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

What Was Tested

The trial (phase 4) is built around Semaglutide.

It had 1 arm (groups): Evaluating the Effect of the STEP Protocol on Physical Health Measures (experimental).

The registry classes the interventions as drug.

More on the Plan

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.

Patients are acutely aware of the impact of anti-psychotic medication on their weight and have discussed options with their clinicians.

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).

Who Took Part

20 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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. Currently prescribed olanzapine or clozapine. Sufficient level of English to read and understand the information sheet (may require verbal explanation from support from staff).

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2025-01-01 with completion listed for 2027-07-31.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Weight (time frame: 36 months). Body mass index (time frame: 36 months). Waist circumference (time frame: 36 months).

It also tracked 6 secondary outcomes, for example To explore the potential relationship between patient adherence to STEP@STAH and changes in quality of life, To explore the potential relationship between patient adherence to STEP@STAH and changes in wellbeing, To explore the potential relationship between patient adherence to STEP@STAH and changes in wellbeing, To explore the potential relationship between patient adherence to STEP@STAH and changes in physical activity, To explore the potential relationship between co-morbidities and impact of STEP@STAH and To qualitatively explore the barriers, facilitators and acceptability of the intervention from both patient and staff perspectives.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Semaglutide in 20 people.

Its size is small, so on its own it can only give an early look.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.