EUCTR2020-003718-11-DKActive, not recruitingPhase 1
The effectiveness of pharmacological treatment with the glucagon-like peptide-1 receptor agonist Liraglutide 3mg (Saxenda®) once-daily for weight management in forensic psychiatry; An Exploratory pilot study.
Mental Health Center Copenhagen0 sites40 target enrollmentStarted: August 30, 2020Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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