The Effect of Liraglutide on Body Weight in Obese Subject... | NCT00422058 | Trialant
NCT00422058
Sponsor
Novo Nordisk A/S
Status
Completed
Last Update Posted
Nov 1, 2017Actual
Enrollment
564Actual
Phase
Phase 2
Conditions
Metabolism and Nutrition Disorder
Obesity
Interventions
liraglutide
orlistat
placebo
Countries
Belgium
Czechia
Denmark
Finland
Netherlands
Spain
Sweden
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00422058
Obsolete or Duplicate NCT IDs
NCT00480909
Organization Study
NN8022-1807
Secondary IDs
ID
Type
Description
Link
2006-004481-13
EudraCT Number
Brief Title
The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes
Official Title
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
Acronym
Not provided
Organization
Novo Nordisk A/SINDUSTRY
Status Module
Record Verification Date
Sep 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 10, 2007Actual
Primary Completion Date
Sep 13, 2007Actual
Completion Date
Apr 30, 2009Actual
First Submitted Date
Jan 12, 2007
First Submission Date that Met QC Criteria
Jan 12, 2007
First Posted Date
Jan 15, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 27, 2010
Results First Submitted that Met QC Criteria
Oct 5, 2010
Results First Posted Date
Oct 28, 2010Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 29, 2017
Last Update Posted Date
Nov 1, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novo Nordisk A/SINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Metabolism and Nutrition Disorder
Obesity
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
564Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Lira placebo/Lira 2.4 mg/Lira 3.0 mg
Placebo Comparator
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)
Drug: placebo
Lira 1.2 mg/Lira 3.0 mg
Experimental
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)
Drug: liraglutide
Lira 1.8 mg/Lira 3.0 mg
Experimental
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)
Drug: liraglutide
Lira 2.4 mg/Lira 3.0 mg
Experimental
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)
Drug: liraglutide
Interventions
Name
Type
Description
Arm Group Labels
Other Names
liraglutide
Drug
Injected s.c. (under the skin) once daily
Lira 1.2 mg/Lira 3.0 mg
Lira 1.8 mg/Lira 3.0 mg
Lira 2.4 mg/Lira 3.0 mg
Liraglutide 3.0 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Change From Baseline in Body Weight at Week 20
Calculated as mean body weight at week 20 - baseline
Week 0, week 20
Secondary Outcomes
Measure
Description
Time Frame
Mean Change From Baseline in Body Weight at Week 104
Calculated as mean body weight at week 104 - baseline
Week 0, week 104
Change From Baseline in Fasting Plasma Glucose at Week 20
Calculated as mean fasting plasma glucose at week 20 - baseline
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Astrup A, Carraro R, Finer N, Harper A, Kunesova M, Lean ME, Niskanen L, Rasmussen MF, Rissanen A, Rossner S, Savolainen MJ, Van Gaal L; NN8022-1807 Investigators. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. Int J Obes (Lond). 2012 Jun;36(6):843-54. doi: 10.1038/ijo.2011.158. Epub 2011 Aug 16.
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.
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)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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)
FG001
Periods
Title
Milestones
Reasons Not Completed
Double-Blind, Week 0-20
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Liraglutide 3.0 mg
Experimental
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)
Drug: liraglutide
Drug: placebo
Orlistat
Active Comparator
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)
Drug: orlistat
orlistat
Drug
120 mg capsule. Administered thrice daily
Orlistat
placebo
Drug
Injected s.c. (under the skin) once daily
Lira placebo/Lira 2.4 mg/Lira 3.0 mg
Liraglutide 3.0 mg
Week 0, week 20
Change From Baseline in Fasting Plasma Glucose at Week 104
Calculated as mean fasting plasma glucose at week 104 - baseline
Week 0, week 104
Change From Baseline in Fasting Insulin at Week 20
Calculated as mean fasting insulin at week 20 - baseline
Week 0, week 20
Change From Baseline in Fasting Insulin at Week 104
Calculated as mean fasting insulin at week 104 - baseline
Week 0, week 104
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20
Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline
Week 0, week 20
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104
Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline
Week 0, week 104
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
Week 0, week 20
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
Week 0, week 104
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
Week 0, week 20
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
Week 0, week 104
Change From Baseline in Fibrinogen at Week 20
Calculated as mean fibrinogen at week 20 - baseline. High fibrinogen is associated with greater cardiovascular risk
Week 0, week 20
Change From Baseline in Fibrinogen at Week 104
Calculated as mean fibrinogen at week 104 - baseline. High fibrinogen is associated with greater cardiovascular risk
Week 0, week 104
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
Week 0, week 20
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
Week 0, week 104
Change From Baseline in Waist Circumference at Week 20
Calculated as mean waist circumference at week 20-baseline.
Week 0, week 20
Change From Baseline in Waist Circumference at Week 104
Calculated as mean waist circumference at week 104-baseline.
Week 0, week 104
Change From Baseline in Blood Pressure at Week 20
Calculated as mean blood pressure at week 20-baseline.
Week 0, week 20
Change From Baseline in Blood Pressure at Week 104
Calculated as mean blood pressure at week 104-baseline.
Week 0, week 104
Prague
116 94
Czechia
Novo Nordisk Investigational Site
Prague
128 08
Czechia
Novo Nordisk Investigational Site
Århus C
8000
Denmark
Novo Nordisk Investigational Site
Frederiksberg C
1958
Denmark
Novo Nordisk Investigational Site
Hvidovre
2650
Denmark
Novo Nordisk Investigational Site
Helsinki
00270
Finland
Novo Nordisk Investigational Site
Kuopio
70210
Finland
Novo Nordisk Investigational Site
Oulu
90220
Finland
Novo Nordisk Investigational Site
Almere Stad
1311RL
Netherlands
Novo Nordisk Investigational Site
Barcelona
08022
Spain
Novo Nordisk Investigational Site
Madrid
28006
Spain
Novo Nordisk Investigational Site
Madrid
28007
Spain
Novo Nordisk Investigational Site
Pamplona
31008
Spain
Novo Nordisk Investigational Site
Malmö
205 02
Sweden
Novo Nordisk Investigational Site
Stockholm
141 86
Sweden
Novo Nordisk Investigational Site
Glasgow
G322ER
United Kingdom
Novo Nordisk Investigational Site
Luton
LU4 0DZ
United Kingdom
Novo Nordisk Investigational Site
Norwich
NR4 7TJ
United Kingdom
Result
Astrup A, Rossner S, Van Gaal L, Rissanen A, Niskanen L, Al Hakim M, Madsen J, Rasmussen MF, Lean ME; NN8022-1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009 Nov 7;374(9701):1606-16. doi: 10.1016/S0140-6736(09)61375-1. Epub 2009 Oct 23.
Lean ME, Carraro R, Finer N, Hartvig H, Lindegaard ML, Rossner S, Van Gaal L, Astrup A; NN8022-1807 Investigators. Tolerability of nausea and vomiting and associations with weight loss in a randomized trial of liraglutide in obese, non-diabetic adults. Int J Obes (Lond). 2014 May;38(5):689-97. doi: 10.1038/ijo.2013.149. Epub 2013 Aug 14.
Steinberg WM, Rosenstock J, Wadden TA, Donsmark M, Jensen CB, DeVries JH. Impact of Liraglutide on Amylase, Lipase, and Acute Pancreatitis in Participants With Overweight/Obesity and Normoglycemia, Prediabetes, or Type 2 Diabetes: Secondary Analyses of Pooled Data From the SCALE Clinical Development Program. Diabetes Care. 2017 Jul;40(7):839-848. doi: 10.2337/dc16-2684. Epub 2017 May 4.
O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21.
Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1.
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)
FG002
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)
FG003
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)
FG004
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)
FG005
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)
FG00098 subjects
FG00195 subjects
FG00290 subjects
FG00393 subjects
FG00493 subjects
FG00595 subjects
COMPLETED
FG00079 subjects
FG00185 subjects
FG00274 subjects
FG00373 subjects
FG00482 subjects
FG00579 subjects
NOT COMPLETED
FG00019 subjects
FG00110 subjects
FG00216 subjects
FG00320 subjects
FG00411 subjects
FG00516 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0014 subjects
FG0025 subjects
FG0039 subjects
FG0045 subjects
FG0053 subjects
Protocol Violation
FG0003 subjects
FG0012 subjects
FG0022 subjects
FG0033 subjects
FG004
Lack of Efficacy
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Other
FG00011 subjects
FG0013 subjects
FG0028 subjects
FG0038 subjects
FG004
Open-Label Extension, Week 20-104
Type
Comment
Milestone Data
STARTED
FG00079 subjects
FG00185 subjects
FG00274 subjects
FG00373 subjects
FG00482 subjects
FG00579 subjects
Enrolled in Extension
FG00067 subjects
FG00168 subjects
FG00259 subjects
FG00365 subjects
FG004
COMPLETED
FG00047 subjects
FG00146 subjects
FG00238 subjects
FG00345 subjects
FG004
NOT COMPLETED
FG00032 subjects
FG00139 subjects
FG00236 subjects
FG00328 subjects
FG004
Type
Comment
Reasons
Not giving consent for extension
FG00012 subjects
FG00117 subjects
FG00215 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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)
BG001
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)
BG002
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)
BG003
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)
BG004
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)
BG005
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)
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00098
BG00195
BG00290
BG00393
BG00493
BG00595
BG006564
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00045.86± 10.28
BG00147.18± 9.72
BG00245.53± 10.9
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00074
BG00173
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
White
Title
Measurements
BG00097
BG00194
BG002
BMI
BMI = Body Mass Index
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00034.9± 2.8
BG00134.8± 2.6
BG002
Weight
Mean
Standard Deviation
kg
Title
Denominators
Categories
Title
Measurements
BG00097.3± 12.3
BG00196.2± 13.5
BG002
Waist circumference
Mean
Standard Deviation
cm
Title
Denominators
Categories
Title
Measurements
BG000108.3± 10.0
BG001108.8± 10.4
BG002
HbA1c
HbA1c = glycosylated haemoglobin A1c
Mean
Standard Deviation
percentage (%) of total haemoglobin
Title
Denominators
Categories
Title
Measurements
BG0005.60± 0.38
BG0015.58± 0.33
BG002
Blood pressure
Mean
Standard Deviation
mmHg
Title
Denominators
Categories
Systolic
Title
Measurements
BG000123.6± 11.1
BG001127.0± 13.1
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Mean Change From Baseline in Body Weight at Week 20
Calculated as mean body weight at week 20 - baseline
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.
Posted
Mean
Standard Deviation
kg
Week 0, week 20
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
OG003
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)
OG004
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)
OG005
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)
Units
Counts
Participants
OG00098
OG00194
OG00290
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG00097.3± 12.3
OG00196.4± 13.4
OG00298.0± 12.5
OG003
Secondary
Mean Change From Baseline in Body Weight at Week 104
Calculated as mean body weight at week 104 - baseline
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.
Posted
Mean
Standard Deviation
kg
Week 0, week 104
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 20
Calculated as mean fasting plasma glucose at week 20 - baseline
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
Posted
Mean
Standard Deviation
mmol/L
Week 0, week 20
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
Secondary
Change From Baseline in Fasting Plasma Glucose at Week 104
Calculated as mean fasting plasma glucose at week 104 - baseline
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
Posted
Mean
Standard Deviation
mmol/L
Week 0, week 104
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
Secondary
Change From Baseline in Fasting Insulin at Week 20
Calculated as mean fasting insulin at week 20 - baseline
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Posted
Mean
Standard Deviation
pmol/L
Week 0, week 20
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
Secondary
Change From Baseline in Fasting Insulin at Week 104
Calculated as mean fasting insulin at week 104 - baseline
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Posted
Mean
Standard Deviation
pmol/L
Week 0, week 104
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
Secondary
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20
Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Posted
Mean
Standard Deviation
percentage (%) of total haemoglobin
Week 0, week 20
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
Secondary
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104
Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Posted
Mean
Standard Deviation
percentage (%) of total haemoglobin
Week 0, week 104
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
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
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Posted
Mean
Standard Deviation
mg/L
Week 0, week 20
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
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
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Posted
Mean
Standard Deviation
mg/L
Week 0, week 104
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
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
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Posted
Mean
Standard Deviation
U/mL
Week 0, week 20
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
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
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Posted
Mean
Standard Deviation
U/mL
Week 0, week 104
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
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
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Posted
Mean
Standard Deviation
g/L
Week 0, week 20
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
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
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Posted
Mean
Standard Deviation
g/L
Week 0, week 104
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
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
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Posted
Mean
Standard Deviation
mcg/mL
Week 0, week 20
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
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
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Posted
Mean
Standard Deviation
mcg/mL
Week 0, week 104
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
Secondary
Change From Baseline in Waist Circumference at Week 20
Calculated as mean waist circumference at week 20-baseline.
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Posted
Mean
Standard Deviation
cm
Week 0, week 20
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
Secondary
Change From Baseline in Waist Circumference at Week 104
Calculated as mean waist circumference at week 104-baseline.
ITT (intention to treat) analysis set, only subjects with a valid assessment (LOCF, last observation carried forward not applied).
Posted
Mean
Standard Deviation
cm
Week 0, week 104
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
Secondary
Change From Baseline in Blood Pressure at Week 20
Calculated as mean blood pressure at week 20-baseline.
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
Posted
Mean
Standard Deviation
mmHg
Week 0, week 20
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
Secondary
Change From Baseline in Blood Pressure at Week 104
Calculated as mean blood pressure at week 104-baseline.
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
Posted
Mean
Standard Deviation
mmHg
Week 0, week 104
ID
Title
Description
OG000
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)
OG001
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)
OG002
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)
Time Frame
The adverse events were collected over 104 weeks.
Description
Safety analysis set consists of all subjects exposed to trial product(s).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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)
6
98
90
98
EG001
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)
9
95
90
95
EG002
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)
10
90
86
90
EG003
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)
7
93
89
93
EG004
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)
10
93
90
93
EG005
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)
6
95
89
95
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG0030 events0 affected93 at risk
EG0042 events2 affected93 at risk
EG0051 events1 affected95 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Hernial eventration
Gastrointestinal disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected90 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA version 10.1
Systematic Assessment
EG0001 events1 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected90 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0011 events1 affected95 at risk
EG0021 events1 affected90 at risk
EG003
Abscess limb
Infections and infestations
MedDRA version 10.1
Systematic Assessment
EG0001 events1 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Appendicitis
Infections and infestations
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Cellulitis
Infections and infestations
MedDRA version 10.1
Systematic Assessment
EG0001 events1 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0011 events1 affected95 at risk
EG0021 events1 affected90 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected90 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Anaesthetic complication
Injury, poisoning and procedural complications
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Foreign body trauma
Injury, poisoning and procedural complications
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA version 10.1
Systematic Assessment
EG0001 events1 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA version 10.1
Systematic Assessment
EG0001 events1 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Ligament calcification
Musculoskeletal and connective tissue disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected90 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected90 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Stress urinary incontinence
Renal and urinary disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA version 10.1
Systematic Assessment
EG0001 events1 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Bundle branch block left
Cardiac disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected90 at risk
EG003
Thyroglossal cyst
Congenital, familial and genetic disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Vestibular neuronitis
Ear and labyrinth disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Retinal detachment
Eye disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected90 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected90 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0021 events1 affected90 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0011 events1 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Ovarian cyst ruptured
Reproductive system and breast disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Palpitations
Cardiac disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0026 events6 affected90 at risk
EG0030 events0 affected93 at risk
EG0040 events0 affected93 at risk
EG0050 events0 affected95 at risk
Vertigo
Ear and labyrinth disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA version 10.1
Systematic Assessment
EG0005 events5 affected98 at risk
EG0015 events5 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 10.1
Systematic Assessment
EG0006 events6 affected98 at risk
EG0010 events0 affected95 at risk
EG0026 events6 affected90 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA version 10.1
Systematic Assessment
EG0006 events5 affected98 at risk
EG0019 events6 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 10.1
Systematic Assessment
EG00019 events15 affected98 at risk
EG00124 events20 affected95 at risk
EG00214 events12 affected90 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 10.1
Systematic Assessment
EG00027 events20 affected98 at risk
EG00123 events15 affected95 at risk
EG00221 events16 affected90 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0017 events6 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA version 10.1
Systematic Assessment
EG00012 events10 affected98 at risk
EG00110 events9 affected95 at risk
EG0029 events9 affected90 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0025 events5 affected90 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0026 events6 affected90 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 10.1
Systematic Assessment
EG00040 events29 affected98 at risk
EG00147 events35 affected95 at risk
EG00240 events34 affected90 at risk
EG003
Steatorrhoea
Gastrointestinal disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0029 events7 affected90 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 10.1
Systematic Assessment
EG0007 events6 affected98 at risk
EG00115 events12 affected95 at risk
EG00224 events13 affected90 at risk
EG003
Fatigue
General disorders
MedDRA version 10.1
Systematic Assessment
EG0009 events8 affected98 at risk
EG0017 events7 affected95 at risk
EG0028 events8 affected90 at risk
EG003
Oedema peripheral
General disorders
MedDRA version 10.1
Systematic Assessment
EG0007 events6 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Bronchitis
Infections and infestations
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0027 events7 affected90 at risk
EG003
Cystitis
Infections and infestations
MedDRA version 10.1
Systematic Assessment
EG0006 events6 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA version 10.1
Systematic Assessment
EG00013 events13 affected98 at risk
EG00116 events13 affected95 at risk
EG00231 events20 affected90 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA version 10.1
Systematic Assessment
EG0005 events5 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Influenza
Infections and infestations
MedDRA version 10.1
Systematic Assessment
EG00016 events10 affected98 at risk
EG00137 events24 affected95 at risk
EG00217 events11 affected90 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA version 10.1
Systematic Assessment
EG00085 events41 affected98 at risk
EG00169 events37 affected95 at risk
EG00271 events34 affected90 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA version 10.1
Systematic Assessment
EG0006 events5 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Sinusitis
Infections and infestations
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG00113 events8 affected95 at risk
EG00210 events8 affected90 at risk
EG003
Tooth infection
Infections and infestations
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA version 10.1
Systematic Assessment
EG00013 events9 affected98 at risk
EG00111 events10 affected95 at risk
EG00216 events8 affected90 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA version 10.1
Systematic Assessment
EG0008 events5 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA version 10.1
Systematic Assessment
EG0007 events5 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Blood insulin increased
Investigations
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0015 events5 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Blood TSH increased
Investigations
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0027 events5 affected90 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA version 10.1
Systematic Assessment
EG0005 events5 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 10.1
Systematic Assessment
EG00015 events14 affected98 at risk
EG00110 events9 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 10.1
Systematic Assessment
EG00015 events14 affected98 at risk
EG00110 events9 affected95 at risk
EG00220 events16 affected90 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA version 10.1
Systematic Assessment
EG0006 events6 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA version 10.1
Systematic Assessment
EG00010 events9 affected98 at risk
EG0017 events5 affected95 at risk
EG0029 events9 affected90 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 10.1
Systematic Assessment
EG00012 events12 affected98 at risk
EG0018 events7 affected95 at risk
EG0028 events6 affected90 at risk
EG003
Headache
Nervous system disorders
MedDRA version 10.1
Systematic Assessment
EG00037 events23 affected98 at risk
EG00141 events23 affected95 at risk
EG00223 events16 affected90 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 10.1
Systematic Assessment
EG0008 events8 affected98 at risk
EG0018 events7 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0015 events5 affected95 at risk
EG0020 events0 affected90 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version 10.1
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected95 at risk
EG0027 events7 affected90 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Novo Nordisk acknowledges the Investigator's right to publish the entire results of the trial. Any such scientific paper, presentation, communication or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk's Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
Point of Contact
Title
Organization
Phone
Extension
Email
Public Access to Clinical Trials
Novo Nordisk A/S
clinicaltrials@novonordisk.com
ID
Term
D009748
Nutrition Disorders
D009765
Obesity
Ancestor Terms
ID
Term
D009750
Nutritional and Metabolic Diseases
D050177
Overweight
D044343
Overnutrition
D001835
Body Weight
D012816
Signs and Symptoms
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069450
Liraglutide
D000077403
Orlistat
Ancestor Terms
ID
Term
D052216
Glucagon-Like Peptide 1
D004763
Glucagon-Like Peptides
D052336
Proglucagon
D005768
Gastrointestinal Hormones
D006728
Hormones
D006730
Hormones, Hormone Substitutes, and Hormone Antagonists
D007783
Lactones
D009930
Organic Chemicals
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0052 subjects
0 subjects
FG0051 subjects
4 subjects
FG00510 subjects
72 subjects
FG00567 subjects
47 subjects
FG00545 subjects
35 subjects
FG00534 subjects
8 subjects
FG00410 subjects
FG00512 subjects
Adverse Event
FG0003 subjects
FG0014 subjects
FG0027 subjects
FG0034 subjects
FG0044 subjects
FG0050 subjects
Protocol Violation
FG0001 subjects
FG0012 subjects
FG0023 subjects
FG0031 subjects
FG0045 subjects
FG0053 subjects
Lack of Efficacy
FG0003 subjects
FG0012 subjects
FG0025 subjects
FG0032 subjects
FG0040 subjects
FG0051 subjects
Other
FG00013 subjects
FG00114 subjects
FG0026 subjects
FG00313 subjects
FG00416 subjects
FG00518 subjects
45.01
± 11.09
BG00445.91± 10.71
BG00545.94± 9.11
BG00645.91± 10.29
68
BG00371
BG00470
BG00573
BG006429
Male
BG00024
BG00122
BG00222
BG00322
BG00423
BG00522
BG006135
88
BG00391
BG00492
BG00593
BG006555
American Indian/Alaska Native
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0061
Black/African American
Title
Measurements
BG0001
BG0010
BG0022
BG0031
BG0041
BG0051
BG0066
Other
Title
Measurements
BG0000
BG0011
BG0020
BG0031
BG0040
BG0050
BG0062
35.0
± 2.6
BG00335.0± 2.8
BG00434.8± 2.8
BG00534.1± 2.6
BG00634.8± 2.7
98.0
± 12.5
BG00398.4± 13.0
BG00497.6± 13.7
BG00596.0± 11.7
BG00697.2± 12.8
108.2
± 9.5
BG003110.2± 10.7
BG004108.9± 8.3
BG005107.6± 9.7
BG006108.7± 9.8
5.60
± 0.40
BG0035.54± 0.33
BG0045.57± 0.40
BG0055.55± 0.32
BG0065.60± 0.4
123.4
± 13.0
BG003126.2± 13.9
BG004124.3± 11.3
BG005122.7± 13.5
BG006124.5± 12.7
Diastolic
Title
Measurements
BG00076.8± 8.5
BG00179.7± 9.1
BG00277.9± 7.9
BG00378.6± 8.2
BG00477.8± 8.3
BG00576.9± 7.9
BG00677.9± 8.4
92
OG00492
OG00595
98.4
± 13.1
OG00497.5± 13.8
OG00596.0± 11.7
Change at Week 20
Title
Measurements
OG000-3.0± 3.3
OG001-5.1± 3.5
OG002-5.9± 5.0
OG003-6.6± 4.6
OG004-7.6± 4.6
OG005-4.4± 4.1
OG003
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)
OG004
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)
OG005
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)
Units
Counts
Participants
OG00098
OG00194
OG00290
OG00392
OG00492
OG00595
Title
Denominators
Categories
Baseline
Title
Measurements
OG00097.3± 12.3
OG00196.4± 13.4
OG00298.0± 12.5
OG00398.4± 13.1
OG00497.5± 13.8
OG00596.0± 11.7
Change at Week 104
Title
Measurements
OG000-5.4± 5.9
OG001-4.9± 5.8
OG002-5.6± 6.5
OG003
OG003
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)
OG004
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)
OG005
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)
Units
Counts
Participants
OG00092
OG00188
OG00284
OG00389
OG00486
OG00589
Title
Denominators
Categories
Baseline
Title
Measurements
OG0005.42± 0.81
OG0015.30± 0.61
OG0025.29± 0.56
OG0035.27± 0.57
OG0045.36± 0.61
OG0055.3± 0.51
Change at Week 20
Title
Measurements
OG000-0.09± 0.54
OG001-0.39± 0.45
OG002-0.44± 0.63
OG003
OG003
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)
OG004
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)
OG005
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)
Units
Counts
Participants
OG00092
OG00188
OG00284
OG00389
OG00486
OG00589
Title
Denominators
Categories
Baseline
Title
Measurements
OG0005.42± 0.81
OG0015.30± 0.61
OG0025.29± 0.56
OG0035.27± 0.57
OG0045.36± 0.61
OG0055.30± 0.51
Change at Week 104
Title
Measurements
OG000-0.22± 0.61
OG001-0.09± 0.53
OG002-0.09± 0.64
OG003
OG003
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)
OG004
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)
OG005
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)
Units
Counts
Participants
OG00077
OG00184
OG00273
OG00373
OG00481
OG00579
Title
Denominators
Categories
Baseline
Title
Measurements
OG00099.5± 129.2
OG00182.9± 43.0
OG00285.7± 49.5
OG00388.7± 43.3
OG00489.1± 51.9
OG00585.5± 48.3
Change at Week 20
Title
Measurements
OG000-15.0± 34.0
OG0018.7± 105.3
OG002-0.7± 48.2
OG003
OG003
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)
OG004
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)
OG005
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)
Units
Counts
Participants
OG00044
OG00142
OG00233
OG00342
OG00444
OG00539
Title
Denominators
Categories
Baseline
Title
Measurements
OG00099.5± 129.2
OG00182.9± 43.0
OG00285.7± 49.5
OG00388.7± 43.3
OG00489.1± 51.9
OG00585.5± 48.3
Change at Week 104
Title
Measurements
OG0000.7± 53.6
OG001-13.5± 39.7
OG00218.6± 102.6
OG003
OG003
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)
OG004
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)
OG005
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)
Units
Counts
Participants
OG00073
OG00184
OG00270
OG00370
OG00479
OG00578
Title
Denominators
Categories
Baseline
Title
Measurements
OG0005.60± 0.38
OG0015.58± 0.33
OG0025.60± 0.40
OG0035.54± 0.34
OG0045.57± 0.40
OG0055.55± 0.32
Change at Week 20
Title
Measurements
OG0000.01± 0.22
OG001-0.14± 0.21
OG002-0.21± 0.25
OG003
OG003
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)
OG004
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)
OG005
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)
Units
Counts
Participants
OG00046
OG00145
OG00236
OG00345
OG00447
OG00545
Title
Denominators
Categories
Baseline
Title
Measurements
OG0005.60± 0.38
OG0015.58± 0.33
OG0025.60± 0.40
OG0035.54± 0.34
OG0045.57± 0.40
OG0055.55± 0.32
Change at Week 104
Title
Measurements
OG000-0.32± 0.32
OG001-0.25± 0.26
OG002-0.30± 0.22
OG003
OG003
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)
OG004
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)
OG005
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)
Units
Counts
Participants
OG00075
OG00183
OG00274
OG00372
OG00479
OG00579
Title
Denominators
Categories
Baseline
Title
Measurements
OG0003.6± 4.2
OG0015.1± 6.1
OG0024.4± 4.5
OG0034.0± 4.2
OG0043.8± 7.4
OG0054.6± 4.5
Change at Week 20
Title
Measurements
OG0000.8± 4.0
OG0010.1± 8.1
OG002-0.8± 2.9
OG003
OG003
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)
OG004
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)
OG005
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)
Units
Counts
Participants
OG00046
OG00145
OG00238
OG00345
OG00445
OG00545
Title
Denominators
Categories
Baseline
Title
Measurements
OG0003.6± 4.2
OG0015.1± 6.1
OG0024.4± 4.5
OG0034.0± 4.2
OG0043.8± 7.4
OG0054.6± 4.5
Change at Week 104
Title
Measurements
OG000-0.5± 2.6
OG001-1.6± 6.0
OG002-0.6± 8.6
OG003
OG003
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)
OG004
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)
OG005
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)
Units
Counts
Participants
OG00068
OG00169
OG00261
OG00360
OG00472
OG00565
Title
Denominators
Categories
Baseline
Title
Measurements
OG00021.6± 9.3
OG00119.5± 9.9
OG00219.7± 9.8
OG00317.6± 8.7
OG00419.0± 9.1
OG00517.4± 8.2
Change at Week 20
Title
Measurements
OG000-3.0± 8.0
OG001-2.0± 7.8
OG002-3.5± 9.5
OG003
OG003
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)
OG004
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)
OG005
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)
Units
Counts
Participants
OG00039
OG00136
OG00229
OG00337
OG00439
OG00541
Title
Denominators
Categories
Baseline
Title
Measurements
OG00021.6± 9.3
OG00119.5± 9.9
OG00219.7± 9.8
OG00317.6± 8.7
OG00419.0± 9.1
OG00517.4± 8.2
Change at Week 104
Title
Measurements
OG000-1.4± 7.0
OG001-0.3± 9.1
OG002-0.8± 9.8
OG003
OG003
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)
OG004
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)
OG005
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)
Units
Counts
Participants
OG00068
OG00171
OG00262
OG00361
OG00473
OG00567
Title
Denominators
Categories
Baseline
Title
Measurements
OG0003.60± 0.67
OG0013.67± 0.76
OG0023.75± 0.72
OG0033.64± 0.72
OG0043.61± 0.68
OG0053.68± 0.82
Change at Week 20
Title
Measurements
OG000-0.06± 0.58
OG0010.01± 0.50
OG0020.02± 0.61
OG003
OG003
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)
OG004
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)
OG005
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)
Units
Counts
Participants
OG00039
OG00138
OG00229
OG00336
OG00439
OG00541
Title
Denominators
Categories
Baseline
Title
Measurements
OG0003.60± 0.67
OG0013.67± 0.76
OG0023.75± 0.72
OG0033.64± 0.72
OG0043.61± 0.68
OG0053.68± 0.82
Change at Week 104
Title
Measurements
OG000-0.10± 0.74
OG001-0.14± 0.73
OG002-0.15± 0.98
OG003
OG003
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)
OG004
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)
OG005
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)
Units
Counts
Participants
OG00077
OG00182
OG00272
OG00370
OG00479
OG00577
Title
Denominators
Categories
Baseline
Title
Measurements
OG0005.1± 3.8
OG0015.8± 3.8
OG0026.7± 4.6
OG0036.2± 4.6
OG0046.1± 4.0
OG0055.4± 4.7
Change at Week 20
Title
Measurements
OG0002.3± 5.0
OG0011.2± 5.0
OG0021.7± 6.9
OG003
OG003
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)
OG004
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)
OG005
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)
Units
Counts
Participants
OG00039
OG00136
OG00227
OG00339
OG00435
OG00539
Title
Denominators
Categories
Baseline
Title
Measurements
OG0005.1± 3.8
OG0015.8± 3.8
OG0026.7± 4.6
OG0036.2± 4.6
OG0046.1± 4.0
OG0055.4± 4.7
Change at Week 104
Title
Measurements
OG0003.5± 4.4
OG0013.3± 3.8
OG0021.3± 3.9
OG003
OG003
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)
OG004
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)
OG005
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)
Units
Counts
Participants
OG00090
OG00193
OG00283
OG00385
OG00485
OG00587
Title
Denominators
Categories
Baseline
Title
Measurements
OG000108.3± 10.0
OG001109.0± 10.3
OG002108.2± 9.5
OG003110.4± 10.6
OG004108.7± 8.3
OG005107.6± 9.7
Change at Week 20
Title
Measurements
OG000-4.2± 4.7
OG001-5.8± 6.1
OG002-5.9± 5.3
OG003
OG003
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)
OG004
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)
OG005
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)
Units
Counts
Participants
OG00047
OG00146
OG00238
OG00345
OG00447
OG00545
Title
Denominators
Categories
Baseline
Title
Measurements
OG000108.3± 10.0
OG001109.0± 10.3
OG002108.2± 9.5
OG003110.4± 10.6
OG004108.7± 8.3
OG005107.6± 9.7
Change at Week 104
Title
Measurements
OG000-10.0± 7.2
OG001-8.6± 7.5
OG002-9.0± 8.7
OG003
OG003
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)
OG004
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)
OG005
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)
Units
Counts
Participants
OG00094
OG00188
OG00285
OG00389
OG00489
OG00590
Title
Denominators
Categories
Baseline (Systolic )
Title
Measurements
OG000123.6± 11.1
OG001127.2± 13.1
OG002123.4± 13.0
OG003126.3± 13.9
OG004124.3± 11.3
OG005122.7± 13.5
Change at Week 20 (Systolic)
Title
Measurements
OG000-3.2± 13.3
OG001-6.1± 11.1
OG002-4.8± 12.7
OG003
Baseline (Diastolic)
Title
Measurements
OG00076.78± 8.50
OG00179.71± 9.12
OG00277.91± 7.92
OG003
Change at Week 20 (Diastolic)
Title
Measurements
OG000-0.32± 7.52
OG001-1.53± 9.15
OG002-1.61± 8.04
OG003
OG003
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)
OG004
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)
OG005
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)