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

NCT ID: NCT04781998

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-09-01

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.

Conditions

Mental Disorder; Metabolic Disturbance; Feasibility; Overweight and Obesity; Liraglutide

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

liraglutide 3 mg (Saxenda®) once-daily

Group Type: EXPERIMENTAL

liraglutide 3 mg (Saxenda®) once-daily

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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®

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anders Fink-Jensen, MD, DMSci

OTHER

Sponsor Role: lead

Responsible Party

Anders Fink-Jensen, MD, DMSci

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Psychiatric Centre Sct.Hans. Forensic Mental Health Services in the Capitol Region of Denmark.

Roskilde, , Denmark

Countries

Denmark

Other Identifiers

SaxPsychiatry

Identifier Type: -

Identifier Source: org_study_id