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

Summary

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.

Timeline

Start

2022-01-01

Primary completion

2024-03-18

Completion

2024-05-01

Publications

• Ganeshalingam AA, Uhrenholt NG, Arnfred S, Gaede P, Pedersen AK, Bilenberg N, Frystyk J. Cardiac autonomic neuropathy in patients with SGA-treated schizophrenia: a randomized controlled trial of 30 weeks' treatment with semaglutide. Cardiovasc Diabetol Endocrinol Rep. 2026 Jan 20;12(1):2. doi: 10.1186/s40842-025-00258-0.
• Ganeshalingam AA, Uhrenholt N, Arnfred S, Gaede P, During S, Stenager EN, Bunger N, Pedersen AK, Bilenberg N, Frystyk J. Semaglutide Treatment of Antipsychotic-Treated Patients With Schizophrenia, Prediabetes, and Obesity: The HISTORI Randomized Clinical Trial. JAMA Psychiatry. 2025 Nov 1;82(11):1065-1074. doi: 10.1001/jamapsychiatry.2025.2332.
• Ganeshalingam AA, Uhrenholt NG, Arnfred S, Gaede PH, Bilenberg N, Frystyk J. Home-based Intervention with Semaglutide Treatment of Neuroleptic-Related Prediabetes (HISTORI): protocol describing a prospective, randomised, placebo controlled and double-blinded multicentre trial. BMJ Open. 2024 Mar 18;14(3):e077173. doi: 10.1136/bmjopen-2023-077173.

Drugs

Indications