We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00422058
First Posted: January 15, 2007
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose

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.


Condition Intervention Phase
Metabolism and Nutrition Disorder Obesity Drug: liraglutide Drug: orlistat Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Mean Change From Baseline in Body Weight at Week 20 [ Time Frame: Week 0, week 20 ]
    Calculated as mean body weight at week 20 - baseline


Secondary Outcome Measures:
  • Mean Change From Baseline in Body Weight at Week 104 [ Time Frame: Week 0, week 104 ]
    Calculated as mean body weight at week 104 - baseline

  • Change From Baseline in Fasting Plasma Glucose at Week 20 [ Time Frame: Week 0, week 20 ]
    Calculated as mean fasting plasma glucose at week 20 - baseline

  • Change From Baseline in Fasting Plasma Glucose at Week 104 [ Time Frame: Week 0, week 104 ]
    Calculated as mean fasting plasma glucose at week 104 - baseline

  • Change From Baseline in Fasting Insulin at Week 20 [ Time Frame: Week 0, week 20 ]
    Calculated as mean fasting insulin at week 20 - baseline

  • Change From Baseline in Fasting Insulin at Week 104 [ Time Frame: Week 0, week 104 ]
    Calculated as mean fasting insulin at week 104 - baseline

  • Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20 [ Time Frame: Week 0, week 20 ]
    Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline

  • Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104 [ Time Frame: Week 0, week 104 ]
    Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline

  • Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20 [ Time Frame: Week 0, week 20 ]
    Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 20-baseline. High hsCRP level is associated with greater cardiovascular risk

  • Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104 [ Time Frame: Week 0, week 104 ]
    Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 104- baseline. High hsCRP level is associated with greater cardiovascular risk

  • Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20 [ Time Frame: Week 0, week 20 ]
    Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 20-baseline. High PAI-1 is associated with greater cardiovascular risk

  • Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104 [ Time Frame: Week 0, week 104 ]
    Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 104-baseline. High PAI-1 is associated with greater cardiovascular risk

  • Change From Baseline in Fibrinogen at Week 20 [ Time Frame: Week 0, week 20 ]
    Calculated as mean fibrinogen at week 20 - baseline. High fibrinogen is associated with greater cardiovascular risk

  • Change From Baseline in Fibrinogen at Week 104 [ Time Frame: Week 0, week 104 ]
    Calculated as mean fibrinogen at week 104 - baseline. High fibrinogen is associated with greater cardiovascular risk

  • Change From Baseline in Adiponectin at Week 20 [ Time Frame: Week 0, week 20 ]
    Calculated as mean adiponectin at week 20-baseline. A low adiponectin level is associated with greater cardiovascular risk

  • Change From Baseline in Adiponectin at Week 104 [ Time Frame: Week 0, week 104 ]
    Calculated as mean adiponectin at week 104-baseline. A low adiponectin level is associated with greater cardiovascular risk

  • Change From Baseline in Waist Circumference at Week 20 [ Time Frame: Week 0, week 20 ]
    Calculated as mean waist circumference at week 20-baseline.

  • Change From Baseline in Waist Circumference at Week 104 [ Time Frame: Week 0, week 104 ]
    Calculated as mean waist circumference at week 104-baseline.

  • Change From Baseline in Blood Pressure at Week 20 [ Time Frame: Week 0, week 20 ]
    Calculated as mean blood pressure at week 20-baseline.

  • Change From Baseline in Blood Pressure at Week 104 [ Time Frame: Week 0, week 104 ]
    Calculated as mean blood pressure at week 104-baseline.


Enrollment: 564
Actual Study Start Date: January 10, 2007
Study Completion Date: April 30, 2009
Primary Completion Date: September 13, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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)
Drug: placebo
Injected s.c. (under the skin) once daily
Experimental: 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)
Drug: liraglutide
Injected s.c. (under the skin) once daily
Experimental: 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)
Drug: liraglutide
Injected s.c. (under the skin) once daily
Experimental: 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)
Drug: liraglutide
Injected s.c. (under the skin) once daily
Experimental: 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)
Drug: liraglutide
Injected s.c. (under the skin) once daily
Drug: placebo
Injected s.c. (under the skin) once daily
Active Comparator: 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)
Drug: orlistat
120 mg capsule. Administered thrice daily

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422058


Locations
Belgium
Novo Nordisk Investigational Site
Edegem, Belgium, 2650
Czechia
Novo Nordisk Investigational Site
Praha 1, Czechia, 116 94
Novo Nordisk Investigational Site
Praha 2, Czechia, 128 08
Denmark
Novo Nordisk Investigational Site
Frederiksberg C, Denmark, 1958
Novo Nordisk Investigational Site
Hvidovre, Denmark, 2650
Novo Nordisk Investigational Site
Århus C, Denmark, 8000
Finland
Novo Nordisk Investigational Site
Helsinki, Finland, 00270
Novo Nordisk Investigational Site
Kuopio, Finland, 70210
Novo Nordisk Investigational Site
Oulu, Finland, 90220
Netherlands
Novo Nordisk Investigational Site
Almere, Netherlands, 1311RL
Spain
Novo Nordisk Investigational Site
Barcelona, Spain, 08022
Novo Nordisk Investigational Site
Madrid, Spain, 28006
Novo Nordisk Investigational Site
Madrid, Spain, 28007
Novo Nordisk Investigational Site
Pamplona, Spain, 31008
Sweden
Novo Nordisk Investigational Site
Malmö, Sweden, 205 02
Novo Nordisk Investigational Site
Stockholm, Sweden, 141 86
United Kingdom
Novo Nordisk Investigational Site
Glasgow, United Kingdom, G322ER
Novo Nordisk Investigational Site
Luton, United Kingdom, LU4 0DZ
Novo Nordisk Investigational Site
Norwich, United Kingdom, NR4 7TJ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00422058     History of Changes
Obsolete Identifiers: NCT00480909
Other Study ID Numbers: NN8022-1807
2006-004481-13 ( EudraCT Number )
First Submitted: January 12, 2007
First Posted: January 15, 2007
Results First Submitted: April 27, 2010
Results First Posted: October 28, 2010
Last Update Posted: June 14, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Body Weight
Nutrition Disorders
Signs and Symptoms
Liraglutide
Orlistat
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents