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The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes

Primary Purpose

Metabolism and Nutrition Disorder, Obesity

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
liraglutide
orlistat
placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolism and Nutrition Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body Mass Index (BMI) greater than or equal to 30.0 or lesser than or equal to 40.0 kg/m2
  • Stable body weight (less than 5% selfreported change within the last 3 months)

Exclusion Criteria:

  • Obesity induced by drug treatment
  • Use of approved drugs for weight lowering intervention (e.g. orlistat, sibutramin, rimonabant) within the last 3 months prior to entering trial
  • Type 1 or type 2 diabetes

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Lira placebo/Lira 2.4 mg/Lira 3.0 mg

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

Orlistat

Arm Description

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)

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)

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)

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)

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)

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)

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Body Weight at Week 20
Calculated as mean body weight at week 20 - baseline

Secondary Outcome Measures

Mean Change From Baseline in Body Weight at Week 104
Calculated as mean body weight at week 104 - baseline
Change From Baseline in Fasting Plasma Glucose at Week 20
Calculated as mean fasting plasma glucose at week 20 - baseline
Change From Baseline in Fasting Plasma Glucose at Week 104
Calculated as mean fasting plasma glucose at week 104 - baseline
Change From Baseline in Fasting Insulin at Week 20
Calculated as mean fasting insulin at week 20 - baseline
Change From Baseline in Fasting Insulin at Week 104
Calculated as mean fasting insulin at week 104 - baseline
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20
Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104
Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20
Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 20-baseline. High hsCRP level is associated with greater cardiovascular risk
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104
Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 104- baseline. High hsCRP level is associated with greater cardiovascular risk
Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20
Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 20-baseline. High PAI-1 is associated with greater cardiovascular risk
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
Change From Baseline in Fibrinogen at Week 20
Calculated as mean fibrinogen at week 20 - baseline. High fibrinogen is associated with greater cardiovascular risk
Change From Baseline in Fibrinogen at Week 104
Calculated as mean fibrinogen at week 104 - baseline. High fibrinogen is associated with greater cardiovascular risk
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
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
Change From Baseline in Waist Circumference at Week 20
Calculated as mean waist circumference at week 20-baseline.
Change From Baseline in Waist Circumference at Week 104
Calculated as mean waist circumference at week 104-baseline.
Change From Baseline in Blood Pressure at Week 20
Calculated as mean blood pressure at week 20-baseline.
Change From Baseline in Blood Pressure at Week 104
Calculated as mean blood pressure at week 104-baseline.

Full Information

First Posted
January 12, 2007
Last Updated
September 29, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00422058
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 10, 2007 (Actual)
Primary Completion Date
September 13, 2007 (Actual)
Study Completion Date
April 30, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism and Nutrition Disorder, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
564 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lira placebo/Lira 2.4 mg/Lira 3.0 mg
Arm Type
Placebo Comparator
Arm Description
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)
Arm Title
Lira 1.2 mg/Lira 3.0 mg
Arm Type
Experimental
Arm Description
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)
Arm Title
Lira 1.8 mg/Lira 3.0 mg
Arm Type
Experimental
Arm Description
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)
Arm Title
Lira 2.4 mg/Lira 3.0 mg
Arm Type
Experimental
Arm Description
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)
Arm Title
Liraglutide 3.0 mg
Arm Type
Experimental
Arm Description
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)
Arm Title
Orlistat
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
Injected s.c. (under the skin) once daily
Intervention Type
Drug
Intervention Name(s)
orlistat
Intervention Description
120 mg capsule. Administered thrice daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Injected s.c. (under the skin) once daily
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Body Weight at Week 20
Description
Calculated as mean body weight at week 20 - baseline
Time Frame
Week 0, week 20
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Body Weight at Week 104
Description
Calculated as mean body weight at week 104 - baseline
Time Frame
Week 0, week 104
Title
Change From Baseline in Fasting Plasma Glucose at Week 20
Description
Calculated as mean fasting plasma glucose at week 20 - baseline
Time Frame
Week 0, week 20
Title
Change From Baseline in Fasting Plasma Glucose at Week 104
Description
Calculated as mean fasting plasma glucose at week 104 - baseline
Time Frame
Week 0, week 104
Title
Change From Baseline in Fasting Insulin at Week 20
Description
Calculated as mean fasting insulin at week 20 - baseline
Time Frame
Week 0, week 20
Title
Change From Baseline in Fasting Insulin at Week 104
Description
Calculated as mean fasting insulin at week 104 - baseline
Time Frame
Week 0, week 104
Title
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20
Description
Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline
Time Frame
Week 0, week 20
Title
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104
Description
Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline
Time Frame
Week 0, week 104
Title
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20
Description
Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 20-baseline. High hsCRP level is associated with greater cardiovascular risk
Time Frame
Week 0, week 20
Title
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104
Description
Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 104- baseline. High hsCRP level is associated with greater cardiovascular risk
Time Frame
Week 0, week 104
Title
Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20
Description
Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 20-baseline. High PAI-1 is associated with greater cardiovascular risk
Time Frame
Week 0, week 20
Title
Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104
Description
Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 104-baseline. High PAI-1 is associated with greater cardiovascular risk
Time Frame
Week 0, week 104
Title
Change From Baseline in Fibrinogen at Week 20
Description
Calculated as mean fibrinogen at week 20 - baseline. High fibrinogen is associated with greater cardiovascular risk
Time Frame
Week 0, week 20
Title
Change From Baseline in Fibrinogen at Week 104
Description
Calculated as mean fibrinogen at week 104 - baseline. High fibrinogen is associated with greater cardiovascular risk
Time Frame
Week 0, week 104
Title
Change From Baseline in Adiponectin at Week 20
Description
Calculated as mean adiponectin at week 20-baseline. A low adiponectin level is associated with greater cardiovascular risk
Time Frame
Week 0, week 20
Title
Change From Baseline in Adiponectin at Week 104
Description
Calculated as mean adiponectin at week 104-baseline. A low adiponectin level is associated with greater cardiovascular risk
Time Frame
Week 0, week 104
Title
Change From Baseline in Waist Circumference at Week 20
Description
Calculated as mean waist circumference at week 20-baseline.
Time Frame
Week 0, week 20
Title
Change From Baseline in Waist Circumference at Week 104
Description
Calculated as mean waist circumference at week 104-baseline.
Time Frame
Week 0, week 104
Title
Change From Baseline in Blood Pressure at Week 20
Description
Calculated as mean blood pressure at week 20-baseline.
Time Frame
Week 0, week 20
Title
Change From Baseline in Blood Pressure at Week 104
Description
Calculated as mean blood pressure at week 104-baseline.
Time Frame
Week 0, week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 Type 1 or type 2 diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Novo Nordisk Investigational Site
City
Praha 1
ZIP/Postal Code
116 94
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Novo Nordisk Investigational Site
City
Frederiksberg C
ZIP/Postal Code
1958
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Århus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Helsinki
ZIP/Postal Code
00270
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Novo Nordisk Investigational Site
City
Almere
ZIP/Postal Code
1311RL
Country
Netherlands
Facility Name
Novo Nordisk Investigational Site
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Glasgow
ZIP/Postal Code
G322ER
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Luton
ZIP/Postal Code
LU4 0DZ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Norwich
ZIP/Postal Code
NR4 7TJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21844879
Citation
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. Erratum In: Int J Obes (Lond). 2012 Jun;36(6):890. Int J Obes (Lond). 2013 Feb;37(2):322.
Results Reference
result
PubMed Identifier
19853906
Citation
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. Erratum In: Lancet. 2010 Mar 20;375(9719):984.
Results Reference
result
PubMed Identifier
23942319
Citation
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.
Results Reference
result
PubMed Identifier
28473337
Citation
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. Erratum In: Diabetes Care. 2018 Jul;41(7):1538.
Results Reference
result
PubMed Identifier
28386912
Citation
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.
Results Reference
result
PubMed Identifier
28950422
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes

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