Pilot Study Designed in a Phase IV Clinical Trial Framework: Evaluating the Effect of the STEP@STAH Semaglutide Protocol on the Physical Health Measures of Atypical Antipsychotic-Treated Patients in a Secure Mental Healthcare Setting

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

A significant number of patients who are prescribed anti-psychotic medication such as clozapine are considered as clinically obese (BMI \>35.0). While this may be associated with the appetite promoting properties of the drug, other factors including apathy and lack of physical activity and exercise can exacerbate the weight gain. For those patients who are in a secure care setting and who have restrictions on movement, this provides a particular challenge. Therefore, a pharmacological option to assist in promoting weight loss would be an attractive option for patients who have reached levels of obesity and for whom diet and exercise alone may not be sufficient. The GLP-1 agonist class of drugs, including semaglutide (Wegovy®), have been approved for the treatment of patients as an adjunct to diet and exercise and for weight loss in adults who have a BMI of 30 kg/m² or greater (obese) or weight-related health problems. The aim of this study is to determine whether long-term treatment with Semaglutide (Wegovy®), in combination with dietary advice, exercise and psychological support, will decrease the weight gain associated with anti-psychotic treatment. Patients will be chosen for the trial according to NICE guidelines for referral to a weight management plan. In addition to the weekly Semaglutide (Wegovy®) injection, they will have regular access to dietary and exercise support as part of an overall healthy lifestyle plan which will form part of their overall care plan. They will also be provided with psychological support as a previous trial demonstrated that behavioural support was important, especially at the early stages of such therapy. The patients' progress will be monitored (weight, activity, diet) throughout the duration of the trial. The results will identify those patients who are most likely to benefit from this therapy and can be used to generate treatment guidelines.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• BMI of 35.0 kg/m2 or above or BMI of 32.5 kg/m2 for people from South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family

• Aged 18 or above

• Able to give informed consent, as assessed by their RC. In the context of participation in this trial 'informed' consent includes having an understanding of the dietary and exercises changes needed for the treatment to be effective

• Currently prescribed olanzapine or clozapine

• Currently in an inpatient service

• Sufficient level of English to read and understand the information sheet (may require verbal explanation from support from staff)

Locations
Other Locations
United Kingdom
St Andrew's Healthcare
RECRUITING
Northampton
Contact Information
Primary
Kieran C Breen, PhD
kbreen@stah.org
00447879425837
Backup
Louise Millard
lmillard@stah.org
00441604616080
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 20
Treatments
Experimental: Evaluating the Effect of the STEP Protocol on Physical Health Measures
The primary aim of the study is to assess the impact of treatment with semaglutide, in combination with a healthy lifestyle (including diet and exercise) on the physical health measures of patients in St Andrew's who have atypical antipsychotic induced weight gain. There is significant evidence that atypical antipsychotic drugs (olanzapine and clozapine) can cause patients to put on weight, partly by increasing their appetite. A significant number of people on this class of drugs are considered as overweight or obese. However, no studies have been carried out to determine whether weight loss-associated drugs such as semaglutide, in association with a healthy lifestyle, may be able to overcome this problem. Although semaglutide has been shown to be effective in the general population, this may be more complex in this group of people as it may interact with the anti-psychotic drugs which may prevent it from acting effectively.
Related Therapeutic Areas
Sponsors
Leads: St Andrew's Healthcare
Collaborators: Loughborough University

This content was sourced from clinicaltrials.gov