Home-based Intervention With Semaglutide Treatment Of Neuroleptica-Related Prediabetes
- Status
- CompletedResults none
- Why it is watched
- non-weight indication: psychiatric
- Who it enrolls
- age 18 Years to 60 Years; BMI ≥27 required; conditions: Schizophrenia; Prediabetic State
- Interventions
- Semaglutide, 1.34 mg/mL; Placebo
- Conditions
- Schizophrenia; Prediabetic State
- Phase and size
- Phase 2 · 154 participants
- Dates
- Start 2022-01-01
Primary completion 2024-03-18 - Sponsor
- Jan Frystyk (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- HbA1c (mmol/mol)30 weeks
02Eligibility
Who can take part
Inclusion Criteria: * 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 Exclusion Criteria: * Diagnosis of diabetes (T1D or T2D) or a HbA1c \>47 mmol/mol * Active malignant disease within the last 5 years * 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 * 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) * 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) * Circumstances that the investigator believes will interfere with the trial
03Change log
Registry changes
No changes recorded since the trial was added.