Is Saxenda® a Viable Treatment of Obese Patients in Forensic Psychiatry?

Phase 4

Completed

• Conditions: Mental Disorder; Overweight and Obesity; Metabolic Disturbance; Feasibility; Liraglutide
• Interventions: Drug: liraglutide 3 mg (Saxenda®) once-daily

• Registration Number: NCT04781998
• Lead Sponsor: Anders Fink-Jensen, MD, DMSci

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-04
• Study Start: 2021-07-01
• Primary Completion: 2022-07-21
• Study Completion: 2022-09-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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®

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
liraglutide 3 mg (Saxenda®) once-daily	liraglutide 3 mg (Saxenda®) once-daily	-

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the number of "completers"	26 weeks	Feasibility in this study is defined as a minimum of 75% completers with a confidence interval of ±10%.

Secondary Outcome Measures

Name	Time	Method
Changes in body weight	26 weeks	Kg
Reason(s) for drop-out	26 weeks	The reason for withdrawal may be the withdrawal of consent, any use of coercive measures, failure to maintain a present level of compliance with the clinical trial medication
HbA1c	26 weeks	mmol/mol
blood pressure	26 weeks	mmHg
heart rate	26 weeks	Beats/minute
FIB-4 score	26 weeks	index
lipid profile	26 weeks	mmol/L

Trial Locations

Locations (1)

Psychiatric Centre Sct.Hans. Forensic Mental Health Services in the Capitol Region of Denmark.; 🇩🇰 Roskilde, Denmark