The effectiveness of pharmacological treatment with the glucagon-like peptide-1 receptor agonist Liraglutide 3mg (Saxenda®) once-daily for weight management in forensic psychiatry

Phase 1

• Conditions: Severe mental illnessObesity; MedDRA version: 20.0Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2020-003718-11-DK
• Lead Sponsor: Mental Health Center Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-30
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified