Mental DisorderPhase 4NCT04781998
Is Saxenda® a Viable Treatment of Obese Patients in Forensic Psychiatry?
A Phase 4 study testing liraglutide 3 mg (Saxenda®) once-daily in people with Mental Disorder and Metabolic Disturbance, run by Anders Fink-Jensen, MD, DMSci at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Disorder, Metabolic Disturbance, Feasibility
- What is being tested?
- liraglutide 3 mg (Saxenda®) once-daily
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2021to 1 Sep 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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®
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Psychiatric Centre Sct.Hans. Forensic Mental Health Services in the Capitol Region of Denmark.
Roskilde, 4000
About this study
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.
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.
- Being tested
- liraglutide 3 mg (Saxenda®) once-daily
- Medical subject headings
- Mental Disorders, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutide 3 mg (Saxenda®) once-dailyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| liraglutide 3 mg (Saxenda®) once-daily | Experimental | Not described Receives: Drug: liraglutide 3 mg (Saxenda®) once-daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 26 weeks
Secondary outcomes (7)
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
Measured: 26 weeks
Changes in body weight
Kg
Measured: 26 weeks
HbA1c
mmol/mol
Measured: 26 weeks
blood pressure
mmHg
Measured: 26 weeks
heart rate
Beats/minute
Measured: 26 weeks
FIB-4 score
index
Measured: 26 weeks
lipid profile
mmol/L
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Jul 2021
- Primary completion21 Jul 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An open-label, multi-centre, 26-weeks clinical feasibility study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anders Fink-Jensen, MD, DMSci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anders Fink-Jensen, MD, DMSci, Psychiatric Centre Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781998
- Sponsor's protocol ID
- SaxPsychiatry
- Status last verified
- Aug 2023
- First submitted
- 1 Mar 2021
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04781998
- Acronym / sponsor ID
- SaxPsychiatry
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Anders Fink-Jensen, MD, DMSciUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open-label, multi-centre, 26-weeks clinical feasibility study
| Arm | Type | Receives |
|---|---|---|
| liraglutide 3 mg (Saxenda®) once-daily | Experimental | Drug: liraglutide 3 mg (Saxenda®) once-daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liraglutide 3 mg (Saxenda®) once-dailyLiraglutide 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. | Drug | liraglutide 3 mg (Saxenda®) once-daily |
Primary outcome
The primary endpoint is the number of "completers"
Time frame: 26 weeks
Feasibility in this study is defined as a minimum of 75% completers with a confidence interval of ±10%.
7 secondary outcomes
Reason(s) for drop-out
Time frame: 26 weeks
Changes in body weight
Time frame: 26 weeks
HbA1c
Time frame: 26 weeks
blood pressure
Time frame: 26 weeks
heart rate
Time frame: 26 weeks
FIB-4 score
Time frame: 26 weeks
lipid profile
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing liraglutide 3 mg (Saxenda®) once-daily in people with Mental Disorder and Metabolic Disturbance, run by Anders Fink-Jensen, MD, DMSci at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the number of "completers" (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.