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Is Saxenda® a Viable Treatment of Obese Patients in Forensic Psychiatry?
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.
Lead sponsor
Asset
Liraglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
24
actual
Study population
Obesity / overweight, Psychiatric (schizophrenia / bipolar / depression)
Key I/E criterion
•BMI ≥27
Primary endpoint
•Primary endpoint is the number of "completers"
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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®
Endpoints (8)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointChanges in body weight
Time frame:26 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
1 endpointHbA1c
Time frame:26 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
MASH / liver
1 endpointFIB-4 score
Time frame:26 weeks
change from baseline, improvement
Cardiometabolic biomarkers
3 endpointsblood pressure
Time frame:26 weeks
change from baseline, improvement
heart rate
Time frame:26 weeks
Heart rate, change
change from baseline, improvement
lipid profile
Time frame:26 weeks
change from baseline, improvement
Safety / tolerability / PK
2 endpointsThe primary endpoint is the number of "completers"
Time frame:26 weeks
descriptive
Reason(s) for drop-out
Time frame:26 weeks
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.