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

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide.

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.

The researchers wish to determine the viability of the daily Saxenda®-injection treatment in this specific patient group.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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).

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: 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; impaired hepatic function (plasma liver transaminases \>2 times the upper normal limit).

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Liraglutide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2021-07-01 with completion listed for 2022-07-21.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The primary endpoint is the number of "completers" (time frame: 26 weeks).

It also tracked 7 secondary outcomes, for example Reason(s) for drop-out, Changes in body weight, HbA1c, blood pressure, heart rate and FIB-4 score.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Liraglutide in 24 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.