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Completed

NCT Number: NCT04781998

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Roskilde, 4000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

liraglutide 3 mg (Saxenda®) once-daily

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.

Primary outcomes

  1. 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%.

Secondary outcomes

  1. Reason(s) for drop-out

    Time frame: 26 weeks

    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

  2. Changes in body weight

    Time frame: 26 weeks

    Kg

  3. HbA1c

    Time frame: 26 weeks

    mmol/mol

  4. blood pressure

    Time frame: 26 weeks

    mmHg

  5. heart rate

    Time frame: 26 weeks

    Beats/minute

  6. FIB-4 score

    Time frame: 26 weeks

    index

  7. lipid profile

    Time frame: 26 weeks

    mmol/L

Sponsors and collaborators

Lead sponsor

Anders Fink-Jensen, MD, DMSci

Other

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 4, 2021
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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