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.

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Roskilde, Denmark, 4000
    • Psychiatric Centre Sct.Hans. Forensic Mental Health Services in the Capitol Region of Denmark.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: liraglutide 3 mg (Saxenda®) once-daily

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Changes in body weight	Kg	26 weeks
HbA1c	mmol/mol	26 weeks
blood pressure	mmHg	26 weeks
heart rate	Beats/minute	26 weeks
FIB-4 score	index	26 weeks
lipid profile	mmol/L	26 weeks

Collaborators and Investigators

• Sponsor: Anders Fink-Jensen, MD, DMSci

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): July 21, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: March 1, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Mental Disorders; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: SaxPsychiatry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No