LivingGLP1
Study S000492

Effect of Liraglutide on Body Weight in Non-diabetic Obese Subjects or Overweight Subjects With Co-morbidities: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Trial With Stratification of Subject to Either 56 or 160 Weeks of Treatment Based on Pre-diabetes Status at Randomisation

Included trial: extracted dataClinicalTrials.gov record

Registration

Registration
NCT01272219
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
DOUBLE
Status
COMPLETED
Enrollment
3731
Start
2011-06-01
Primary completion
2013-03-18
Lead sponsor
Novo Nordisk A/S
Conditions
Metabolism and Nutrition Disorder; Obesity
Interventions
DRUG:liraglutide; DRUG:placebo
Results posted
TRUE
Secondary identifiers
EUDRACT_NUMBER:2008-001049-24; OTHER:U1111-1118-7871; NIH:2008

Registered primary outcomes

  • Change From Baseline in Fasting Body Weight [Week 0, Week 56]
  • Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight. [At Week 56]
  • Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight [At 56 weeks]
  • Proportion of Subjects With Onset of Type 2 Diabetes [At 160 weeks]

Linked records (20)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0012116Glucagon-like Peptide-1 Receptor Analogues for the Treatment of Obesity.
Williams DM, TouchREVIEWS in endocrinology
2022Narrative reviewPMID 35975210DOIcites ClinicalTrials.gov:NCT01272219; registry reference DERIVED:35975210
R0013170Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials.
Davies MJ, Diabetes, obesity & metabolism
2018Systematic reviewPMID 28950422DOIregistry reference RESULT:28950422
R0025539Improvements in health-related quality of life over 3 years with liraglutide 3.0 mg compared with placebo in participants with overweight or obesity.
Kolotkin RL, Clinical obesity
2018Other trialPMID 29045079DOIregistry reference RESULT:29045079
R0022210Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials.
O'Neil PM, Diabetes, obesity & metabolism
2017Randomized trialPMID 28386912DOIregistry reference RESULT:28386912
R0025087Comparison 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 C, Obesity facts
2017Randomized trialPMID 29145215DOIregistry reference RESULT:29145215
R00257813 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 CW, Lancet (London, England)
2017Randomized trialPMID 28237263DOIcites ClinicalTrials.gov:NCT01272219; registry reference RESULT:28237263
R0025797Effect of weight reductions on estimated kidney function: Post-hoc analysis of two randomized trials.
von Scholten BJ, Journal of diabetes and its complications
2017Randomized trialPMID 28462892DOIcites ClinicalTrials.gov:NCT01272219; registry reference RESULT:28462892
R0025976Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects.
Bays H, Current medical research and opinion
2017Randomized trialPMID 27817208DOIcites ClinicalTrials.gov:NCT01272219; registry reference RESULT:27817208
R00513973-year efficacy and safety for liraglutide 3.0 mg in adults with obesity/overweight, prediabetes and baseline BMI < 35 vs. ≥35 kg/m2 in the SCALE Obesity and Prediabetes, double-blind, placebo-controlled trial
Matthias Blüher, Diabetologie und Stoffwechsel
2017Randomized trialDOIcites ClinicalTrials.gov:NCT01272219
R0022244Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis.
Overgaard RV, Clinical pharmacokinetics
2016Other trialPMID 27193270DOIregistry reference RESULT:27193270
R0023240Exposure-response analyses of liraglutide 3.0 mg for weight management.
Wilding JP, Diabetes, obesity & metabolism
2016Randomized trialPMID 26833744DOIregistry reference RESULT:26833744
R0026099Improvements in health-related quality of life with liraglutide 3.0 mg compared with placebo in weight management.
Kolotkin RL, Clinical obesity
2016Randomized trialPMID 27198973DOIregistry reference RESULT:27198973
R0026209Early Weight Loss with Liraglutide 3.0 mg Predicts 1-Year Weight Loss and is Associated with Improvements in Clinical Markers.
Fujioka K, Obesity (Silver Spring, Md.)
2016OtherPMID 27804269DOIcites ClinicalTrials.gov:NCT01272219; registry reference RESULT:27804269
R0026243EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS.
O'Neil PM, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists
2016Randomized trialPMID 27482610DOIregistry reference RESULT:27482610
R0026436Efficacy 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 J, Diabetes, obesity & metabolism
2016Randomized trialPMID 26744025DOIregistry reference RESULT:26744025
R0027588Missing data in clinical trials for weight management.
McEvoy BW, Journal of biopharmaceutical statistics
2016Narrative reviewPMID 26418188DOIregistry reference RESULT:26418188
R0022927A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management.
Pi-Sunyer X, The New England journal of medicine
2015Randomized trialPMID 26132939DOIcites ClinicalTrials.gov:NCT01272219; registry reference RESULT:26132939
R0048658Efficacy and safety of liraglutide 3.0 mg for weight management in overweight and obese adults: the SCALE™ Obesity and Prediabetes, a randomised, double-blind and placebo-controlled trial
Matthias Blüher, Experimental and Clinical Endocrinology & Diabetes
2015Randomized trialDOIcites ClinicalTrials.gov:NCT01272219
R0052673Efficacy and safety of liraglutide 3.0 mg in adult overweight and obese weight loss responders without diabetes: results of the randomised, double-blind, placebo-controlled 56-week SCALE Obesity and Prediabetes trial
Patrick J. O’Neil, Diabetologie und Stoffwechsel
2015Randomized trialDOIcites ClinicalTrials.gov:NCT01272219
R0051239Liraglutide Helps Achieve Significant Weight Loss in Overweight or Obese Patients
Brian D. Hoyle, MD Conference Express
2014Randomized trialDOIcites ClinicalTrials.gov:NCT01272219