Clinical trial
Evaluating the Effect of the STEP@STAH Semaglutide Protocol on the Physical Health Measures of Atypical Antipsychotic-Treated Patients
Active, not recruiting · Phase 4 · 1 countries · Registry ID NCT06754163
What this study is about
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."
Basic eligibility
Full registry criteria
Treatments and study 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.
Primary outcomes
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.
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 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.
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.
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.
Study locations
1 locations were listed when this page was built. The first 40 are shown.