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CompletedPhase 4

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.

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

NCT IDNCT04781998
Org study IDSaxPsychiatry

Timeline

Milestones

Study first posted2021-03-04actual
Study start2021-07-01actual
Primary completion2022-07-21actual
Study completion2022-09-01actual
Last update posted2023-08-08actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightPsychiatric (schizophrenia / bipolar / depression)

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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

Cardiometabolic biomarkers
3
Safety / tolerability / PK
2
Weight & body composition
1
Glycemic / diabetes
1
MASH / liver
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Changes in body weight

Time frame:26 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

HbA1c

Time frame:26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

1 endpoint
Secondary/protocol endpoint

FIB-4 score

Time frame:26 weeks

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

blood pressure

Time frame:26 weeks

change from baseline, improvement

Secondary/protocol endpoint

heart rate

Time frame:26 weeks

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

lipid profile

Time frame:26 weeks

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

The primary endpoint is the number of "completers"

Time frame:26 weeks

descriptive

Secondary/protocol endpoint

Reason(s) for drop-out

Time frame:26 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.