E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Severe mental illness Obesity |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10037175 |
E.1.2 | Term | Psychiatric disorders |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this study is to investigate the effectiveness of pharmacological treatment with liraglutide 3 mg (Saxenda®) for bodyweight management in patients with diagnosed with severe mental illness and excess weight (BMI ≥27 kg/m2) who also have bodyweight related medical problems or with severe mental illness and obesity (BMI ≥30 kg/m2), admitted to a forensic psychiatry department. The primary endpoint is the number of patients completing the study defined as “completers”. |
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints include reason(s) for drop out, changes in body weight, glycated haemoglobin A1c (HbA1c), blood pressure, heart rate, fibrosis-4 (FIB-4) score and lipid profile. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Informed oral and written consent 2. Diagnosed with a mental illness 3. Hospitalised at a forensic psychiatric department 4. Age 18 years to 65 years (both included) 5. BMI ≥27 kg/m2 with one or more weight-related comorbidities (hypertension, dyslipidaemia, pre-diabetes or type 2 diabetes) or BMI ≥30 kg/m2
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E.4 | Principal 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 adequate contraceptive 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the number of “completers”. A “completer” is defined as a patient maintaining a present level of compliance with the clinical trial medication and completing full study duration (26 weeks). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary endpoints include reason(s) for drop-out, changes in body weight, HbA1c, blood pressure, heart rate, FIB-4 score, and lipid profile. For patients enrolled in the study, all endpoints will initially be collected and several repeated during the full study duration. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |