Is Saxenda® a Viable Treatment of Obese Patients in Forensic Psychiatry? (NCT04781998) | Clinical Trial Compass
CompletedPhase 4
Is Saxenda® a Viable Treatment of Obese Patients in Forensic Psychiatry?
Denmark24 participantsStarted 2021-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary endpoint is the number of "completers"
. 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