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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT00422058 (opens ClinicalTrials.gov in a new tab)Other idNN8022-1807Other id2006-004481-13
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
564 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
8 countries

Belgium, Czechia, Denmark, Finland, Netherlands, Spain, Sweden, United Kingdom

Start
10 Jan 2007
Primary completion
13 Sept 2007
Completion
30 Apr 2009
First posted
15 Jan 2007 (estimated)
Last update posted
1 Nov 2017
Conditions
Metabolism and Nutrition Disorder · Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2007200820092010
  1. Ph 2

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

    NCT00422058

    10 Jan 2007 to 30 Apr 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • liraglutideDrug
  • orlistatDrug
  • placeboDrug

Arms6

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Mean Change From Baseline in Body Weight at Week 20

    Time frame · Week 0, week 20

    Registry description

    Calculated as mean body weight at week 20 - baseline

Secondary outcomes(19)

  1. Mean Change From Baseline in Body Weight at Week 104

    Time frame · Week 0, week 104

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    Calculated as mean blood pressure at week 104-baseline.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Week 0, week 20

Mean Change From Baseline in Body Weight at Week 20

GroupValue (kg)Spread
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg97.312.3
Lira 1.2 mg/Lira 3.0 mg96.413.4
Lira 1.8 mg/Lira 3.0 mg98.012.5
Lira 2.4 mg/Lira 3.0 mg98.413.1
Liraglutide 3.0 mg97.513.8
Orlistat96.011.7
Secondary and other outcome results(7)
Secondary outcomeMean· Week 0, week 104

Mean Change From Baseline in Body Weight at Week 104

GroupValue (kg)Spread
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg97.312.3
Lira 1.2 mg/Lira 3.0 mg96.413.4
Lira 1.8 mg/Lira 3.0 mg98.012.5
Lira 2.4 mg/Lira 3.0 mg98.413.1
Liraglutide 3.0 mg97.513.8
Orlistat96.011.7
Secondary outcomeMean· Week 0, week 20

Change From Baseline in Fasting Plasma Glucose at Week 20

GroupValue (mmol/L)Spread
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg5.420.81
Lira 1.2 mg/Lira 3.0 mg5.300.61
Lira 1.8 mg/Lira 3.0 mg5.290.56
Lira 2.4 mg/Lira 3.0 mg5.270.57
Liraglutide 3.0 mg5.360.61
Orlistat5.30.51
Secondary outcomeMean· Week 0, week 104

Change From Baseline in Fasting Plasma Glucose at Week 104

GroupValue (mmol/L)Spread
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg5.420.81
Lira 1.2 mg/Lira 3.0 mg5.300.61
Lira 1.8 mg/Lira 3.0 mg5.290.56
Lira 2.4 mg/Lira 3.0 mg5.270.57
Liraglutide 3.0 mg5.360.61
Orlistat5.300.51
Secondary outcomeMean· Week 0, week 20

Change From Baseline in Fasting Insulin at Week 20

GroupValue (pmol/L)Spread
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg99.5129.2
Lira 1.2 mg/Lira 3.0 mg82.943.0
Lira 1.8 mg/Lira 3.0 mg85.749.5
Lira 2.4 mg/Lira 3.0 mg88.743.3
Liraglutide 3.0 mg89.151.9
Orlistat85.548.3
Secondary outcomeMean· Week 0, week 104

Change From Baseline in Fasting Insulin at Week 104

GroupValue (pmol/L)Spread
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg99.5129.2
Lira 1.2 mg/Lira 3.0 mg82.943.0
Lira 1.8 mg/Lira 3.0 mg85.749.5
Lira 2.4 mg/Lira 3.0 mg88.743.3
Liraglutide 3.0 mg89.151.9
Orlistat85.548.3
Secondary outcomeMean· Week 0, week 20

Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20

GroupValue (percentage (%) of total haemoglobin)Spread
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg5.600.38
Lira 1.2 mg/Lira 3.0 mg5.580.33
Lira 1.8 mg/Lira 3.0 mg5.600.40
Lira 2.4 mg/Lira 3.0 mg5.540.34
Liraglutide 3.0 mg5.570.40
Orlistat5.550.32
Secondary outcomeMean· Week 0, week 104

Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104

GroupValue (percentage (%) of total haemoglobin)Spread
Lira Placebo/Lira 2.4 mg/Lira 3.0 mg5.600.38
Lira 1.2 mg/Lira 3.0 mg5.580.33
Lira 1.8 mg/Lira 3.0 mg5.600.40
Lira 2.4 mg/Lira 3.0 mg5.540.34
Liraglutide 3.0 mg5.570.40
Orlistat5.550.32

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Lira Placebo/Lira 2.4 mg/Lira 3.0 mgLiraglutide 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 / 9890 / 98
Lira 1.2 mg/Lira 3.0 mgLiraglutide 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 / 9590 / 95
Lira 1.8 mg/Lira 3.0 mgLiraglutide 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 / 9086 / 90
Lira 2.4 mg/Lira 3.0 mgLiraglutide 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 / 9389 / 93
Liraglutide 3.0 mgLiraglutide 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 / 9390 / 93
OrlistatOrlistat 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 / 9589 / 95

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies6

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Meta-analysis (pooled) · 2018

2 results

Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials.

Davies et al. 2018Diabetes, obesity & metabolismcited by 80

PMID 28950422PMC5836948DOI 10.1111/dom.13125PUB-28950422

Free to read · publisher termsCC BY-NC2 results
Read at sourceSee results (2)

Indexing hint: Randomized controlled trial · 2014

9 results

Tolerability of nausea and vomiting and associations with weight loss in a randomized trial of liraglutide in obese, non-diabetic adults.

Lean et al. 2014International journal of obesity (2005)cited by 135

PMID 23942319PMC4010971DOI 10.1038/ijo.2013.149PUB-23942319

Free to read · publisher termsCC BY-NC-ND9 results
Read at sourceSee results (9)

More studies

4 studies on this page

PubMed tag: none · 2017

Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials.

O'Neil et al. 2017Diabetes, obesity & metabolismcited by 93

PMID 28386912PMC5655710DOI 10.1111/dom.12963PUB-28386912

Free to read · publisher termsCC BY-NC-ND
Read at source

PubMed tag: none · 2017

Corrected

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.

Steinberg et al. 2017Diabetes carecited by 55

PMID 28473337DOI 10.2337/dc16-2684PUB-28473337

Full text at the publisher
Publisher pageRead the notice

Indexing hint: Randomized controlled trial · 2012

Corrected

Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide.

Astrup et al. 2012International journal of obesity (2005)cited by 497

PMID 21844879PMC3374073DOI 10.1038/ijo.2011.158PUB-21844879

Free to read · publisher termsCC BY-NC-ND
Read at sourceRead the notice

Indexing hint: Randomized controlled trial · 2009

Corrected

Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study.

Astrup et al. 2009Lancet (London, England)cited by 810

PMID 19853906DOI 10.1016/s0140-6736(09)61375-1PUB-19853906

Full text at the publisher
Publisher pageRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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