Phase 3 · Liraglutide

NCT00781937 trial results

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

Mean Percentage Change in Fasting Body Weight From Baseline (percentage), Week 0, week 56. Lira 3.0 mg: -6.11; Placebo: -0.05.

Participants
422
Status
completed
Completed
2010-09-01
Sponsor
Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT00781937), updated at source Nov 1, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT00781937 measured first

Mean Percentage Change in Fasting Body Weight From Baselinepercentage · Week 0, week 56 · least squares mean
Lira 3.0 mgn=194Placebon=188
-6.11(0.66)-0.05(0.63)
Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0percentage of subjects · Week 0, week 56 · number
Lira 3.0 mgn=194Placebon=188
80.847.9
Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0percentage of subjects · Week 0, week 56 · number
Lira 3.0 mgn=194Placebon=188
50.521.9
Side effects by arm

Side effects in NCT00781937

Percent of participants affected, Treatment emergent adverse events were defined as occurring before randomisation and increasing in severity during treatment, or had onset on or after first day of randomised treatment and no later.... The most common events the registry lists.

EventLira 3.0 mgPlacebo
Any serious event4.2%2.4%
Nausea47.6%17.1%
Constipation26.9%12.4%
Nasopharyngitis17%22.4%
Diarrhoea17.9%12.4%
Vomiting16.5%2.4%
Sinusitis7.5%12.9%
Headache12.7%12.4%
Upper Respiratory Tract Infection12.3%11%
Injection Site Haematoma8%11.4%
Influenza7.1%10.5%
Dizziness10.4%8.6%
Decreased Appetite9.9%1.4%
Back Pain5.2%9.5%
Dyspepsia9.4%1.9%
Fatigue8%5.2%
Urinary Tract Infection7.1%5.2%
Abdominal Pain6.6%1.4%
Cough6.6%5.2%
Arthralgia5.7%6.2%
Abdominal Distension6.1%3.8%
Bronchitis3.3%5.2%
Eructation5.2%0%
Flatulence5.2%3.8%
Injection Site Pain3.8%5.2%
Muscle Strain5.2%4.8%
Secondary outcomes

What else it measured

Percentage of Subjects Who Lost More Than 10% of Fasting Body Weight From Week 0percentage of subjects · Week 0, week 56 · number
Lira 3.0 mgn=194Placebon=188
26.16.3
Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 5% From Week 0percentage of subjects · Week 0, week 56 · number
Lira 3.0 mgn=207Placebon=206
1.917.5
Percentage of Subjects With Weight Regain (Fasting) More Than or Equal to 10% From Week 0percentage of subjects · Week 0, week 56 · number
Lira 3.0 mgn=207Placebon=206
02.9
Percentage of Subjects With Greater Than 50% of Fasting run-in Weight Loss Maintained From Week 0percentage of subjects · Week 0, week 56 · number
Lira 3.0 mgn=207Placebon=206
93.270.9
Percentage of Subjects With Greater Than 75% of Fasting run-in Weight Loss Maintained From Week 0percentage of subjects · Week 0, week 56 · number
Lira 3.0 mgn=207Placebon=206
87.454.4
Change From Baseline in Fasting Weightkg · Week 0, week 56 · least squares mean
Lira 3.0 mgn=194Placebon=188
-5.7(0.66)0.16(0.63)
Change From Baseline in Fasting Weight for Subjects Completing the Main Trial Period and Entering the Follow-up Periodkg · Week 0, week 68 · least squares mean
Lira 3.0 mgn=159Placebon=144
-3.83(0.82)0.41(0.78)
Change From Baseline in Blood PressuremmHg · Week 0, week 56 · least squares mean
MeasureLira 3.0 mgn=207Placebon=206
Change in Systolic Blood Pressure1.31(0.90)4.03(0.87)
Change in Diastolic Blood Pressure1.81(0.64)2.15(0.61)
Change From Baseline in Pulsebeats/minute · Week 0, week 56 · least squares mean
Lira 3.0 mgn=207Placebon=206
4.12(0.68)3.15(0.65)
Change From Baseline in Fasting Lipid Profile: Triglyceridesmmol/L · Week 0, week 56 · least squares mean
Lira 3.0 mgn=194Placebon=187
0.02(0.04)0.12(0.04)
Change From Baseline in Fasting Lipid Profile: Low Density Lipoprotein (LDL) Cholesterolmmol/L · Week 0, week 56 · least squares mean
Lira 3.0 mgn=194Placebon=187
0.24(0.05)0.33(0.05)
Change From Baseline in Fasting Lipid Profile: Total Cholesterolmmol/L · Week 0, week 56 · least squares mean
Lira 3.0 mgn=194Placebon=187
0.22(0.06)0.33(0.06)
The trial

How NCT00781937 was run

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).

  • 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...
  • 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
Who could join the trial

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Published papers

Papers from NCT00781937

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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