Metabolism and Nutrition DisorderPhase 2NCT00422058
The Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes
A Phase 2 study testing liraglutide and orlistat in people with Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 19 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolism and Nutrition Disorder, Obesity
- What is being tested?
- liraglutide and orlistat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 564 participants
- Where
- 19 sitesin 8 countries
- Study dates
- 10 Jan 2007to 30 Apr 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
19 sites in 8 countries.
19 sites in 8 countries
Spain4 sites
Novo Nordisk Investigational Site
Barcelona, 08022
Novo Nordisk Investigational Site
Madrid, 28006
Novo Nordisk Investigational Site
Madrid, 28007
Novo Nordisk Investigational Site
Pamplona, 31008
Denmark3 sites
Novo Nordisk Investigational Site
Århus C, 8000
Novo Nordisk Investigational Site
Frederiksberg C, 1958
Novo Nordisk Investigational Site
Hvidovre, 2650
Finland3 sites
Novo Nordisk Investigational Site
Helsinki, 00270
Novo Nordisk Investigational Site
Kuopio, 70210
Novo Nordisk Investigational Site
Oulu, 90220
United Kingdom3 sites
Novo Nordisk Investigational Site
Glasgow, G322ER
Novo Nordisk Investigational Site
Luton, LU4 0DZ
Novo Nordisk Investigational Site
Norwich, NR4 7TJ
Czechia2 sites
Novo Nordisk Investigational Site
Prague, 116 94
Novo Nordisk Investigational Site
Prague, 128 08
Sweden2 sites
Novo Nordisk Investigational Site
Malmö, 205 02
Novo Nordisk Investigational Site
Stockholm, 141 86
About this study
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
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.
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Being tested
- liraglutide, orlistat, placebo
- Medical subject headings
- Nutrition Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
Injected s.c. (under the skin) once daily
orlistatDrug
120 mg capsule. Administered thrice daily
placeboDrug
Injected s.c. (under the skin) once daily
| Study group | Role | What they receive |
|---|---|---|
| Lira placebo/Lira 2.4 mg/Lira 3.0 mg | Placebo comparator | 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) Receives: Drug: placebo |
| Lira 1.2 mg/Lira 3.0 mg | Experimental | 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) Receives: Drug: liraglutide |
| Lira 1.8 mg/Lira 3.0 mg | Experimental | 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) Receives: Drug: liraglutide |
| Lira 2.4 mg/Lira 3.0 mg | Experimental | 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) Receives: Drug: liraglutide |
| Liraglutide 3.0 mg | Experimental | 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) Receives: Drug: liraglutide; Drug: placebo |
| Orlistat | Active comparator | 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) Receives: Drug: orlistat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Body Weight at Week 20
Calculated as mean body weight at week 20 - baseline
Measured: Week 0, week 20
Secondary outcomes (19)
Mean Change From Baseline in Body Weight at Week 104
Calculated as mean body weight at week 104 - baseline
Measured: Week 0, week 104
Change From Baseline in Fasting Plasma Glucose at Week 20
Calculated as mean fasting plasma glucose at week 20 - baseline
Measured: Week 0, week 20
Change From Baseline in Fasting Plasma Glucose at Week 104
Calculated as mean fasting plasma glucose at week 104 - baseline
Measured: Week 0, week 104
Change From Baseline in Fasting Insulin at Week 20
Calculated as mean fasting insulin at week 20 - baseline
Measured: Week 0, week 20
Change From Baseline in Fasting Insulin at Week 104
Calculated as mean fasting insulin at week 104 - baseline
Measured: Week 0, week 104
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20
Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 20 - baseline
Measured: Week 0, week 20
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104
Calculated as mean HbA1c (glycosylated haemoglobin A1c) at week 104 - baseline
Measured: Week 0, week 104
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20
Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 20-baseline. High hsCRP level is associated with greater cardiovascular risk
Measured: Week 0, week 20
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104
Calculated as mean hsCRP (highly sensitive C-reactive protein) at week 104- baseline. High hsCRP level is associated with greater cardiovascular risk
Measured: Week 0, week 104
Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20
Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 20-baseline. High PAI-1 is associated with greater cardiovascular risk
Measured: Week 0, week 20
Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104
Calculated as mean PAI-1 (plasminogen activator inhibitor 1) at week 104-baseline. High PAI-1 is associated with greater cardiovascular risk
Measured: Week 0, week 104
Change From Baseline in Fibrinogen at Week 20
Calculated as mean fibrinogen at week 20 - baseline. High fibrinogen is associated with greater cardiovascular risk
Measured: Week 0, week 20
Change From Baseline in Fibrinogen at Week 104
Calculated as mean fibrinogen at week 104 - baseline. High fibrinogen is associated with greater cardiovascular risk
Measured: Week 0, week 104
Change From Baseline in Adiponectin at Week 20
Calculated as mean adiponectin at week 20-baseline. A low adiponectin level is associated with greater cardiovascular risk
Measured: Week 0, week 20
Change From Baseline in Adiponectin at Week 104
Calculated as mean adiponectin at week 104-baseline. A low adiponectin level is associated with greater cardiovascular risk
Measured: Week 0, week 104
Change From Baseline in Waist Circumference at Week 20
Calculated as mean waist circumference at week 20-baseline.
Measured: Week 0, week 20
Change From Baseline in Waist Circumference at Week 104
Calculated as mean waist circumference at week 104-baseline.
Measured: Week 0, week 104
Change From Baseline in Blood Pressure at Week 20
Calculated as mean blood pressure at week 20-baseline.
Measured: Week 0, week 20
Change From Baseline in Blood Pressure at Week 104
Calculated as mean blood pressure at week 104-baseline.
Measured: Week 0, week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2007 (estimated)
- Study start10 Jan 2007
- Primary completion13 Sep 2007
- Study completion30 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Metabolism and Nutrition DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 564 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422058
- Sponsor's protocol ID
- NN8022-1807
- Other IDs
- 2006-004481-13
- Status last verified
- Sep 2017
- First submitted
- 12 Jan 2007
- Last updated
- 1 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21844879Astrup 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.
PubMed 19853906Lean 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.
PubMed 23942319Steinberg 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.
PubMed 28473337O'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.
PubMed 28386912Davies 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.
PubMed 28950422
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00422058
- Acronym / sponsor ID
- NN8022-1807
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2007 (actual)
- Primary completion
- 13 Sep 2007 (actual)
- Study completion
- 30 Apr 2009 (actual)
- First posted
- 15 Jan 2007 (estimated)
- Results
- Posted 28 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Lira placebo/Lira 2.4 mg/Lira 3.0 mg | Placebo comparator | Drug: placeboLiraglutide 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) |
| Lira 1.2 mg/Lira 3.0 mg | Experimental | Drug: liraglutideLiraglutide 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) |
| Lira 1.8 mg/Lira 3.0 mg | Experimental | Drug: liraglutideLiraglutide 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) |
| Lira 2.4 mg/Lira 3.0 mg | Experimental | Drug: liraglutideLiraglutide 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) |
| Liraglutide 3.0 mg | Experimental | Drug: liraglutide, Drug: placeboLiraglutide 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) |
| Orlistat | Active comparator | Drug: 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liraglutideInjected s.c. (under the skin) once daily | Drug | Lira 1.2 mg/Lira 3.0 mg, Lira 1.8 mg/Lira 3.0 mg, Lira 2.4 mg/Lira 3.0 mg, Liraglutide 3.0 mg |
| orlistat120 mg capsule. Administered thrice daily | Drug | Orlistat |
| placeboInjected s.c. (under the skin) once daily | Drug | Lira placebo/Lira 2.4 mg/Lira 3.0 mg, Liraglutide 3.0 mg |
Primary outcome
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
19 secondary outcomes
Mean Change From Baseline in Body Weight at Week 104
Time frame: Week 0, week 104
Change From Baseline in Fasting Plasma Glucose at Week 20
Time frame: Week 0, week 20
Change From Baseline in Fasting Plasma Glucose at Week 104
Time frame: Week 0, week 104
Change From Baseline in Fasting Insulin at Week 20
Time frame: Week 0, week 20
Change From Baseline in Fasting Insulin at Week 104
Time frame: Week 0, week 104
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 20
Time frame: Week 0, week 20
Change From Baseline in HbA1c (Glycosylated Haemoglobin A1c) at Week 104
Time frame: Week 0, week 104
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 20
Time frame: Week 0, week 20
Change From Baseline in hsCRP (Highly Sensitive C-reactive Protein) at Week 104
Time frame: Week 0, week 104
Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 20
Time frame: Week 0, week 20
Change From Baseline in PAI-1 (Plasminogen Activator Inhibitor 1) at Week 104
Time frame: Week 0, week 104
Change From Baseline in Fibrinogen at Week 20
Time frame: Week 0, week 20
Change From Baseline in Fibrinogen at Week 104
Time frame: Week 0, week 104
Change From Baseline in Adiponectin at Week 20
Time frame: Week 0, week 20
Change From Baseline in Adiponectin at Week 104
Time frame: Week 0, week 104
Change From Baseline in Waist Circumference at Week 20
Time frame: Week 0, week 20
Change From Baseline in Waist Circumference at Week 104
Time frame: Week 0, week 104
Change From Baseline in Blood Pressure at Week 20
Time frame: Week 0, week 20
Change From Baseline in Blood Pressure at Week 104
Time frame: Week 0, week 104
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21844879Astrup 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.
- Results publication: PubMed 19853906Astrup 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.
- Results publication: PubMed 23942319Lean 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.
- Results publication: PubMed 28473337Steinberg 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.
- Results publication: PubMed 28386912O'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.
- Results publication: PubMed 28950422Davies 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.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
19 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing liraglutide and orlistat in people with Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 19 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Spain, Denmark, Finland, United Kingdom, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Body Weight at Week 20 (time frame: Week 0, week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00422058, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.