Effect of liraglutide on body weight in obese subjects without diabetes. A 20-week randomised, double-blind, placebo-controlled, six armed parallel group, multi-centre, multinational trial with an open label orlistat comparator arm with an 84 week extension periodTrial Phase:2b

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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 < 7.0 mmol/L

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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