Clinical trial NCT04781998: Is Saxenda® a Viable Treatment of Obese Patients in Forensic Psychiatry?
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mental Disorder
Metabolic Disturbance
Feasibility
Overweight and Obesity
Liraglutide
Lead sponsor: Psychiatric Centre Rigshospitalet
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An open-label, multi-centre, 26-weeks clinical feasibility study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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®

Primary outcomes:
measure: The primary endpoint is the number of "completers"
timeFrame: 26 weeks
Secondary outcomes:
measure: Reason(s) for drop-out
timeFrame: 26 weeks
measure: Changes in body weight
timeFrame: 26 weeks
measure: HbA1c
timeFrame: 26 weeks
measure: blood pressure
timeFrame: 26 weeks
measure: heart rate
timeFrame: 26 weeks
measure: FIB-4 score
timeFrame: 26 weeks
measure: lipid profile
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Psychiatric Centre Sct.Hans. Forensic Mental Health Services in the Capitol Region of Denmark.
Study officials:
References: