Back to resultsIs Saxenda® a Viable Treatment of Obese Patients in Forensic Psychiatry?
Primary Purpose
Mental Disorder, Metabolic Disturbance, Feasibility
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
liraglutide 3 mg (Saxenda®) once-daily
Sponsored by
About this trial
This is an interventional treatment trial for Mental Disorder
Eligibility Criteria
Inclusion Criteria:
- Informed oral and written consent
- Diagnosed with a mental illness according to the criteria of ICD10
- Hospitalised at a forensic psychiatric department during the full inclusion period
- Age 18 years to 65 years (both included)
- 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:
- Any use of coercive measures according to the Danish law for Mental Health/Psykiatriloven (as defined in "Informationsbekendtgørelsen § 10").
- Fertile females of child-bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant
- 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
- Impaired hepatic function (plasma liver transaminases >2 times the upper normal limit)
- Impaired renal function (serum creatinine >150 μmol/l and/or macroalbuminuria)
- Impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase >2 times the upper normal limit)
- Cardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris and/or myocardial infarction within the last 12 months
- Hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg
- Any condition that the investigator feels would interfere with trial participation
- Use of weight-lowering pharmacotherapy within the preceding 3 months
- Type 1 diabetes
- Patients treated with insulin
- Patients treated with other GLP-1 receptor agonist medicines
- Known allergy to liraglutide or any of the ingredients in Saxenda®
Sites / Locations
- Psychiatric Centre Sct.Hans. Forensic Mental Health Services in the Capitol Region of Denmark.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
liraglutide 3 mg (Saxenda®) once-daily
Arm Description
Outcomes
Primary Outcome Measures
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%.
Secondary Outcome Measures
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
Changes in body weight
Kg
HbA1c
mmol/mol
blood pressure
mmHg
heart rate
Beats/minute
FIB-4 score
index
lipid profile
mmol/L
Full Information
NCT ID
NCT04781998
First Posted
March 1, 2021
Last Updated
August 7, 2023
Sponsor
Anders Fink-Jensen, MD, DMSci
1. Study Identification
Unique Protocol Identification Number
NCT04781998
Brief Title
Is Saxenda® a Viable Treatment of Obese Patients in Forensic Psychiatry?
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 21, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anders Fink-Jensen, MD, DMSci
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder, Metabolic Disturbance, Feasibility, Overweight and Obesity, Liraglutide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
An open-label, multi-centre, 26-weeks clinical feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
liraglutide 3 mg (Saxenda®) once-daily
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
liraglutide 3 mg (Saxenda®) once-daily
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary endpoint is the number of "completers"
Description
Feasibility in this study is defined as a minimum of 75% completers with a confidence interval of ±10%.
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Reason(s) for drop-out
Description
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
Time Frame
26 weeks
Title
Changes in body weight
Description
Kg
Time Frame
26 weeks
Title
HbA1c
Description
mmol/mol
Time Frame
26 weeks
Title
blood pressure
Description
mmHg
Time Frame
26 weeks
Title
heart rate
Description
Beats/minute
Time Frame
26 weeks
Title
FIB-4 score
Description
index
Time Frame
26 weeks
Title
lipid profile
Description
mmol/L
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed oral and written consent
Diagnosed with a mental illness according to the criteria of ICD10
Hospitalised at a forensic psychiatric department during the full inclusion period
Age 18 years to 65 years (both included)
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:
Any use of coercive measures according to the Danish law for Mental Health/Psykiatriloven (as defined in "Informationsbekendtgørelsen § 10").
Fertile females of child-bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant
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
Impaired hepatic function (plasma liver transaminases >2 times the upper normal limit)
Impaired renal function (serum creatinine >150 μmol/l and/or macroalbuminuria)
Impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase >2 times the upper normal limit)
Cardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris and/or myocardial infarction within the last 12 months
Hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg
Any condition that the investigator feels would interfere with trial participation
Use of weight-lowering pharmacotherapy within the preceding 3 months
Type 1 diabetes
Patients treated with insulin
Patients treated with other GLP-1 receptor agonist medicines
Known allergy to liraglutide or any of the ingredients in Saxenda®
Facility Information:
Facility Name
Psychiatric Centre Sct.Hans. Forensic Mental Health Services in the Capitol Region of Denmark.
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Is Saxenda® a Viable Treatment of Obese Patients in Forensic Psychiatry?
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