NCT05193578CompletedPhase 2
Home-based Intervention With Semaglutide Treatment Of Neuroleptica-Related Prediabetes
Source: ClinicalTrials.gov · Last updated 8 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 154 (actual)
- First submitted
- 9 Dec 2021
- Start date
- 1 Jan 2022
- Primary completion date
- 18 Mar 2024
- Lead sponsor
- Jan Frystyk
- Diseases
- Schizophrenia
- NCT number
- NCT05193578
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 154
- From 1 Jan 2022 to the primary completion date, 18 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with study drug or use of other weight reducing drugs within the last 6 month
- Participation in other drug trials
- Treatment with drugs approved for overt diabetes type 2. (Metformin not included)
Other illness
- Active malignant disease within the last 5 years
Lab values
- Diagnosis of diabetes (T1D or T2D) or a HbA1c \>47 mmol/mol
- Significant somatic disease: 1) end-stage renal failure (eGFR \<15 ml/min); 2) elevated liver function tests (liver transaminases \>2 times upper normal limit); 3) history of acute or chronic pancreatitis; 4) heart failure (NYHA class IV) or unstable angina pectoris or myocardial infarction with the last 6 months; 5) uncontrolled hypertension (systolic blood pressure \>180 mm Hg, diastolic blood pressure \>100 mm Hg)
Other
- Pregnancy or breast feeding
- Exceeding high risk consumption limit (\>21 / 14 units of alcohol for men / women, respectively) or severe substance abuse
- Unwillingness to allow home visits by a study nurse
- Circumstances that the investigator believes will interfere with the trial
Who the study is looking for
- Diagnosed with schizophrenia spectrum disorder (ICD10 codes DF20, DF21 or DF25)
- Age between 18 and 60 years (both included)
- Approved contraception for female participants
- Treated by one of the OPUS clinics and or community psychiatry centers teams and community psychiatry in the Region of Southern Denmark or Zealand
- Antipsychotic SGA treatment for at least 6 months
- Stable co-medication for at least 1 month
- HbA1c between 39-47 mmol/mol (both included). Two measurements with ≥3 month interval are required to confirm prediabetes. The first measurement is identified and obtained from patient journals, the second prior to enrolment
- BMI ≥27 kg/m2. Two weights with ≥3 month interval are required to confirm obesity
- Capable of providing informed oral and written consent
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
Related publications
- Cardiac autonomic neuropathy in patients with SGA-treated schizophrenia: a randomized controlled trial of 30 weeks' treatment with semaglutide.Cardiovasc Diabetol Endocrinol Rep · 2026 · PMID 41555458
This page is information, not medical advice. Discuss any trial with your doctor.