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

NCT04781998 | Completed Phase 4 DMC

• 1 other identifier: SaxPsychiatry
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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%.

  26 weeks

Secondary Outcomes (7)

• Reason(s) for drop-out

  26 weeks

• Changes in body weight

  26 weeks

• HbA1c

  26 weeks

• blood pressure

  26 weeks

• heart rate

  26 weeks

Study Arms (1)

liraglutide 3 mg (Saxenda®) once-daily

EXPERIMENTAL

Drug: liraglutide 3 mg (Saxenda®) once-daily

Interventions

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.

liraglutide 3 mg (Saxenda®) once-daily

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed oral and written consent
• Diagnosed with a mental illness according to the criteria of ICD10
• 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

You may not qualify if:

• 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®

Sponsors & Collaborators

• Anders Fink-Jensen, MD, DMSci: lead

Study Sites (1)

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

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Mental Disorders; Overweight; Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: An open-label, multi-centre, 26-weeks clinical feasibility study

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: July 1, 2021
• Primary Completion: July 21, 2022
• Study Completion: September 1, 2022
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)