STEP@STAH

Active not recruitingPhase 4

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

Lead sponsor

St Andrew's Healthcare

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Obesity / overweight, Psychiatric (schizophrenia / bipolar / depression)

Key I/E criterion

—

Primary endpoints

•Body weight, absolute change (kg)•Body mass index•Waist circumference, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06754163

Org study ID2024/254

Timeline

Milestones

Study first posted2024-12-31actual

Study start2025-01-01actual

Last update posted2026-04-28actual

Primary completion2027-07-31estimated

Study completion2027-12-30estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweightPsychiatric (schizophrenia / bipolar / depression)

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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 at St Andrew's Healthcare

•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

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Patient-reported / QoL

Cardiometabolic biomarkers

Other (unclassified)

Other clinical outcomes

Weight & body composition

3 endpoints

Primary/protocol endpoint

Weight

Time frame:36 months

Body weight, absolute change (kg)

change from baseline, improvement

Primary/protocol endpoint

Body mass index

Time frame:36 months

descriptive, improvement

Primary/protocol endpoint

Waist circumference

Time frame:36 months

Waist circumference, change

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Primary/protocol endpoint

Blood pressure

Time frame:36 months

descriptive, improvement

Primary/protocol endpoint

Heart rate

Time frame:36 months

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

3 endpoints

Secondary/protocol endpoint

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

Time frame:24 months

IWQOL-Lite total

change from baseline, improvement