L.O.S.E Weight Version 1.0
Research type
Research Study
Full title
Liraglutide and the management of overweight and obesity in people with schizophrenia: a pilot study
IRAS ID
235189
Contact name
Richard Holt
Contact email
Sponsor organisation
Southern Health NHS Foundation Trust
Eudract number
2017-004064-35
Clinicaltrials.gov Identifier
U1111-1203-0068 , UTN
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
People with schizophrenia die 10- 20 years earlier than the general population. This is in part due to the fact that they are two times more likely to be overweight. Lifestyle interventions have not been shown to be effective for this population in NHS settings. The drug liraglutide is similar to a hormone (glucagon-like peptide 1) which suppresses appetite. It has recently been licensed at a high dose (3 mg) as a once daily injectable therapy for overweight and obesity.
We will invite people with schizophrenia, schizoaffective disorder or first episode psychosis (age >18 years) from community and inpatient mental health settings in Southern Health NHS Foundation Trust. To be eligible for the trial participants must have been on antipsychotic medication for a minimum of one month and be either obese (body mass index (BMI) >30 kg/m²) or be overweight (BMI ≥ 27 kg/m² to < 30 kg/m²) and have at least one weight related comorbidity. Eligible participants will be randomised to either liraglutide 3mg each day or placebo once confirmed that they can take part in the trial after their screening visit.
The study will then consist a 26 week treatment period. Up-titration of the medication will be over 4 weeks done over the phone or in person. Study data will be collected at baseline, 12 and 26 weeks.
The main aim of the study is to gather data on recruitment, consent, retention, adherence and dropout rates. Qualitative interviews with a sub-sample of invention-arm participants and healthcare workers will provide data on the practicality and acceptability of liraglutide. Clinical outcome measures will include weight (kilogram) change at 26 weeks and the number that therefore maintained or reduced weight. If an effect size is seen this would be used to calculate the number of participants needed to power a definitive trial.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
18/SC/0085
Date of REC Opinion
17 Apr 2018
REC opinion
Further Information Favourable Opinion