RecruitingPhase 4NCT06754163

Evaluating the Effect of the STEP@STAH Semaglutide Protocol on the Physical Health Measures of Atypical Antipsychotic-Treated Patients

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


Sponsor

St Andrew's Healthcare

Enrollment

20 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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)

Exclusion Criteria6

  • Aged 17 or under
  • Meet any of the contraindications, including hypersensitivity to the active substance or to any of the excipients
  • Pregnant or likely to become pregnant
  • Diagnoses of dementia or Huntington's disease
  • On a PICU/acute ward
  • Discharge anticipated to be in 6 months' time or less

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Interventions

DRUGSemaglutide in combination with a healthy lifestyle intervention (diet and exercise)

Wegovy (semaglutide) will be provided as an induction dose of 0.25 mg, titrated up every 4 weeks to 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg, will be given, with a maintenance dose of 2.4 mg or to the maximum tolerated dose. To reduce the likelihood of gastrointestinal symptoms, the dose should be escalated over a 16-week period to a maintenance dose of 2.4 mg once weekly. The semaglutide injection will be administered once weekly on the same day of the week throughout the study period. Injections will be administered in the thigh, abdomen or upper arm at any time of the day. As part of the multi-disciplinary approach taken in the STEP trials of Wegovy, patients willl be encouraged to * Increase their physical activity * Reduce their daily calorie intake * Record their physical activity and dietary intake on their Food/Activity/Sleep (FAS) Diary Sheets A secondary goal is to achieve sustained improvements in participants' activity levels and awareness of a healthy diet.


Locations(1)

St Andrew's Healthcare

Northampton, United Kingdom

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NCT06754163


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