Study S001361

Home-based Intervention With Semaglutide Treatment Of Neuroleptica-Related Prediabetes

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

Included trial: extracted data ClinicalTrials.gov record Statistical Analysis Plan (PDF)

Registration

Registration: NCT05193578
Acronym: HISTORI
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 154
Start: 2022-01-01
Primary completion: 2024-03-18
Lead sponsor: Jan Frystyk
Conditions: Schizophrenia; Prediabetic State
Interventions: DRUG:Semaglutide, 1.34 mg/mL; OTHER:Placebo
Results posted: FALSE
Individual participant data sharing: YES

Registered primary outcomes

HbA1c (mmol/mol) [30 weeks]

Linked records (3)

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
R0007772	Cardiac autonomic neuropathy in patients with SGA-treated schizophrenia: a randomized controlled trial of 30 weeks' treatment with semaglutide. Ganeshalingam AA, Cardiovascular diabetology. Endocrinology reports	2026	Randomized trial	PMID 41555458 DOI	cites ClinicalTrials.gov:NCT05193578; registry reference DERIVED:41555458
R0006489	Semaglutide Treatment of Antipsychotic-Treated Patients With Schizophrenia, Prediabetes, and Obesity: The HISTORI Randomized Clinical Trial. Ganeshalingam AA, JAMA psychiatry	2025	Randomized trial	PMID 40900607 DOI	cites ClinicalTrials.gov:NCT05193578; registry reference DERIVED:40900607
R0011939	Home-based Intervention with Semaglutide Treatment of Neuroleptic-Related Prediabetes (HISTORI): protocol describing a prospective, randomised, placebo controlled and double-blinded multicentre trial. Ganeshalingam AA, BMJ open	2024	Protocol	PMID 38503415 DOI	cites ClinicalTrials.gov:NCT05193578; registry reference DERIVED:38503415