obesity MedDRA version: 9.0 Level: PT Classification code 10012601
Conditions
Interventions
Product Name: Liraglutide
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Liraglutide
Current Sponsor code: NN2211
Other descriptive name: NNC90-1170
Concentration unit: mg/ml milligr
Sponsors
Novo Nordisk A/S
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Informed consent obtained prior to any trial-related activities. (Trial-related activities are any procedure that would not have been performed during the normal management of the subject) 2.Body Mass Index (BMI) = 30.0 and = 40.0 kg/m2 3.Stable body weight (less than 5% self-reported change during the previous 3 months) 4.Age between 18 and 65 years (both inclusive) 5.Fasting plasma glucose =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Untreated thyroid disease defined as TSH values outside normal ranges or obesity induced by other known endocrinological disorders 2.Obesity induced by drug treatment (e.g. corticosteroids, tricyclic anti-depressants, atypical anti-psychotics) 3.Use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramin, rimonabant) within the last 3 months prior to screening into this trial 4.Participation in a clinical study of weight control within the last 3 months prior to screening into this trial 5.Previous surgical treatment of obesity 6.Subjects with chronic malabsorption syndrome or cholestasis 7.Known type 1 or type 2 diabetes 8.Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the Investigator 9.Impaired liver function, defined as ALAT = 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive) 10.Impaired renal function defined as serum-creatinine = 135 µmol/L (= 1.5 mg/dL) for males and = 120 µmol/L (= 1.4 mg/dL) for females (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive) 11.Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (NYHA class III and IV) at the discretion of the Investigator. (Please refer to Appendix C) 12.Uncontrolled treated/untreated hypertension (systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg) 13.Any clinically significant disease which in the Investigator’s opinion could interfere with the results of the trial 14.Cancer (past or present, except basal cell skin cancer or sqaumous cell skin cancer), which in the Investigator’s opinion could interfere with the results of the trial 15.Known or suspected allergy to trial product(s) or related product(s) 16.Previous participation in this trial (screening and treatment period) 17.Known or suspected abuse of alcohol or narcotics 18.Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation 19.Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) 20.The receipt of any investigational drug within four weeks prior to screening into this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of liraglutide to induce weight loss;Secondary Objective: •To establish the dose-response relationship of four dose levels of liraglutide and placebo on weight loss •To compare the weight lowering effect of liraglutide to orlistat To investigate the effect induced by liraglutide on: •Body composition •Cardiovascular risk factors •Glucose metabolism incl. ß-cell function •Presence of the metabolic syndrome •Patient reported quality of life ;Primary end point(s): Body weight loss | — |
Countries
Czech Republic, Denmark, Finland, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed