Evaluation of the feasibility and acceptability of liraglutide 3.0mg as a management of overweight and obesity in people with severe mental illness (LOSE Weight trial)

Abstract

Background
People with severe mental illness (SMI) are 2-3 times more likely to be overweight and obese than the general population and this is associated with significant morbidity and premature mortality. This study investigated the feasibility and acceptability of using daily injections of liraglutide 3.0 mg to address this problem.
Methods
Design: Double-blind, randomised, placebo-controlled pilot trial.
Setting: Mental health centres and primary care within Southern Health NHS Foundation Trust.
Participants: Adults with schizophrenia, schizoaffective, or first episode psychosis prescribed antipsychotic medication who were overweight or obese.
Intervention: Participants were allocated to either once daily subcutaneous liraglutide or placebo, titrated to 3.0 mg daily, for 6 months.
Primary outcome: recruitment, consent, retention, adherence and acceptability.
Secondary exploratory outcomes: weight, HbA1c and Brief Psychiatric Rating Scale.
Results
799 individuals were screened for eligibility. The commonest reasons for exclusion were ineligibility (44%) and inability to make contact (28%). The acceptance rate, as a proportion of all eligible participants, was 12.2%. The main reason why eligible candidates declined to participate related to the study specific medication and protocol (n= 50). 47 participants were randomised with 79% completing the trial. Participants in the liraglutide arm had lost a mean 5.7±7.9 kg compared with no significant weight change in the placebo group (treatment difference −6.0 kg, p=0.015). BMI, waist circumference and HbA1c reduced in the intervention group. The intervention was acceptable to the trial participants.
Conclusions
A pilot study has been undertaken in people with in people with SMI looking at the use of liraglutide (maximum dose 3.0 mg daily) which appeared to be acceptable, safe and effective without adversely affecting the mental health status of the participants This study supports the need for a larger randomised controlled trial to evaluate use of liraglutide (maximum dose 3.0 mg daily) in the management of obesity in people with SMI.

More information

Identifiers

ORCID for Richard Holt: orcid.org/0000-0001-8911-6744

Catalogue record

Export record