard Deviation 8.04 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Change at Week 20 (Systolic) | -4.8 mmHg | Standard Deviation 12.7 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Baseline (Diastolic) | 77.91 mmHg | Standard Deviation 7.92 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Change at Week 20 (Diastolic) | -1.39 mmHg | Standard Deviation 7.79 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Change at Week 20 (Systolic) | -9.1 mmHg | Standard Deviation 12.3 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Baseline (Diastolic) | 78.53 mmHg | Standard Deviation 8.23 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Baseline (Systolic ) | 126.3 mmHg | Standard Deviation 13.9 |
| Liraglutide 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Change at Week 20 (Systolic) | -6.4 mmHg | Standard Deviation 10 |
| Liraglutide 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Baseline (Systolic ) | 124.3 mmHg | Standard Deviation 11.3 |
| Liraglutide 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Baseline (Diastolic) | 77.84 mmHg | Standard Deviation 8.38 |
| Liraglutide 3.0 mg | Change From Baseline in Blood Pressure at Week 20 | Change at Week 20 (Diastolic) | -2.37 mmHg | Standard Deviation 7.71 |
| Orlistat | Change From Baseline in Blood Pressure at Week 20 | Change at Week 20 (Systolic) | -4.3 mmHg | Standard Deviation 10.9 |
| Orlistat | Change From Baseline in Blood Pressure at Week 20 | Baseline (Systolic ) | 122.7 mmHg | Standard Deviation 13.5 |
| Orlistat | Change From Baseline in Blood Pressure at Week 20 | Change at Week 20 (Diastolic) | -1.96 mmHg | Standard Deviation 7.82 |
| Orlistat | Change From Baseline in Blood Pressure at Week 20 | Baseline (Diastolic) | 76.94 mmHg | Standard Deviation 7.94 |
Secondary
Change From Baseline in Fasting Insulin at Week 104
Calculated as mean fasting insulin at week 104 - baseline
Time frame: Week 0, week 104
Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fasting Insulin at Week 104 | Baseline | 99.5 pmol/L | Standard Deviation 129.2 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fasting Insulin at Week 104 | Change at Week 104 | 0.7 pmol/L | Standard Deviation 53.6 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Fasting Insulin at Week 104 | Baseline | 82.9 pmol/L | Standard Deviation 43 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Fasting Insulin at Week 104 | Change at Week 104 | -13.5 pmol/L | Standard Deviation 39.7 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Fasting Insulin at Week 104 | Baseline | 85.7 pmol/L | Standard Deviation 49.5 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Fasting Insulin at Week 104 | Change at Week 104 | 18.6 pmol/L | Standard Deviation 102.6 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fasting Insulin at Week 104 | Baseline | 88.7 pmol/L | Standard Deviation 43.3 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fasting Insulin at Week 104 | Change at Week 104 | -2.1 pmol/L | Standard Deviation 47.3 |
| Liraglutide 3.0 mg | Change From Baseline in Fasting Insulin at Week 104 | Baseline | 89.1 pmol/L | Standard Deviation 51.9 |
| Liraglutide 3.0 mg | Change From Baseline in Fasting Insulin at Week 104 | Change at Week 104 | -19.6 pmol/L | Standard Deviation 44.3 |
| Orlistat | Change From Baseline in Fasting Insulin at Week 104 | Baseline | 85.5 pmol/L | Standard Deviation 48.3 |
| Orlistat | Change From Baseline in Fasting Insulin at Week 104 | Change at Week 104 | -15.3 pmol/L | Standard Deviation 39.8 |
Secondary
Change From Baseline in Fasting Insulin at Week 20
Calculated as mean fasting insulin at week 20 - baseline
Time frame: Week 0, week 20
Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fasting Insulin at Week 20 | Change at Week 20 | -15.0 pmol/L | Standard Deviation 34 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fasting Insulin at Week 20 | Baseline | 99.5 pmol/L | Standard Deviation 129.2 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Fasting Insulin at Week 20 | Baseline | 82.9 pmol/L | Standard Deviation 43 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Fasting Insulin at Week 20 | Change at Week 20 | 8.7 pmol/L | Standard Deviation 105.3 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Fasting Insulin at Week 20 | Baseline | 85.7 pmol/L | Standard Deviation 49.5 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Fasting Insulin at Week 20 | Change at Week 20 | -0.7 pmol/L | Standard Deviation 48.2 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fasting Insulin at Week 20 | Baseline | 88.7 pmol/L | Standard Deviation 43.3 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fasting Insulin at Week 20 | Change at Week 20 | -3.9 pmol/L | Standard Deviation 53.2 |
| Liraglutide 3.0 mg | Change From Baseline in Fasting Insulin at Week 20 | Baseline | 89.1 pmol/L | Standard Deviation 51.9 |
| Liraglutide 3.0 mg | Change From Baseline in Fasting Insulin at Week 20 | Change at Week 20 | -12.3 pmol/L | Standard Deviation 43.3 |
| Orlistat | Change From Baseline in Fasting Insulin at Week 20 | Change at Week 20 | -16.7 pmol/L | Standard Deviation 60.6 |
| Orlistat | Change From Baseline in Fasting Insulin at Week 20 | Baseline | 85.5 pmol/L | Standard Deviation 48.3 |
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 104
Calculated as mean fasting plasma glucose at week 104 - baseline
Time frame: Week 0, week 104
Population: ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 104 | Baseline | 5.42 mmol/L | Standard Deviation 0.81 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 104 | Change at Week 104 | -0.22 mmol/L | Standard Deviation 0.61 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 104 | Baseline | 5.30 mmol/L | Standard Deviation 0.61 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 104 | Change at Week 104 | -0.09 mmol/L | Standard Deviation 0.53 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 104 | Baseline | 5.29 mmol/L | Standard Deviation 0.56 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 104 | Change at Week 104 | -0.09 mmol/L | Standard Deviation 0.64 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 104 | Baseline | 5.27 mmol/L | Standard Deviation 0.57 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 104 | Change at Week 104 | -0.20 mmol/L | Standard Deviation 0.5 |
| Liraglutide 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 104 | Baseline | 5.36 mmol/L | Standard Deviation 0.61 |
| Liraglutide 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 104 | Change at Week 104 | -0.23 mmol/L | Standard Deviation 0.5 |
| Orlistat | Change From Baseline in Fasting Plasma Glucose at Week 104 | Baseline | 5.30 mmol/L | Standard Deviation 0.51 |
| Orlistat | Change From Baseline in Fasting Plasma Glucose at Week 104 | Change at Week 104 | 0.02 mmol/L | Standard Deviation 0.48 |
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 20
Calculated as mean fasting plasma glucose at week 20 - baseline
Time frame: Week 0, week 20
Population: ITT (intention to treat) analysis set using (LOCF) last observation carried forward is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 20 | Baseline | 5.42 mmol/L | Standard Deviation 0.81 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 20 | Change at Week 20 | -0.09 mmol/L | Standard Deviation 0.54 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 20 | Baseline | 5.30 mmol/L | Standard Deviation 0.61 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 20 | Change at Week 20 | -0.39 mmol/L | Standard Deviation 0.45 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 20 | Baseline | 5.29 mmol/L | Standard Deviation 0.56 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 20 | Change at Week 20 | -0.44 mmol/L | Standard Deviation 0.63 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 20 | Baseline | 5.27 mmol/L | Standard Deviation 0.57 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 20 | Change at Week 20 | -0.38 mmol/L | Standard Deviation 0.48 |
| Liraglutide 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 20 | Baseline | 5.36 mmol/L | Standard Deviation 0.61 |
| Liraglutide 3.0 mg | Change From Baseline in Fasting Plasma Glucose at Week 20 | Change at Week 20 | -0.44 mmol/L | Standard Deviation 0.44 |
| Orlistat | Change From Baseline in Fasting Plasma Glucose at Week 20 | Baseline | 5.3 mmol/L | Standard Deviation 0.51 |
| Orlistat | Change From Baseline in Fasting Plasma Glucose at Week 20 | Change at Week 20 | -0.10 mmol/L | Standard Deviation 0.41 |
Secondary
Change From Baseline in Fibrinogen at Week 104
Calculated as mean fibrinogen at week 104 - baseline. High fibrinogen is associated with greater cardiovascular risk
Time frame: Week 0, week 104
Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fibrinogen at Week 104 | Baseline | 3.60 g/L | Standard Deviation 0.67 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fibrinogen at Week 104 | Change at Week 104 | -0.10 g/L | Standard Deviation 0.74 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Fibrinogen at Week 104 | Baseline | 3.67 g/L | Standard Deviation 0.76 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Fibrinogen at Week 104 | Change at Week 104 | -0.14 g/L | Standard Deviation 0.73 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Fibrinogen at Week 104 | Baseline | 3.75 g/L | Standard Deviation 0.72 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Fibrinogen at Week 104 | Change at Week 104 | -0.15 g/L | Standard Deviation 0.98 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fibrinogen at Week 104 | Baseline | 3.64 g/L | Standard Deviation 0.72 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fibrinogen at Week 104 | Change at Week 104 | -0.24 g/L | Standard Deviation 0.74 |
| Liraglutide 3.0 mg | Change From Baseline in Fibrinogen at Week 104 | Baseline | 3.61 g/L | Standard Deviation 0.68 |
| Liraglutide 3.0 mg | Change From Baseline in Fibrinogen at Week 104 | Change at Week 104 | -0.22 g/L | Standard Deviation 0.82 |
| Orlistat | Change From Baseline in Fibrinogen at Week 104 | Baseline | 3.68 g/L | Standard Deviation 0.82 |
| Orlistat | Change From Baseline in Fibrinogen at Week 104 | Change at Week 104 | -0.39 g/L | Standard Deviation 1.24 |
Secondary
Change From Baseline in Fibrinogen at Week 20
Calculated as mean fibrinogen at week 20 - baseline. High fibrinogen is associated with greater cardiovascular risk
Time frame: Week 0, week 20
Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fibrinogen at Week 20 | Baseline | 3.60 g/L | Standard Deviation 0.67 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fibrinogen at Week 20 | Change at Week 20 | -0.06 g/L | Standard Deviation 0.58 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Fibrinogen at Week 20 | Baseline | 3.67 g/L | Standard Deviation 0.76 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Fibrinogen at Week 20 | Change at Week 20 | 0.01 g/L | Standard Deviation 0.5 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Fibrinogen at Week 20 | Baseline | 3.75 g/L | Standard Deviation 0.72 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Fibrinogen at Week 20 | Change at Week 20 | 0.02 g/L | Standard Deviation 0.61 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fibrinogen at Week 20 | Baseline | 3.64 g/L | Standard Deviation 0.72 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Fibrinogen at Week 20 | Change at Week 20 | 0.10 g/L | Standard Deviation 0.69 |
| Liraglutide 3.0 mg | Change From Baseline in Fibrinogen at Week 20 | Baseline | 3.61 g/L | Standard Deviation 0.68 |
| Liraglutide 3.0 mg | Change From Baseline in Fibrinogen at Week 20 | Change at Week 20 | 0.05 g/L | Standard Deviation 0.55 |
| Orlistat | Change From Baseline in Fibrinogen at Week 20 | Baseline | 3.68 g/L | Standard Deviation 0.82 |
| Orlistat | Change From Baseline in Fibrinogen at Week 20 | Change at Week 20 | -0.12 g/L | Standard Deviation 0.75 |
Secondary
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104
Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline
Time frame: Week 0, week 104
Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104 | Baseline | 5.60 percentage (%) of total haemoglobin | Standard Deviation 0.38 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104 | Change at Week 104 | -0.32 percentage (%) of total haemoglobin | Standard Deviation 0.32 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104 | Baseline | 5.58 percentage (%) of total haemoglobin | Standard Deviation 0.33 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104 | Change at Week 104 | -0.25 percentage (%) of total haemoglobin | Standard Deviation 0.26 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104 | Baseline | 5.60 percentage (%) of total haemoglobin | Standard Deviation 0.4 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104 | Change at Week 104 | -0.30 percentage (%) of total haemoglobin | Standard Deviation 0.22 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104 | Baseline | 5.54 percentage (%) of total haemoglobin | Standard Deviation 0.34 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104 | Change at Week 104 | -0.25 percentage (%) of total haemoglobin | Standard Deviation 0.3 |
| Liraglutide 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104 | Baseline | 5.57 percentage (%) of total haemoglobin | Standard Deviation 0.4 |
| Liraglutide 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104 | Change at Week 104 | -0.35 percentage (%) of total haemoglobin | Standard Deviation 0.32 |
| Orlistat | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104 | Baseline | 5.55 percentage (%) of total haemoglobin | Standard Deviation 0.32 |
| Orlistat | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104 | Change at Week 104 | -0.18 percentage (%) of total haemoglobin | Standard Deviation 0.37 |
Secondary
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20
Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline
Time frame: Week 0, week 20
Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20 | Baseline | 5.60 percentage (%) of total haemoglobin | Standard Deviation 0.38 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20 | Change at Week 20 | 0.01 percentage (%) of total haemoglobin | Standard Deviation 0.22 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20 | Baseline | 5.58 percentage (%) of total haemoglobin | Standard Deviation 0.33 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20 | Change at Week 20 | -0.14 percentage (%) of total haemoglobin | Standard Deviation 0.21 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20 | Baseline | 5.60 percentage (%) of total haemoglobin | Standard Deviation 0.4 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20 | Change at Week 20 | -0.21 percentage (%) of total haemoglobin | Standard Deviation 0.25 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20 | Baseline | 5.54 percentage (%) of total haemoglobin | Standard Deviation 0.34 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20 | Change at Week 20 | -0.22 percentage (%) of total haemoglobin | Standard Deviation 0.25 |
| Liraglutide 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20 | Baseline | 5.57 percentage (%) of total haemoglobin | Standard Deviation 0.4 |
| Liraglutide 3.0 mg | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20 | Change at Week 20 | -0.24 percentage (%) of total haemoglobin | Standard Deviation 0.29 |
| Orlistat | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20 | Baseline | 5.55 percentage (%) of total haemoglobin | Standard Deviation 0.32 |
| Orlistat | Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20 | Change at Week 20 | 0.00 percentage (%) of total haemoglobin | Standard Deviation 0.21 |
Secondary
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104
Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 104- baseline. High hsCRP level is associated with greater cardiovascular risk
Time frame: Week 0, week 104
Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104 | Baseline | 3.6 mg/L | Standard Deviation 4.2 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104 | Change at Week 104 | -0.5 mg/L | Standard Deviation 2.6 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104 | Baseline | 5.1 mg/L | Standard Deviation 6.1 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104 | Change at Week 104 | -1.6 mg/L | Standard Deviation 6 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104 | Baseline | 4.4 mg/L | Standard Deviation 4.5 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104 | Change at Week 104 | -0.6 mg/L | Standard Deviation 8.6 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104 | Baseline | 4.0 mg/L | Standard Deviation 4.2 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104 | Change at Week 104 | -0.9 mg/L | Standard Deviation 3.2 |
| Liraglutide 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104 | Baseline | 3.8 mg/L | Standard Deviation 7.4 |
| Liraglutide 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104 | Change at Week 104 | -2.1 mg/L | Standard Deviation 9.3 |
| Orlistat | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104 | Baseline | 4.6 mg/L | Standard Deviation 4.5 |
| Orlistat | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104 | Change at Week 104 | 2.4 mg/L | Standard Deviation 19.4 |
Secondary
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20
Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 20-baseline. High hsCRP level is associated with greater cardiovascular risk
Time frame: Week 0, week 20
Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20 | Change at Week 20 | 0.8 mg/L | Standard Deviation 4 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20 | Baseline | 3.6 mg/L | Standard Deviation 4.2 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20 | Change at Week 20 | 0.1 mg/L | Standard Deviation 8.1 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20 | Baseline | 5.1 mg/L | Standard Deviation 6.1 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20 | Baseline | 4.4 mg/L | Standard Deviation 4.5 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20 | Change at Week 20 | -0.8 mg/L | Standard Deviation 2.9 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20 | Baseline | 4.0 mg/L | Standard Deviation 4.2 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20 | Change at Week 20 | 0.5 mg/L | Standard Deviation 4.7 |
| Liraglutide 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20 | Baseline | 3.8 mg/L | Standard Deviation 7.4 |
| Liraglutide 3.0 mg | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20 | Change at Week 20 | -1.1 mg/L | Standard Deviation 7.2 |
| Orlistat | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20 | Change at Week 20 | -0.3 mg/L | Standard Deviation 4.2 |
| Orlistat | Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20 | Baseline | 4.6 mg/L | Standard Deviation 4.5 |
Secondary
Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104
Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 104-baseline. High PAI-1 is associated with greater cardiovascular risk
Time frame: Week 0, week 104
Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104 | Baseline | 21.6 U/mL | Standard Deviation 9.3 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104 | Change at Week 104 | -1.4 U/mL | Standard Deviation 7 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104 | Baseline | 19.5 U/mL | Standard Deviation 9.9 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104 | Change at Week 104 | -0.3 U/mL | Standard Deviation 9.1 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104 | Baseline | 19.7 U/mL | Standard Deviation 9.8 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104 | Change at Week 104 | -0.8 U/mL | Standard Deviation 9.8 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104 | Baseline | 17.6 U/mL | Standard Deviation 8.7 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104 | Change at Week 104 | 0.3 U/mL | Standard Deviation 9.9 |
| Liraglutide 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104 | Baseline | 19.0 U/mL | Standard Deviation 9.1 |
| Liraglutide 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104 | Change at Week 104 | 0.4 U/mL | Standard Deviation 10.9 |
| Orlistat | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104 | Baseline | 17.4 U/mL | Standard Deviation 8.2 |
| Orlistat | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104 | Change at Week 104 | 2.9 U/mL | Standard Deviation 7.4 |
Secondary
Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20
Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 20-baseline. High PAI-1 is associated with greater cardiovascular risk
Time frame: Week 0, week 20
Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20 | Change at Week 20 | -3.0 U/mL | Standard Deviation 8 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20 | Baseline | 21.6 U/mL | Standard Deviation 9.3 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20 | Change at Week 20 | -2.0 U/mL | Standard Deviation 7.8 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20 | Baseline | 19.5 U/mL | Standard Deviation 9.9 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20 | Baseline | 19.7 U/mL | Standard Deviation 9.8 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20 | Change at Week 20 | -3.5 U/mL | Standard Deviation 9.5 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20 | Baseline | 17.6 U/mL | Standard Deviation 8.7 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20 | Change at Week 20 | -2.3 U/mL | Standard Deviation 9.5 |
| Liraglutide 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20 | Baseline | 19.0 U/mL | Standard Deviation 9.1 |
| Liraglutide 3.0 mg | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20 | Change at Week 20 | -4.5 U/mL | Standard Deviation 8.5 |
| Orlistat | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20 | Change at Week 20 | -1.2 U/mL | Standard Deviation 8.8 |
| Orlistat | Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20 | Baseline | 17.4 U/mL | Standard Deviation 8.2 |
Secondary
Change From Baseline in Waist Circumference at Week 104
Calculated as mean waist circumference at week 104-baseline.
Time frame: Week 0, week 104
Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Waist Circumference at Week 104 | Baseline | 108.3 cm | Standard Deviation 10 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Waist Circumference at Week 104 | Change at Week 104 | -10.0 cm | Standard Deviation 7.2 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Waist Circumference at Week 104 | Baseline | 109.0 cm | Standard Deviation 10.3 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Waist Circumference at Week 104 | Change at Week 104 | -8.6 cm | Standard Deviation 7.5 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Waist Circumference at Week 104 | Baseline | 108.2 cm | Standard Deviation 9.5 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Waist Circumference at Week 104 | Change at Week 104 | -9.0 cm | Standard Deviation 8.7 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Waist Circumference at Week 104 | Baseline | 110.4 cm | Standard Deviation 10.6 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Waist Circumference at Week 104 | Change at Week 104 | -10.4 cm | Standard Deviation 7.8 |
| Liraglutide 3.0 mg | Change From Baseline in Waist Circumference at Week 104 | Baseline | 108.7 cm | Standard Deviation 8.3 |
| Liraglutide 3.0 mg | Change From Baseline in Waist Circumference at Week 104 | Change at Week 104 | -9.8 cm | Standard Deviation 7.5 |
| Orlistat | Change From Baseline in Waist Circumference at Week 104 | Baseline | 107.6 cm | Standard Deviation 9.7 |
| Orlistat | Change From Baseline in Waist Circumference at Week 104 | Change at Week 104 | -9.5 cm | Standard Deviation 7.3 |
Secondary
Change From Baseline in Waist Circumference at Week 20
Calculated as mean waist circumference at week 20-baseline.
Time frame: Week 0, week 20
Population: ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Waist Circumference at Week 20 | Baseline | 108.3 cm | Standard Deviation 10 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Waist Circumference at Week 20 | Change at Week 20 | -4.2 cm | Standard Deviation 4.7 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Waist Circumference at Week 20 | Baseline | 109.0 cm | Standard Deviation 10.3 |
| Lira 1.2 mg/Lira 3.0 mg | Change From Baseline in Waist Circumference at Week 20 | Change at Week 20 | -5.8 cm | Standard Deviation 6.1 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Waist Circumference at Week 20 | Baseline | 108.2 cm | Standard Deviation 9.5 |
| Lira 1.8 mg/Lira 3.0 mg | Change From Baseline in Waist Circumference at Week 20 | Change at Week 20 | -5.9 cm | Standard Deviation 5.3 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Waist Circumference at Week 20 | Baseline | 110.4 cm | Standard Deviation 10.6 |
| Lira 2.4 mg/Lira 3.0 mg | Change From Baseline in Waist Circumference at Week 20 | Change at Week 20 | -7.2 cm | Standard Deviation 5.8 |
| Liraglutide 3.0 mg | Change From Baseline in Waist Circumference at Week 20 | Baseline | 108.7 cm | Standard Deviation 8.3 |
| Liraglutide 3.0 mg | Change From Baseline in Waist Circumference at Week 20 | Change at Week 20 | -7.9 cm | Standard Deviation 5.5 |
| Orlistat | Change From Baseline in Waist Circumference at Week 20 | Baseline | 107.6 cm | Standard Deviation 9.7 |
| Orlistat | Change From Baseline in Waist Circumference at Week 20 | Change at Week 20 | -6.0 cm | Standard Deviation 5.4 |
Secondary
Mean Change From Baseline in Body Weight at Week 104
Calculated as mean body weight at week 104 - baseline
Time frame: Week 0, week 104
Population: ITT (intention to treat) analysis set using LOCF (last observation carried forward) is all randomised and exposed subjects from the double-blind period, who have been exposed to at least one dose of trial product.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Mean Change From Baseline in Body Weight at Week 104 | Baseline | 97.3 kg | Standard Deviation 12.3 |
| Lira Placebo/Lira 2.4 mg/Lira 3.0 mg | Mean Change From Baseline in Body Weight at Week 104 | Change at Week 104 | -5.4 kg | Standard Deviation 5.9 |
| Lira 1.2 mg/Lira 3.0 mg | Mean Change From Baseline in Body Weight at Week 104 | Baseline | 96.4 kg | Standard Deviation 13.4 |
| Lira 1.2 mg/Lira 3.0 mg | Mean Change From Baseline in Body Weight at Week 104 | Change at Week 104 | -4.9 kg | Standard Deviation 5.8 |
| Lira 1.8 mg/Lira 3.0 mg | Mean Change From Baseline in Body Weight at Week 104 | Baseline | 98.0 kg | Standard Deviation 12.5 |
| Lira 1.8 mg/Lira 3.0 mg | Mean Change From Baseline in Body Weight at Week 104 | Change at Week 104 | -5.6 kg | Standard Deviation 6.5 |
| Lira 2.4 mg/Lira 3.0 mg | Mean Change From Baseline in Body Weight at Week 104 | Baseline | 98.4 kg | Standard Deviation 13.1 |
| Lira 2.4 mg/Lira 3.0 mg | Mean Change From Baseline in Body Weight at Week 104 | Change at Week 104 | -6.4 kg | Standard Deviation 7.2 |
| Liraglutide 3.0 mg | Mean Change From Baseline in Body Weight at Week 104 | Baseline | 97.5 kg | Standard Deviation 13.8 |
| Liraglutide 3.0 mg | Mean Change From Baseline in Body Weight at Week 104 | Change at Week 104 | -8.2 kg | Standard Deviation 7.1 |
| Orlistat | Mean Change From Baseline in Body Weight at Week 104 | Baseline | 96.0 kg | Standard Deviation 11.7 |
| Orlistat | Mean Change From Baseline in Body Weight at Week 104 | Change at Week 104 | -3.8 kg | Standard Deviation 6.4 |