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Completed

NCT Number: NCT00422058

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

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.

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Key information

Conditions

Metabolism and Nutrition Disorder Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Edegem, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

Injected s.c. (under the skin) once daily

Orlistat

Drug

120 mg capsule. Administered thrice daily

Placebo

Drug

Injected s.c. (under the skin) once daily

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. Change From Baseline in Fasting Insulin at Week 20

    Time frame: Week 0, week 20

    Calculated as mean fasting insulin at week 20 - baseline

  5. Change From Baseline in Fasting Insulin at Week 104

    Time frame: Week 0, week 104

    Calculated as mean fasting insulin at week 104 - baseline

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. Change From Baseline in Waist Circumference at Week 20

    Time frame: Week 0, week 20

    Calculated as mean waist circumference at week 20-baseline.

  17. Change From Baseline in Waist Circumference at Week 104

    Time frame: Week 0, week 104

    Calculated as mean waist circumference at week 104-baseline.

  18. Change From Baseline in Blood Pressure at Week 20

    Time frame: Week 0, week 20

    Calculated as mean blood pressure at week 20-baseline.

  19. Change From Baseline in Blood Pressure at Week 104

    Time frame: Week 0, week 104

    Calculated as mean blood pressure at week 104-baseline.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2009
First posted
Jan 15, 2007
Registry last updated
Nov 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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