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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00422058
First received: January 12, 2007
Last updated: June 26, 2012
Last verified: June 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Calculated as mean fasting insulin at week 20 - baseline

  • Change From Baseline in Fasting Insulin at Week 104 [ Time Frame: Week 0, week 104 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Calculated as mean waist circumference at week 20-baseline.

  • Change From Baseline in Waist Circumference at Week 104 [ Time Frame: Week 0, week 104 ] [ Designated as safety issue: No ]
    Calculated as mean waist circumference at week 104-baseline.

  • Change From Baseline in Blood Pressure at Week 20 [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
    Calculated as mean blood pressure at week 20-baseline.

  • Change From Baseline in Blood Pressure at Week 104 [ Time Frame: Week 0, week 104 ] [ Designated as safety issue: No ]
    Calculated as mean blood pressure at week 104-baseline.


Enrollment: 564
Study Start Date: January 2007
Study Completion Date: April 2009
Primary Completion Date: September 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422058

Locations
Belgium
Edegem, Antwerp, Belgium
Czech Republic
Prague, Czech Republic
Denmark
Copenhagen, Denmark
Frederiksberg, Denmark
Finland
Helsinki, Finland
Netherlands
Almere, Netherlands
Spain
Barcelona, Spain
Sweden
Stockholm, Sweden
United Kingdom
Glasgow, United Kingdom
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Mads F. Rasmussen, MD, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00422058     History of Changes
Obsolete Identifiers: NCT00480909
Other Study ID Numbers: NN8022-1807, 2006-004481-13
Study First Received: January 12, 2007
Results First Received: April 27, 2010
Last Updated: June 26, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Czech Republic: State Institute for Drug Control
Spain: Spanish Agency for Medicines
Belgium: FPS of Public Health, Directorate General for the protection of Public Health: Medicines
Sweden: Medical Products Agency
Netherlands: Medicines Evaluation Board, Dutch Health Care Inspectorate

Additional relevant MeSH terms:
Body Weight
Nutrition Disorders
Obesity
Signs and Symptoms
Overnutrition
Overweight
Orlistat
Glucagon-Like Peptide 1
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014