EUCTR2006-004481-13-SEActive, not recruitingNot Applicable
Effect of liraglutide on body weight in obese subjects without diabetesA 20-week randomised, double-blind, placebo-controlled, six armed parallel group, multi-centre, multinational trial with an open label orlistat comparator armTrial Phase:2b
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ovo Nordisk A/S
- Enrollment
- 547
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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