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

NCTNCT00781937Other idNN8022-1923

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Overview

Status: Completed
Phase: Phase 3
Enrollment: 422 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Double masking
Countries: 2 countries
United States, Canada
Start: 30 Oct 2008
Primary completion: 1 Sept 2010
Completion: 1 Sept 2010
First posted: 29 Oct 2008 (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

2008200920102011

Ph 3
Comparison of Liraglutide Versus Placebo in Weight Loss Maintenance in Obese Subjects: SCALE - Maintenance
NCT00781937
30 Oct 2008 to 1 Sept 2010

Registry summary

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

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).

Interventions

liraglutideDrug
placeboDrug

Arms2

Experimental
Lira 3.0 mg
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
Placebo comparator
Placebo
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

Primary outcomes3

Outcomes the sponsor listed as primary.

Mean Percentage Change in Fasting Body Weight From Baseline
Time frame · Week 0, week 56
Registry description
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0
Time frame · Week 0, week 56
Registry description
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.
Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0
Time frame · Week 0, week 56
Registry description
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.

Secondary outcomes(20)

Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0
Time frame · Week 0, week 56
Registry description
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0
Time frame · Week 0, week 56
Registry description
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0
Time frame · Week 0, week 56
Registry description
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0
Time frame · Week 0, week 56
Registry description
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0
Time frame · Week 0, week 56
Registry description
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Change From Baseline in Fasting Weight
Time frame · Week 0, week 56
Registry description
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Period
Time frame · Week 0, week 68
Registry description
Subjects were weighed having fasted (consumed only water) since midnight the night before the visit.
Change From Baseline in Blood Pressure
Time frame · Week 0, week 56
Change From Baseline in Pulse
Time frame · Week 0, week 56
Change From Baseline in Fasting Lipid Profile: Triglycerides
Time frame · Week 0, week 56
Registry description
Subjects were tested having fasted (consumed only water) since midnight the night before the visit.
Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterol
Time frame · Week 0, week 56
Registry description
Subjects were tested having fasted (consumed only water) since midnight the night before the visit.
Change From Baseline in Fasting Lipid Profile: Total Cholesterol
Time frame · Week 0, week 56
Registry description
Subjects were tested having fasted (consumed only water) since midnight the night before the visit.
Change From Baseline in Cardiovascular Biomarker: High Sensitivity C-reactive Protein (hsCRP)
Time frame · Week 0, week 56
Percentage of Subjects Meeting Metabolic Syndrome Criteria: ATP (Adult Treatment Panel) III at Week 56
Time frame · Week 56
Registry description
Metabolic syndrome status required at least 3 of 5 criteria met: Waist circumference (men ≥102cm, women ≥88cm); Triglycerides \>1.7mmol/L; High density lipoprotein cholesterol (men \<0.9mmol/L, women \<1.1mmol/L) or on drug therapy; Blood pressure ≥130mmHg systolic or ≥85mmHg diastolic or on drug therapy; Fasting glucose ≥5.5mmol/L or on drug therapy.
Change From Baseline in Waist Circumference
Time frame · Week 0, week 56
Change From Baseline in Body Mass Index (BMI)
Time frame · Week 0, week 56
Change From Baseline in Glycaemic Control Parameter: HOMA-B (Homeostasis Model Assessment - Beta Cell Function)
Time frame · Week 0, week 56
Registry description
Change in beta-cell function percent values from Week 0 (X%) to Week 56 (Y%) was calculated \[X% - Y%\]. Beta-cell function was derived from fasting plasma glucose readings in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged \<35 years have median beta-cell function indexed at 100%.
Change From Baseline in Glycaemic Control Parameter: HOMA-IR (Homeostasis Model Assessment - Insulin Resistance)
Time frame · Week 0, week 56
Registry description
Change in insulin resistance values from Week 0 (X) to Week 56 (Y) was calculated \[X - Y\]. Insulin resistance was derived from fasting serum insulin levels in blood samples using the HOMA method, which is based on the assumption that normal-weight subjects without diabetes aged \<35 years have median insulin resistance indexed at 1.00.
Change From Baseline in Glycaemic Control Parameter: Fasting Plasma Glucose (FPG)
Time frame · Week 0, week 56
Registry description
Subjects were tested having fasted (consumed only water) since midnight the night before the visit.
Change From Baseline in Glycaemic Control Parameter: Fasting Serum Insulin
Time frame · Week 0, week 56
Registry description
Subjects were tested having fasted (consumed only water) since midnight the night before the visit.

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 outcomeLeast squares mean· Week 0, week 56

Mean Percentage Change in Fasting Body Weight From Baseline

Group	Value (percentage)	Spread
Lira 3.0 mg	-6.11	0.66
Placebo	-0.05	0.63

Primary outcomeNumber· Week 0, week 56

Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0

Group	Value (percentage of subjects)
Lira 3.0 mg	80.8
Placebo	47.9

Primary outcomeNumber· Week 0, week 56