Evaluating the effects of semaglutide on weight loss in patients treated with atypical antipsychotics
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
This study is testing if the weight loss medication semaglutide can help people who have gained weight from taking certain psychiatric medications lose weight while also following a healthy lifestyle plan.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St Andrew's Healthcare Academic / other |
| Locations | 1 site (Northampton) |
| Trial ID | NCT06754163 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of semaglutide, a GLP-1 agonist, in promoting weight loss among patients who have gained weight due to the use of atypical antipsychotic medications like olanzapine or clozapine. Participants will receive semaglutide alongside a healthy lifestyle intervention that includes dietary and exercise advice. The study focuses on patients with a BMI of 35.0 or higher, particularly those in secure care settings where mobility may be restricted. By evaluating the long-term effects of this treatment, the study seeks to provide insights into managing drug-induced obesity in psychiatric patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over, currently prescribed olanzapine or clozapine, and with a BMI of 35.0 or higher.
Not a fit: Patients under 18, those with contraindications to semaglutide, or those with severe cognitive impairments will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly aid in weight management for patients struggling with obesity due to antipsychotic medications.
How similar studies have performed: While there have been successful studies on GLP-1 agonists for general obesity, this specific approach for drug-induced weight gain in psychiatric patients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Northampton
- St Andrew's Healthcare — Northampton, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Kieran C Breen, PhD — St Andrew's Healthcare
- Study coordinator: Kieran C Breen, PhD
- Email: kbreen@stah.org
- Phone: 00447879425837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.