Trial · Interventional

CompletedPhase 3Results postedRegistry data

Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes

NCTNCT01272219Other idNN8022-1839Other id2008-001049-24Other idU1111-1118-7871Other id2008

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 3,731 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Double masking
Countries: 29 countries
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Poland, Russia, Serbia and Montenegro, Serbia, South Africa, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Start: 1 Jun 2011
Primary completion: 18 Mar 2013
Completion: 2 Mar 2015
First posted: 7 Jan 2011 (estimated)
Last update posted: 19 Jan 2018
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

201120122013201420152016

Ph 3
Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: SCALE™ - Obesity and Pre-diabetes
NCT01272219
1 Jun 2011 to 2 Mar 2015

Registry summary

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

This trial is conducted in Africa, Asia, Europe, Oceania, North America and South America. The aim of this clinical trial is to evaluate the potential of liraglutide to induce and maintain weight loss over 56 weeks in obese subjects or overweight subjects with co-morbidities. Furthermore, the aim is to investigate the long term potential of liraglutide to delay the onset of type 2 diabetes in subjects diagnosed with pre-diabetes at baseline. Based on body mass index (BMI) and pre-diabetes status, subjects will be randomised to either 68 weeks (56 weeks of randomised treatment followed by a 12 week re-randomised treatment period) or 160 weeks of treatment (160 week treatment will only be applicable to subjects with pre-diabetes status at baseline).

Interventions

liraglutideDrug
placeboDrug
liraglutideDrug
placeboDrug

Arms5

Experimental
Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)
Experimental
Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)
Placebo comparator
Liraglutide Placebo, no Pre-diabetes
Experimental
Liraglutide 3.0mg, Pre-diabetes
Placebo comparator
Liraglutide Placebo, Pre-diabetes

Primary outcomes4

Outcomes the sponsor listed as primary.

Change From Baseline in Fasting Body Weight
Time frame · Week 0, Week 56
Registry description
The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period).
Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.
Time frame · At Week 56
Registry description
Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period).
Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight
Time frame · At 56 weeks
Registry description
Percentage of subjects losing \>10% of baseline fasting body weight after 56-weeks of treatment (main treatment period).
Proportion of Subjects With Onset of Type 2 Diabetes
Time frame · At 160 weeks
Registry description
Proportion of subjects with onset of Type 2 diabetes mellitus (T2DM) at week 160 (main + extension treatment period) among subjects with pre-diabetes at baseline - evaluated as time to onset of T2DM. Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).

Secondary outcomes(8)

Change From Baseline in Waist Circumference (cm)
Time frame · Week 0, Week 56
Registry description
The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period).
Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)
Time frame · Week 0, week 160
Registry description
The observed mean change from baseline in waist circumference (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
Pre-diabetes Status After 56 Weeks of Treatment
Time frame · Week 0, Week 56
Registry description
Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period).
Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment
Time frame · Week 0, week 160
Registry description
Observed percentage of subjects (subjects with pre-diabetes at baseline) with pre-diabetes status after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline)
Time frame · Week 0, week 160
Registry description
The observed mean change from baseline in fasting body weight (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline)
Time frame · At 160 weeks
Registry description
Percentage of subjects losing \>=5% and percentage of subjects losing \>10% of baseline fasting body weight (pre-diabetic subjects at baseline) after 160-weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period).
Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)
Time frame · Week 56, Week 68
Registry description
The observed mean change in fasting body weight (%) from week 56 to week 68 in re-randomised subjects (with no pre-diabetes at baseline) after 12-weeks of treatment (re-randomised treatment period).
Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes)
Time frame · Week 0, Week 68
Registry description
The observed mean change from baseline in fasting body weight (%) in re-randomised subjects (with no pre-diabetes at baseline) after 68 weeks of treatment (main + re-randomised treatment period).

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 56

Change From Baseline in Fasting Body Weight

Group	Value (percent change)	Spread
Liraglutide 3.0 mg (56-Week)	-7.98	6.67
Liraglutide Placebo (56-Week)	-2.62	5.74

Primary outcomeNumber· At Week 56

Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight.

Group	Value (percentage of subjects)
Liraglutide 3.0 mg (56-Week)	63.2
Liraglutide Placebo (56-Week)	27.1

Primary outcomeNumber· At 56 weeks

Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight

Group	Value (percentage of subjects)
Liraglutide 3.0 mg (56-Week)	33.1
Liraglutide Placebo (56-Week)	10.6

Primary outcomeNumber· At 160 weeks

Proportion of Subjects With Onset of Type 2 Diabetes

Group	Value (Subject)
Liraglutide 3.0 mg (160-Week)	26
Liraglutide Placebo (160-Week)	46

Secondary and other outcome results(4)

Secondary outcomeMean· Week 0, Week 56

Change From Baseline in Waist Circumference (cm)

Group	Value (cm)	Spread
Liraglutide 3.0 mg (56-Week)	-8.19	7.31
Liraglutide Placebo (56-Week)	-3.94	6.58

Secondary outcomeMean· Week 0, week 160

Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline)

Group	Value (cm)	Spread
Liraglutide 3.0 mg (160-Week)	-6.87	8.28
Liraglutide Placebo (160-Week)	-3.37	7.47

Secondary outcomeNumber· Week 0, Week 56

Pre-diabetes Status After 56 Weeks of Treatment

Group	Value (percentage of subjects)
Liraglutide 3.0 mg (56-Week)	78.3
Liraglutide Placebo (56-Week)	50.9

Secondary outcomeNumber· Week 0, week 160

Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment

Group	Value (percentage of subjects)
Liraglutide 3.0 mg (160-Week)	65.9
Liraglutide Placebo (160-Week)	36.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Liraglutide 3.0 mg, Pre-diabetesArm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.	–	230 / 1524	1342 / 1524
Liraglutide Placebo, Pre-diabetesArm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.	–	96 / 755	586 / 755
Liraglutide 3.0 mg, no Pre-diabetesArm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.	–	59 / 957	843 / 957
Liraglutide Placebo, no Pre-diabetesArm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.	–	19 / 487	345 / 487

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

Studies16

Studies that cite this trial.

Studies with results

11 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 source See results (2)

Indexing hint: Randomized controlled trial · 2018

5 results

Improvements in health-related quality of life over 3 years with liraglutide 3.0 mg compared with placebo in participants with overweight or obesity.

Kolotkin et al. 2018Clinical obesitycited by 32

PMID 29045079PMC5813214DOI 10.1111/cob.12226PUB-29045079

Free to read · publisher termsCC BY-NC-ND5 results

Read at source See results (5)

Indexing hint: Randomized controlled trial · 2017

5 results

Effect of weight reductions on estimated kidney function: Post-hoc analysis of two randomized trials.

von Scholten et al. 2017Journal of diabetes and its complicationscited by 6

PMID 28462892DOI 10.1016/j.jdiacomp.2017.04.003PUB-28462892

Full text at the publisher5 results

Publisher page See results (5)

Indexing hint: Randomized controlled trial · 2017

5 results

Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m²: A Post-hoc Analysis.

le Roux et al. 2017Obesity factscited by 28

PMID 29145215PMC5836203DOI 10.1159/000478099PUB-29145215

Free to read · publisher termsCC BY-NC-ND5 results

Read at source See results (5)

Indexing hint: Randomized controlled trial · 2016

7 results

Efficacy and safety of liraglutide 3.0 mg for weight management are similar across races: subgroup analysis across the SCALE and phase II randomized trials.

Ard et al. 2016Diabetes, obesity & metabolismcited by 33

PMID 26744025PMC6084344DOI 10.1111/dom.12632PUB-26744025

Free to read · publisher termsCC BY-NC-ND7 results

Read at source See results (7)

Indexing hint: Randomized controlled trial · 2016

5 results

Exposure-response analyses of liraglutide 3.0 mg for weight management.

Wilding et al. 2016Diabetes, obesity & metabolismcited by 74

PMID 26833744PMC5069568DOI 10.1111/dom.12639PUB-26833744

Free to read · publisher termsCC BY-NC-ND5 results

Read at source See results (5)

Indexing hint: Randomized controlled trial · 2016

9 results

Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis.

Overgaard et al. 2016Clinical pharmacokineticscited by 44

PMID 27193270PMC5069304DOI 10.1007/s40262-016-0410-7PUB-27193270

Free to read · publisher termsCC BY-NC9 results

Read at source See results (9)

Indexing hint: Randomized controlled trial · 2016

7 results

Improvements in health-related quality of life with liraglutide 3.0 mg compared with placebo in weight management.

Kolotkin et al. 2016Clinical obesitycited by 30

PMID 27198973PMC5084798DOI 10.1111/cob.12146PUB-27198973

Free to read · publisher termsCC BY-NC-ND7 results

Read at source See results (7)

Indexing hint: Randomized controlled trial · 2016

8 results

EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS.

O'Neil et al. 2016Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologistscited by 18

PMID 27482610DOI 10.4158/ep151181.orPUB-27482610

Full text at the publisher8 results

Publisher page See results (8)

Indexing hint: Randomized controlled trial · 2016

9 results

Early Weight Loss with Liraglutide 3.0 mg Predicts 1-Year Weight Loss and is Associated with Improvements in Clinical Markers.

Fujioka et al. 2016Obesity (Silver Spring, Md.)cited by 101

PMID 27804269PMC5129670DOI 10.1002/oby.21629PUB-27804269

Free to read · publisher termsCC BY-NC-ND9 results

Read at source See results (9)

Indexing hint: Randomized controlled trial · 2015

6 results

A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management.

Pi-Sunyer et al. 2015The New England journal of medicinecited by 1,954

PMID 26132939DOI 10.1056/nejmoa1411892PUB-26132939

Rights unknown6 results

Source link See results (6)

More studies

5 studies on this page

Indexing hint: Review · 2022

Glucagon-like Peptide-1 Receptor Analogues for the Treatment of Obesity.

Williams et al. 2022TouchREVIEWS in endocrinologycited by 6

PMID 35975210PMC9354511DOI 10.17925/ee.2022.18.1.43PUB-35975210

CC BY

Download PDF

PubMed tag: none · 2017

Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects.

Bays et al. 2017Current medical research and opinioncited by 38

PMID 27817208DOI 10.1080/03007995.2016.1251892PUB-27817208

Full text at the publisher

Publisher page

Indexing hint: Randomized controlled trial · 2017

Corrected

3 years of liraglutide versus placebo for type 2 diabetes risk reduction and weight management in individuals with prediabetes: a randomised, double-blind trial.

le Roux et al. 2017Lancet (London, England)cited by 618

PMID 28237263DOI 10.1016/s0140-6736(17)30069-7PUB-28237263

Full text at the publisher

Publisher page Read the notice

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

Indexing hint: Review · 2016

Missing data in clinical trials for weight management.

McEvoy et al. 2016Journal of biopharmaceutical statisticscited by 23

PMID 26418188DOI 10.1080/10543406.2015.1094814PUB-26418188

Full text at the publisher

Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedKral P, Holst-Hansen T, Olivieri AV, Ivanescu C, Lamotte M, Larsen S. The Correlation Between Body Mass Index and Health-Related Quality of Life: Data from Two Weight Loss Intervention Studies. Adv Ther. 2024 Nov;41(11):4228-4247. doi: 10.1007/s12325-024-02932-8. Epub 2024 Sep 24. PMID 39316288

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Informed consent obtained * Body Mass Index (BMI) of 30.0 kg/m\^2 or above * Body Mass Index (BMI) of 27 kg/m\^2 or above in the presence of co-morbidities of treated or untreated dyslipidemia and/or hypertension * Stable body weight * Preceding failed dietary effort Exclusion Criteria: * Known type 1 or type 2 diabetes * Glycosylated haemoglobin (HbA1c) of 6.5 % or above (Screening visit 1) or FPG of 126 mg/dL (7 mmol/L) or above (Screening visit 2) or 2 hour post-challenge (OGTT) plasma glucose of 200 mg/dL (11.1 mmol/L) or above (Screening visit 2) * Screening calcitonin of 50 ng/L or above * Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC) * Personal history of non-familial medullary thyroid carcinoma * History of acute or chronic pancreatitis * Obesity induced by drug treatment * Use of approved weight lowering pharmacotherapy * Previous surgical treatment of obesity * History of major depressive disorder or suicide attempt * Uncontrolled hypertension (systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above)

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