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

NCT ID: NCT00422058

Last Updated: 2017-11-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

564 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-10

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Metabolism and Nutrition Disorder Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

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)

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

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

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)

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

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

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)

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

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

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)

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

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

placebo

Intervention Type DRUG

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

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)

Group Type ACTIVE_COMPARATOR

orlistat

Intervention Type DRUG

120 mg capsule. Administered thrice daily

Interventions

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liraglutide

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

Intervention Type DRUG

orlistat

120 mg capsule. Administered thrice daily

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Edegem, , Belgium

Site Status

Novo Nordisk Investigational Site

Prague, , Czechia

Site Status

Novo Nordisk Investigational Site

Prague, , Czechia

Site Status

Novo Nordisk Investigational Site

Århus C, , Denmark

Site Status

Novo Nordisk Investigational Site

Frederiksberg C, , Denmark

Site Status

Novo Nordisk Investigational Site

Hvidovre, , Denmark

Site Status

Novo Nordisk Investigational Site

Helsinki, , Finland

Site Status

Novo Nordisk Investigational Site

Kuopio, , Finland

Site Status

Novo Nordisk Investigational Site

Oulu, , Finland

Site Status

Novo Nordisk Investigational Site

Almere Stad, , Netherlands

Site Status

Novo Nordisk Investigational Site

Barcelona, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Pamplona, , Spain

Site Status

Novo Nordisk Investigational Site

Malmo, , Sweden

Site Status

Novo Nordisk Investigational Site

Stockholm, , Sweden

Site Status

Novo Nordisk Investigational Site

Glasgow, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Luton, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Norwich, , United Kingdom

Site Status

Countries

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Belgium Czechia Denmark Finland Netherlands Spain Sweden United Kingdom

References

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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.

Reference Type RESULT
PMID: 21844879 (View on PubMed)

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.

Reference Type RESULT
PMID: 19853906 (View on PubMed)

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.

Reference Type RESULT
PMID: 23942319 (View on PubMed)

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.

Reference Type RESULT
PMID: 28473337 (View on PubMed)

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.

Reference Type RESULT
PMID: 28386912 (View on PubMed)

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.

Reference Type RESULT
PMID: 28950422 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2006-004481-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN8022-1807

Identifier Type: -

Identifier Source: org_study_id

NCT00480909

Identifier Type: -

Identifier Source: nct_alias