Is Saxenda® a Viable Treatment of Obese Patients in Forensic Psychiatry?

Study Overview
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Brief Summary
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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.

Official Title
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Is Pharmacological Treatment With the Glucagon-like Peptide-1 Receptor Agonist Liraglutide 3mg (Saxenda®) Once-daily a Viable Treatment for Weight Management in Forensic Psychiatry Patients? A Feasibility Study.

Conditions
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Mental Disorder, Metabolic Disturbance, Feasibility, Overweight and Obesity, Liraglutide

Intervention / Treatment
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* Drug: liraglutide 3 mg (Saxenda®) once-daily


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed oral and written consent Diagnosed with a mental illness according to the criteria of ICD10 Hospitalised at a forensic psychiatric department during the full inclusion period Age 18 years to 65 years (both included) 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: Any use of coercive measures according to the Danish law for Mental Health/Psykiatriloven (as defined in Informationsbekendtgørelsen § 10). Fertile females of child-bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant 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 Impaired hepatic function (plasma liver transaminases >2 times the upper normal limit) Impaired renal function (serum creatinine >150 μmol/l and/or macroalbuminuria) Impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase >2 times the upper normal limit) Cardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris and/or myocardial infarction within the last 12 months Hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg Any condition that the investigator feels would interfere with trial participation Use of weight-lowering pharmacotherapy within the preceding 3 months Type 1 diabetes Patients treated with insulin Patients treated with other GLP-1 receptor agonist medicines Known allergy to liraglutide or any of the ingredients in Saxenda®

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: An open-label, multi-centre, 26-weeks clinical feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: liraglutide 3 mg (Saxenda®) once-daily<br> | Drug: liraglutide 3 mg (Saxenda®) once-daily<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%. | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 26 weeks | 
| Changes in body weight | Kg | 26 weeks | 
| HbA1c | mmol/mol | 26 weeks | 
| blood pressure | mmHg | 26 weeks | 
| heart rate | Beats/minute | 26 weeks | 
| FIB-4 score | index | 26 weeks | 
| lipid profile | mmol/L | 26 weeks |