NCT05193578 (HISTORI) is a Phase 2 clinical trial of Semaglutide, 1.34 mg/mL in Schizophrenia, sponsored by Jan Frystyk.

Who is sponsoring NCT05193578?

NCT05193578 is sponsored by Jan Frystyk.

What drugs are being tested in NCT05193578?

Interventions in NCT05193578: Semaglutide, 1.34 mg/mL, Placebo.

What condition does NCT05193578 study?

NCT05193578 studies Schizophrenia, Prediabetic State.

Is NCT05193578 still recruiting?

NCT05193578 is currently completed. Last updated 8 July 2024.

Last reviewed 2024-07-08 · How we verify

NCT05193578: HISTORI

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 8 July 2024

What this trial tests

Phase 2 trial testing Semaglutide, 1.34 mg/mL in Schizophrenia in 154 participants. Completed in 1 May 2024.

Timeline

1 January 2022

Primary endpoint
18 March 2024

1 May 2024

Quick facts

Lead sponsor	Jan Frystyk
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	154
Start date	1 January 2022
Primary completion	18 March 2024
Estimated completion	1 May 2024
Sites	1 location across Denmark

Drugs / interventions tested

Semaglutide, 1.34 mg/mL — full drug profile →
Placebo

Conditions studied

Schizophrenia — all drugs for Schizophrenia →
Prediabetic State — all drugs for Prediabetic State →

Sponsor

Jan Frystyk

Who can join

Adults 18 to 60, any sex, with Schizophrenia or Prediabetic State. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To investigate whether the Glucagon Like Peptide 1 (GLP-1) Semaglutide (1.34 mg/ml) has preventive effect compared to placebo in the development of diabetes and Metabolic Syndrome in people with pre-diabetes, overweight and schizophrenia, who receive antipsychotic treatment. Furthermore to investigate for an effect of Semaglutide compared to placebo on psychotic symptoms and quality of life in people with schizophrenia, prediabetes and overweight.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Semaglutide Treatment of Antipsychotic-Treated Patients With Schizophrenia, Prediabetes, and Obesity: The HISTORI Randomized Clinical Trial.
Ganeshalingam AA, Uhrenholt N, Arnfred S, Gæde P, et al · · 2025 · cited 9× · PMID 40900607 · DOI 10.1001/jamapsychiatry.2025.2332
Semaglutide as a GLP-1 Agonist: A Breakthrough in Obesity Treatment.
Salvador R, Moutinho CG, Sousa C, Vinha AF, et al · · 2025 · cited 9× · PMID 40143174 · DOI 10.3390/ph18030399
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, Uhrenholt NG, Arnfred S, Gæde PH, et al · · 2024 · cited 7× · PMID 38503415 · DOI 10.1136/bmjopen-2023-077173
The safety and efficacy of semaglutide in people with schizophrenia spectrum disorders: systematic review and meta-analysis of randomised controlled trials.
Trott M, Arnautovska U, Johnston D, Ritchie G, et al · · 2026 · PMID 42179170 · DOI 10.1192/bjo.2026.12001
Semaglutide Effects on Insulin Sensitivity and β-Cell Function in Patients With Schizophrenia, Prediabetes, and Obesity Treated With Second-Generation Antipsychotics: Findings From the HISTORI Trial, a 30-Week Randomized, Placebo-Controlled Trial With Semaglutide 1.0 mg Weekly.
Ganeshalingam AA, Uhrenholt N, Arnfred S, Gæde P, et al · · 2026 · PMID 41778920 · DOI 10.2337/dc25-2041
Cardiac autonomic neuropathy in patients with SGA-treated schizophrenia: a randomized controlled trial of 30 weeks' treatment with semaglutide.
Ganeshalingam AA, Uhrenholt NG, Arnfred S, Gæde P, et al · · 2026 · PMID 41555458 · DOI 10.1186/s40842-025-00258-0

Verify or expand the search:

Other trials of Semaglutide, 1.34 mg/mL

Trials testing the same drug.

NCT06954090 — Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Study · Phase 4 · enrolling by invitation
NCT05702905 — Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome · Phase 4 · unknown
NCT04892199 — Does GLP-1RA Prevent Deterioration of Metabolic State in Prediabetic and Diabetic Patients Treated With Antipsychotic Me · Phase 4 · active not recruiting
NCT04061200 — Renal Effects of Treatment With Empagliflozin Alone or in Combination With Semaglutide in Patients With Type 2 Diabetes · Phase 4 · unknown
NCT03598621 — A Research Study to Look at Similarity Between Semaglutide Versions in Different Injection Tools · Phase 1 · completed

Other recruiting trials for Schizophrenia

Currently open trials in the same condition.

NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au · Phase 3 · recruiting
NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia · Phase 2 · recruiting
NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting

Other Jan Frystyk trials

Trials by the same sponsor.

NCT05178537 — Cross-sectional Study of 1200 Recreational Athletes With Former or Current Use of Androgenic Anabolic Steroids · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05193578 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jan Frystyk
Last refreshed: 8 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05193578.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing