Obesity and Obesity-related Medical ConditionsPhase 4STEP@STAHNCT06754163
Evaluating the Effect of the STEP@STAH Semaglutide Protocol on the Physical Health Measures of Atypical Antipsychotic-Treated Patients
A Phase 4 study testing Semaglutide in combination with a healthy lifestyle intervention (diet and exercise) in people with Obesity and Obesity-related Medical Conditions and Psychiatric Disorders, run by St Andrew's Healthcare at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions, Psychiatric Disorders
- What is being tested?
- Semaglutide in combination with a healthy lifestyle intervention (diet and exercise)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2025to 30 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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."
Read the detailed description
The purpose of the study is to determine whether patients who have gained weight due to being prescribed anti- psychotic drugs (olanzapine or clozapine) and have become clinically obese (BMI>35.0) will react to the GLP-1 agonist class of drugs, including semaglutide (Wegovy®), which have been authorised for the treatment of patients as an adjunct to diet and exercise and for weight loss. These have been demonstrated to be effective in adults who are obese due to general overeating and lack of exercise (general lifestyle factors). However, there have been no studies carried out on patients who have had drug-induced weight gain where the drugs have had their impact, at least in part, by altering the body's metabolism. However, weight gain for patients who are treated with anti-psychotic medication is a complex issue as it cannot be solely ascribed to the drugs, as these people tend to be less active and by default to be more immobile. Therefore, the aim of this study is to determine whether GLP-1 agonists (and specifically semaglutide), in combination with dietary and exercise advice (the "NEW You" healthy lifestyle programme) will have a similar impact to those who are obese due to an unhealthy lifestyle which is not drug-induced. Patients are acutely aware of the impact of anti-psychotic medication on their weight and have discussed options with their clinicians.
However, they realise that exercise alone is not sufficient, and that certain drugs increase appetite. Therefore, informal discussions have led to a discussion on the potential use of medication which may assist in weight loss in conjunction with an overall healthy lifestyle (diet and exercise). This was part of the impetus to develop the trial initially at St Andrew's. However, in order to ensure that the evidence generated was robust, it was decided that it should be in the form of a phase 4 observational trial with specific outcome measures. As it would not be feasible to have a placebo control group, it will be in the form of a pre-post analysis.
Recruitment:
Patients who are eligible to enrol in the trial will be identified by their responsible clinician. They will then be approached by a member of the research team who will explain the trial, what it involves and the potential benefits. In particular, they will be made aware that the programme is not just a drug trial but will also involve engagement in a healthy lifestyle programme where the participants will be encouraged to become aware of their diet and also to engage in exercise. Expert members of the multidisciplinary team will provide support throughout the trial and the participants will be made aware of this through the research team. The trial will also be an integral part of their care plan.
Consent:
Patients should be deemed by their responsible clinician as being capable of giving consent to participate in the study and to engage in the interventions such as keeping a food, exercise and sleep diary with the assistance of a staff member.
Risks, burdens and benefits:
As Wegovy is a routinely available drug that will be prescribed under NICE guidelines with patients and staff being made aware of the potential side effects, the risks will be minimal. Full information about the trial will be available in the patient information sheet and support information will be available in the NEW You healthy lifestyle programme documentation which was developed at St Andrew's in 2020 as part of an NHS Commissioning and Quality Innovation (CQUIN) Framework with significant patient input. Participation in the study should result in an overall healthier lifestyle with a greater awareness of diet and exercise, with support from staff and an improved physical health. Participants will be encouraged to monitor their food, activity and sleep (FAS diary), which will increase their awareness of a healthy lifestyle and the benefits thereof. The majority of outcome measures will be routine measures (BMI, blood pressure) and there will be three additional questionnaires administered every three months, each taking approximately ten minutes. The patients will also undergo questionnaires to assess their attitude towards the study (qualitative research) prior to the start of the study, at 12 months and upon completion of the study. This will be should take up to 15 minutes. These will be carried out at the patient's own convenience. Additionally, the patient will be asked to wear an activity monitor (in the form of a watch) for one week every three months. This has been used in previous exercise- based studies at St Andrew's and they have been shown to be well tolerated and the patients are interested to understand the amount of activity that they undergo on a daily basis. .
Confidentiality:
All of the data collected during the study will stored in a password-protected file on the St Andrew's server and only available to names members of the research team. This is highlighted in the patient information sheet.
- Being tested
- Semaglutide in combination with a healthy lifestyle intervention (diet and exercise)
- Keywords
- semaglutide, wegovy, GLP-1 agonist
- Medical subject headings
- Obesity, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Semaglutide in combination with a healthy lifestyle intervention (diet and exercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 36 months
Secondary outcomes (6)
To explore the potential relationship between patient adherence to STEP@STAH and changes in quality of life
Variables will be assessed to understand the mechanism by which the therapy has influenced the patient's overall lifestyle and contributed to changes in their physical health. Specifically, we aim to determine whether the STEP@STAH therapy has affected their:
- Quality of life
To do this, the following additional outcome measures will be collected and correlated with the physical outcomes:
- IWQOL Lite CT Health Survey This will be measured at baseline and then every three months over the course of the trial
Measured: 24 months
To explore the potential relationship between patient adherence to STEP@STAH and changes in wellbeing
Variables will be assessed to understand the mechanism by which the therapy has influenced the patient's overall lifestyle and contributed to changes in their physical health. Specifically, we aim to determine whether the STEP@STAH therapy has affected their:
- Appetite
To do this, the following additional outcome measures will be collected and correlated with the physical outcomes:
- Control of Eating Questionnaire (CoEQ) This will be measured at baseline and at weeks 8, 16, 28 \& 56, 78, 104.
Measured: 24 months
To explore the potential relationship between patient adherence to STEP@STAH and changes in wellbeing
Variables will be assessed to understand the mechanism by which the therapy has influenced the patient's overall lifestyle and contributed to changes in their physical health. Specifically, we aim to determine whether the STEP@STAH therapy has affected their:
- Appetite
To do this, the following additional outcome measures will be collected and correlated with the physical outcomes:
- Leeds Food Preference Questionnaire (LFPQ) This will be measured at baseline and then every six months thereafter.
Measured: 24 months
To explore the potential relationship between patient adherence to STEP@STAH and changes in physical activity
Variables will be assessed to understand the mechanism by which the therapy has influenced the patient's overall lifestyle and contributed to changes in their physical health. Specifically, we aim to determine whether the STEP@STAH therapy has affected their level of physical activity \& exercise. Patients will wear an ActiGraph activity monitor to measure their physical activity (step count) for 1 week every quarter starting 3 months after enrolment.
Measured: 24 months
To explore the potential relationship between co-morbidities and impact of STEP@STAH
All patients will be monitored for physical health problems, particularly type 2 diabetes for which semaglutide has been prescribed. Their medical history will be assessed upon completion of the study to determine whether any incidents of note, such as the development of critical physical health incidents, has occurred and whether these could be attributed to their participation in the current trial
Measured: 24 months
To qualitatively explore the barriers, facilitators and acceptability of the intervention from both patient and staff perspectives
Transcripts will be coded using thematic analysis methods. Initial codes will be generated from the transcripts to capture meaningful units of data related to barriers, facilitators, and acceptability. Codes will be organised into broader themes and sub-themes through iterative review and comparison. Themes will represent patterns and recurring topics across the data. Themes will be interpreted in relation to the research questions, aiming to provide insights into factors influencing the intervention's implementation and acceptance among patients and staff
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start1 Jan 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Andrew's Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- Loughborough University
- Responsible party
- Sponsor
- Investigators
- Kieran C Breen, PhD, Principal investigator, St Andrew's Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754163
- Sponsor's protocol ID
- 2024/254
- Acronym
- STEP@STAH
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised physical healthcare data on clinical outcomes will be available upon request upon completion of the study
Publications
Brenisin K, Kinnafick F, King J, Millard L, Arya D, Hodgson E, Huggins M, Simmons-Roberts A, O'Dowd M, Rayment N, Shah P, Breen KC. The Effect of Semaglutide With Lifestyle Intervention on the Physical Health of Patients Treated With Antipsychotic Drugs in a Secure Mental Health Setting: Protocol for an Uncontrolled Pretest-Posttest Pilot Mixed Methods Study. JMIR Res Protoc. 2025 Dec 9;14:e76013. doi: 10.2196/76013.
PubMed 41364787
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06754163
- Acronym / sponsor ID
- STEP@STAH / 2024/254
- Keywords
- semaglutide, wegovy, GLP-1 agonist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- St Andrew's HealthcareUniversity, hospital or other
- Collaborators
- Loughborough University
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Detailed description
The purpose of the study is to determine whether patients who have gained weight due to being prescribed anti- psychotic drugs (olanzapine or clozapine) and have become clinically obese (BMI>35.0) will react to the GLP-1 agonist class of drugs, including semaglutide (Wegovy®), which have been authorised for the treatment of patients as an adjunct to diet and exercise and for weight loss. These have been demonstrated to be effective in adults who are obese due to general overeating and lack of exercise (general lifestyle factors). However, there have been no studies carried out on patients who have had drug-induced weight gain where the drugs have had their impact, at least in part, by altering the body's metabolism. However, weight gain for patients who are treated with anti-psychotic medication is a complex issue as it cannot be solely ascribed to the drugs, as these people tend to be less active and by default to be more immobile. Therefore, the aim of this study is to determine whether GLP-1 agonists (and specifically semaglutide), in combination with dietary and exercise advice (the "NEW You" healthy lifestyle programme) will have a similar impact to those who are obese due to an unhealthy lifestyle which is not drug-induced. Patients are acutely aware of the impact of anti-psychotic medication on their weight and have discussed options with their clinicians.
However, they realise that exercise alone is not sufficient, and that certain drugs increase appetite. Therefore, informal discussions have led to a discussion on the potential use of medication which may assist in weight loss in conjunction with an overall healthy lifestyle (diet and exercise). This was part of the impetus to develop the trial initially at St Andrew's. However, in order to ensure that the evidence generated was robust, it was decided that it should be in the form of a phase 4 observational trial with specific outcome measures. As it would not be feasible to have a placebo control group, it will be in the form of a pre-post analysis.
Recruitment:
Patients who are eligible to enrol in the trial will be identified by their responsible clinician. They will then be approached by a member of the research team who will explain the trial, what it involves and the potential benefits. In particular, they will be made aware that the programme is not just a drug trial but will also involve engagement in a healthy lifestyle programme where the participants will be encouraged to become aware of their diet and also to engage in exercise. Expert members of the multidisciplinary team will provide support throughout the trial and the participants will be made aware of this through the research team. The trial will also be an integral part of their care plan.
Consent:
Patients should be deemed by their responsible clinician as being capable of giving consent to participate in the study and to engage in the interventions such as keeping a food, exercise and sleep diary with the assistance of a staff member.
Risks, burdens and benefits:
As Wegovy is a routinely available drug that will be prescribed under NICE guidelines with patients and staff being made aware of the potential side effects, the risks will be minimal. Full information about the trial will be available in the patient information sheet and support information will be available in the NEW You healthy lifestyle programme documentation which was developed at St Andrew's in 2020 as part of an NHS Commissioning and Quality Innovation (CQUIN) Framework with significant patient input. Participation in the study should result in an overall healthier lifestyle with a greater awareness of diet and exercise, with support from staff and an improved physical health. Participants will be encouraged to monitor their food, activity and sleep (FAS diary), which will increase their awareness of a healthy lifestyle and the benefits thereof. The majority of outcome measures will be routine measures (BMI, blood pressure) and there will be three additional questionnaires administered every three months, each taking approximately ten minutes. The patients will also undergo questionnaires to assess their attitude towards the study (qualitative research) prior to the start of the study, at 12 months and upon completion of the study. This will be should take up to 15 minutes. These will be carried out at the patient's own convenience. Additionally, the patient will be asked to wear an activity monitor (in the form of a watch) for one week every three months. This has been used in previous exercise- based studies at St Andrew's and they have been shown to be well tolerated and the patients are interested to understand the amount of activity that they undergo on a daily basis. .
Confidentiality:
All of the data collected during the study will stored in a password-protected file on the St Andrew's server and only available to names members of the research team. This is highlighted in the patient information sheet.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Evaluating the Effect of the STEP Protocol on Physical Health Measures | Experimental | Drug: Semaglutide in combination with a healthy lifestyle intervention (diet and exercise)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide 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. | Drug | Evaluating the Effect of the STEP Protocol on Physical Health Measures |
Primary outcome
Weight
Time frame: 36 months
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.
Body mass index
Time frame: 36 months
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
Waist circumference
Time frame: 36 months
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.
Blood pressure
Time frame: 36 months
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.
Heart rate
Time frame: 36 months
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.
6 secondary outcomes
To explore the potential relationship between patient adherence to STEP@STAH and changes in quality of life
Time frame: 24 months
To explore the potential relationship between patient adherence to STEP@STAH and changes in wellbeing
Time frame: 24 months
To explore the potential relationship between patient adherence to STEP@STAH and changes in wellbeing
Time frame: 24 months
To explore the potential relationship between patient adherence to STEP@STAH and changes in physical activity
Time frame: 24 months
To explore the potential relationship between co-morbidities and impact of STEP@STAH
Time frame: 24 months
To qualitatively explore the barriers, facilitators and acceptability of the intervention from both patient and staff perspectives
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Derived from this study: PubMed 41364787Brenisin K, Kinnafick F, King J, Millard L, Arya D, Hodgson E, Huggins M, Simmons-Roberts A, O'Dowd M, Rayment N, Shah P, Breen KC. The Effect of Semaglutide With Lifestyle Intervention on the Physical Health of Patients Treated With Antipsychotic Drugs in a Secure Mental Health Setting: Protocol for an Uncontrolled Pretest-Posttest Pilot Mixed Methods Study. JMIR Res Protoc. 2025 Dec 9;14:e76013. doi: 10.2196/76013.
- Individual participant dataSharing planned: Yes. Anonymised physical healthcare data on clinical outcomes will be available upon request upon completion of the study
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Obesity and Obesity-related Medical Conditions, Bariatric Surgery
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Randomized Control Trial of Sleeve Gastrectomy With Tirzepatide in Maximizing Weight Loss
Obesity and Obesity-related Medical Conditions
Recruiting
A Wearable Device and AI-Supported Diet and Exercise Intervention
Obesity and Obesity-related Medical Conditions
Recruiting
Metabolic Effects of Short-term Ultra-processed Food Intake (MEST-UPF)
Appetite, Obesity and Obesity-related Medical Conditions
Active, not recruitingPhase 4
Bariatric Surgery vs. Semaglutide vs. Tirzepatide
Obesity and Obesity-related Medical Conditions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kieran C Breen, PhD principal investigator
St Andrew's Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide in combination with a healthy lifestyle intervention (diet and exercise) in people with Obesity and Obesity-related Medical Conditions and Psychiatric Disorders, run by St Andrew's Healthcare at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 36 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06754163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.