Record status This record was last updated September 25, 2024 (before its estimated March 1, 2026 completion). Its status may not reflect the trial's current state.
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MinorChangedRegistry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
MinorRe-verified, no change to tracked fieldsv7
NotablePrimary completion date: Sep 1, 2024 to Mar 1, 2026
Study completion date: Dec 31, 2024 to Aug 1, 2026
v6
MinorTrial status: Recruiting to Active, Not Recruiting
Primary completion date: Jul 1, 2024 to Sep 1, 2024
Site details revised at 3 of 3 sites
v5
MinorPrimary completion date: Sep 30, 2024 to Jul 1, 2024
Eligibility criteria revised
v4
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NotableTrial status: Not Yet Recruiting to Recruitingv3Show 6 more changesShow less
Primary completion date: Oct 31, 2023 to Sep 30, 2024
Study sites: 1 to 3
Study completion date: Dec 31, 2023 to Dec 31, 2024
Start date changed from estimate of Aug 2, 2021 to Sep 1, 2021
Eligibility criteria shortened, about 69 words
Secondary endpoints: 23 to 24
NotableStart date: May 31, 2021 to Aug 2, 2021v2
MinorStudy First Submitted
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background and objective:
Clozapine and olanzapine are some of the most effective antipsychotic drugs, but unfortunately, both drugs induce weight gain and conveys a high degree of metabolic disturbances. The antipsychotic-induced side-effects cause a major clinical problem among patients diagnosed with schizophrenia receiving antipsychotic treatment. Limited effects have been demonstrated for counteracting the side-effects by the switch of antipsychotic therapy, non-pharmacological/behavioural interventions or adjunct pharmacological treatments. Semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA,) is approved for the treatment of type 2 diabetes worldwide. The objective of the study is to investigate effects of semaglutide once-weekly vs. semaglutide placebo once-weekly on the metabolic state in prediabetic or diabetic patients with schizophrenia, who have initiated treatment with clozapine or olanzapine.
Methods and analysis:
Trial design, intervention and participants: The study is a 26-week, double-blinded, randomized, parallel-group, placebo-controlled, good clinical practice (GCP)-monitored, clinical trial. 104 prediabetic or diabetic patients diagnosed with a schizophrenia, age 18 years and 65 years, who have initiated of clozapine- or olanzapine-treatment within 5 years will be included in the study. The patients will be randomized to receive blinded treatment in one of the two study arms; semaglutide once-weekly vs. semaglutide placebo. All participants who complete the 26 weeks of intervention, will be invited for a follow up visit 1.5 yeras after study completion.
The primary endpoint is the change from baseline in glycated haemoglobin A1c (HbA1c). Secondary endpoints include change in body weight, hip and waist circumference, vitals, and plasma levels of insulin, glucose, C-peptid, insulin sensitivity, beta cell function, glucagon, liver function, lipid profile, incretin hormones, lipid profile, bone makers, body composition, bone density and proteomic analyses. Additional endpoints include alcohol, tobacco and drug use, food preferences, psychopathology, activity and quality of life.