NCT00781937|CompletedPhase 3Results

Comparison of Liraglutide Versus Placebo in Weight Loss Maintenance in Obese Subjects: SCALE - Maintenance

Effect of Liraglutide on Long-term Weight Maintenance and Additional Weight Loss Induced by a 4 to 12 Week Low Calorie Diet in Obese Subjects; A 56 Week Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Trial With a 12 Week Follow-up Period

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

NN8022-1923

Study Type

interventional

Target

422

Locations

2 countries

Sites

Timeline

RegisteredOct 2008

StartedOct 2008

CompletionSep 2010

Brief Summary

This trial is conducted in North America. The aim of this clinical trial is to evaluate the potential of liraglutide to maintain long term weight loss in obese non-diabetic subjects, as well as in overweight subjects who have medical problems such as hypertension (high blood pressure) or dyslipidaemia (an abnormal amount of lipids in the blood). Trial has following trial periods: A 12-week run-in period (from week -12 to week 0) followed by a 56-week main trial period (weeks 0-56) and a 12-week follow-up period (weeks 56-68).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

422

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Oct 2008

Geographic Reach

2 countries

37 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

October 28, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2008

Completed

1 day until next milestone

Study Start

First participant enrolled

October 30, 2008

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

November 28, 2011

Completed

Last Updated

November 1, 2017

Status Verified

September 1, 2017

Enrollment Period

1.8 years

First QC Date

October 28, 2008

Results QC Date

September 1, 2011

Last Update Submit

September 29, 2017

Conditions

Metabolism and Nutrition Disorder Obesity

Outcome Measures

Primary Outcomes (3)

Mean Percentage Change in Fasting Body Weight From Baseline
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Week 0, week 56
Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0
Subjects who had a weight regain less than or equal to 0.5% of weight from Week 0 were regarded as maintenance of run-in fasting weight loss. Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Week 0, week 56
Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Week 0, week 56

Secondary Outcomes (23)

Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0
Week 0, week 56
Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0
Week 0, week 56
Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0
Week 0, week 56
Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0
Week 0, week 56
Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0
Week 0, week 56
+18 more secondary outcomes

Study Arms (2)

Lira 3.0 mg

EXPERIMENTAL

A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached

Drug: liraglutide

Placebo

PLACEBO COMPARATOR

A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period

Drug: placebo

Interventions

liraglutideDRUG

Liraglutide 3.0 mg per day administered in a 6.0 mg/mL, 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily

Lira 3.0 mg

placeboDRUG

Liraglutide placebo 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Body Mass Index (BMI) of either 30 kg/m\^2 or more or BMI of less than 30 kg/m\^2 to 27 kg/m\^2 with presence of co-morbidities
Stable body weight during the previous 3 months (less than 5 kg self-reported weight change)
Previously undergone dietary weight loss and was not able to maintain reduced weight

You may not qualify if:

Diagnosis of type 1 or type 2 diabetes
Previous treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (including liraglutide or exenatide), within the last 3 months
Visit 1 thryoid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L
History of chronic pancreatitis or idiopathic acute pancreatitis
Obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome)
Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial
Current participation in an organized diet reduction program (or within the last 3 months)
Currently using or have used within three months before this trial: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phenteremine, or metformin
Previous surgical treatment for obesity (excluding liposuction if performed more than one year before trial entry)
History of major depressive disorder or a PHQ-9 (Patient Health Questionnaire-9) score of more than 15 within the last 2 years or history of other severe psychiatric disorders or diagnosis of an eating disorder
Subjects with a lifetime history of a suicide attempt or history of any suicidal behavior within the past month before entry into the trial

Contact the study team to confirm eligibility.