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

NCT06754163 | Active Not Recruiting Phase 4

• 1 other identifier: 2024/254
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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."

Conditions

Obesity and Obesity-related Medical Conditions; Psychiatric Disorders

Keywords

semaglutide; wegovy; GLP-1 agonist

Outcome Measures

Primary Outcomes (5)

• Weight

  This will be calculated in kg and the patient weighed on a weekly basis. This will be calculated for the 12 months prior to enrolment into the trial according to the patient's clinical notes and on a weekly basis during the 24 months of the trial.

  36 months

• Body mass index

  The BMI will be calculated according to the ratio of body mass (kg) and height (cm) and will be measured on a weekly basis. This will be calculated for the 12 months prior to enrolment into the trial according to the patient's clinical notes and on a weekly basis during the 24 months of the trial

  36 months

• Waist circumference

  Waist circumference will be measured in cm. This will be calculated for the 12 months prior to enrolment into the trial according to the patient's clinical notes and on a weekly basis during the 24 months of the trial.

  36 months

• Blood pressure

  This will be calculated in mm Hg as both systolic and diastolic blood pressure. This will be calculated for the 12 months prior to enrolment into the trial according to the patient's clinical notes and on a weekly basis during the 24 months of the trial. It will be measured while the patient is in a sitting state.

  36 months

• Heart rate

  This will be calculated as beats per minute and will be measured over a 30 second time period. This will be calculated for the 12 months prior to enrolment into the trial according to the patient's clinical notes and on a weekly basis during the 24 months of the trial.

  36 months

Secondary Outcomes (6)

• To explore the potential relationship between patient adherence to STEP@STAH and changes in quality of life

  24 months

• To explore the potential relationship between patient adherence to STEP@STAH and changes in wellbeing

  24 months

• To explore the potential relationship between patient adherence to STEP@STAH and changes in wellbeing

  24 months

• To explore the potential relationship between patient adherence to STEP@STAH and changes in physical activity

  24 months

• To explore the potential relationship between co-morbidities and impact of STEP@STAH

  24 months

Study Arms (1)

Evaluating the Effect of the STEP Protocol on Physical Health Measures

EXPERIMENTAL

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.

Drug: Semaglutide in combination with a healthy lifestyle intervention (diet and exercise)

Interventions

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

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.

Evaluating the Effect of the STEP Protocol on Physical Health Measures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 at St Andrew's Healthcare
• Sufficient level of English to read and understand the information sheet (may require verbal explanation from support from staff)

You may not qualify if:

• 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

Sponsors & Collaborators

• St Andrew's Healthcare: lead
• Loughborough University: collaborator

Study Sites (1)

St Andrew's Healthcare

Northampton, United Kingdom

Location

MeSH Terms

Conditions

Obesity; Mental Disorders

Interventions

semaglutide; Diet; Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kieran C Breen, PhD

  St Andrew's Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Wegovy is the medication that will be used in the trial. The dosage schedule is available in the summary of product characteristics with a maintenance dose of 2.4 mg or to the maximum tolerated dose. The non-medication component of the intervention will be coordinated by the Occupational Therapy Technical Instructors (OT TIs). Staff will be provided with an information sheet which will emphasise the importance of a multi-disciplinary approach of the 2-year study period. Key points to be highlighted include: * Encourage patients to increase their physical activity * Remind patients to reduce their daily calorie intake * Encourage and support patients to diligently record their physical activity and dietary intake on their Food/Activity/Sleep (FAS) Diary Sheets This coordinated effort aims to support patients effectively and ensure the success of the study through consistent and comprehensive care.

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 31, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The IPD will be available upon completion of he trial for a period of up to three years after publication of the trial results.
• Access Criteria: All requests will be considered by the trial steering group.

Locations

GB (1)