An open-label, multi-centre, 26-weeks clinical feasibility study. The objective is to explore whether Saxenda could be a feasible choice in the treatment of overweight, obesity and weight-related medical problems, in patients diagnosed with a severe mental illness and hospitalized at a forensic department in Denmark. We wish to determine the viability of the daily Saxenda®-injection treatment in this specific patient group.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Liraglutide 3 mg (Saxenda®) 6 mg/ml, 3 ml pre-filled pen-injector. The injection is administered subcutaneously. The initial daily dose will be 0.6 mg liraglutide (Saxenda®) for one week. If tolerated patients increase the dose by +0.6 mg each week until the full maintenance of 3 mg is reached (week 1: 0.6 mg, week 2: 1.2 mg, week 3: 1.8 mg, week 4: 2.4 mg, week 5-26: 3.0 mg. If necessary, a longer titration period is accepted). If the lowest tolerated dose is less than 1.8 mg of liraglutide (Saxenda®) once-daily after 12 weeks from inclusion, the patient will be excluded from the study.
Psychiatric Centre Sct.Hans. Forensic Mental Health Services in the Capitol Region of Denmark.
Roskilde, Denmark
The primary endpoint is the number of "completers"
Feasibility in this study is defined as a minimum of 75% completers with a confidence interval of ±10%.
Time frame: 26 weeks
Reason(s) for drop-out
The reason for withdrawal may be the withdrawal of consent, any use of coercive measures, failure to maintain a present level of compliance with the clinical trial medication
Time frame: 26 weeks
Changes in body weight
Kg
Time frame: 26 weeks
HbA1c
mmol/mol
Time frame: 26 weeks
blood pressure
mmHg
Time frame: 26 weeks
heart rate
Beats/minute
Time frame: 26 weeks
FIB-4 score
index
Time frame: 26 weeks
lipid profile
mmol/L
Time frame: 26 weeks
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