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

Overweight and Obesity Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04781998
• Other study ID #: SaxPsychiatry
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: August 2023
• Source: Psychiatric Centre Rigshospitalet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 1, 2022
• Est. primary completion date: July 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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®

Related Conditions & MeSH terms

• Feasibility
• Liraglutide
• Mental Disorder
• Mental Disorders
• Metabolic Disturbance
• Overweight
• Overweight and Obesity

Intervention

Drug:
• liraglutide 3 mg (Saxenda®) once-daily
Liraglutide 3 mg (Saxenda®) 6 mg/ml, 3 ml pre-filled pen-injector. The injection is administered subcutaneously. The initial daily dose will be 0.6 mg liraglutide (Saxenda®) for one week. If tolerated patients increase the dose by +0.6 mg each week until the full maintenance of 3 mg is reached (week 1: 0.6 mg, week 2: 1.2 mg, week 3: 1.8 mg, week 4: 2.4 mg, week 5-26: 3.0 mg. If necessary, a longer titration period is accepted). If the lowest tolerated dose is less than 1.8 mg of liraglutide (Saxenda®) once-daily after 12 weeks from inclusion, the patient will be excluded from the study.

Locations

Country	Name	City	State
Denmark	Psychiatric Centre Sct.Hans. Forensic Mental Health Services in the Capitol Region of Denmark.	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Anders Fink-Jensen, MD, DMSci

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the number of "completers"	Feasibility in this study is defined as a minimum of 75% completers with a confidence interval of ±10%.	26 weeks
Secondary	Reason(s) for drop-out	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	26 weeks
Secondary	Changes in body weight	Kg	26 weeks
Secondary	HbA1c	mmol/mol	26 weeks
Secondary	blood pressure	mmHg	26 weeks
Secondary	heart rate	Beats/minute	26 weeks
Secondary	FIB-4 score	index	26 weeks
Secondary	lipid profile	mmol/L	26 weeks