Study S001293

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 record

Registration

Registration: NCT06754163
Acronym: STEP@STAH
Study type: INTERVENTIONAL
Phase: PHASE4
Masking: NONE
Status: ACTIVE_NOT_RECRUITING
Enrollment: 20
Start: 2025-01-01
Primary completion: 2027-07-31
Lead sponsor: St Andrew's Healthcare
Conditions: Obesity and Obesity-related Medical Conditions; Psychiatric Disorders
Interventions: DRUG:Semaglutide in combination with a healthy lifestyle intervention (diet and exercise)
Results posted: FALSE
Individual participant data sharing: YES

Registered primary outcomes

Weight [36 months]
Body mass index [36 months]
Waist circumference [36 months]
Blood pressure [36 months]
Heart rate [36 months]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0004740	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. Brenisin K, JMIR research protocols	2025	Protocol	PMID 41364787 DOI	cites ClinicalTrials.gov:NCT06754163; registry reference DERIVED:41364787