Feasibility, Liraglutide, Mental Disorder, Metabolic Disturbance, Overweight and Obesity
Conditions
Brief summary
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.
Interventions
DRUGliraglutide 3 mg (Saxenda®) once-daily
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.
Sponsors
Anders Fink-Jensen, MD, DMSci
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
An open-label, multi-centre, 26-weeks clinical feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Informed oral and written consent 2. Diagnosed with a mental illness according to the criteria of ICD10 3. Hospitalised at a forensic psychiatric department during the full inclusion period 4. Age 18 years to 65 years (both included) 5. BMI ≥27 kg/m2 with one or more weight-related comorbidities (sleep apnea, hypertension (BT ≥ 140/90 mmHg with no antihypertensive treatment. BT ≥ 130/80 mmHg with antihypertensive treatment), dyslipidaemia (LDL cholesterol ≥ 3 mmol/L), pre-diabetes (HbA1c 39-47 mmol/mol) or type 2 diabetes (HbA1c ≥ 48 mmol/mol)) or BMI ≥30 kg/m2
Exclusion criteria
1. Any use of coercive measures according to the Danish law for Mental Health/Psykiatriloven (as defined in Informationsbekendtgørelsen § 10). 2. Fertile females of child-bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant 3. Women who are not willing to use an adequate contraceptive considered as highly effective (IUD or hormonal contraception during the full length of the study 4. Impaired hepatic function (plasma liver transaminases \>2 times the upper normal limit) 5. Impaired renal function (serum creatinine \>150 μmol/l and/or macroalbuminuria) 6. Impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase \>2 times the upper normal limit) 7. Cardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris and/or myocardial infarction within the last 12 months 8. Hypertension with systolic blood pressure \>180 mmHg or diastolic blood pressure \>100 mmHg 9. Any condition that the investigator feels would interfere with trial participation 10. Use of weight-lowering pharmacotherapy within the preceding 3 months 11. Type 1 diabetes 12. Patients treated with insulin 13. Patients treated with other GLP-1 receptor agonist medicines 14. Known allergy to liraglutide or any of the ingredients in Saxenda®
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint is the number of completers | 26 weeks | Feasibility in this study is defined as a minimum of 75% completers with a confidence interval of ±10%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in body weight | 26 weeks | Kg |
| HbA1c | 26 weeks | mmol/mol |
| blood pressure | 26 weeks | mmHg |
| Reason(s) for drop-out | 26 weeks | 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 |
| FIB-4 score | 26 weeks | index |
| lipid profile | 26 weeks | mmol/L |
| heart rate | 26 weeks | Beats/minute |
Countries
Denmark
Outcome results
None listed