Efficacy and Safety of Semaglutide Versus Placebo on Cardiometabolic Profile in Patients With Schizophrenia With Metabolic Syndrome

QRISK3 is a cardiovascular risk prediction tool that calculates the 10-year absolute risk of developing cardiovascular disease (heart attack or stroke). The scale produces a percentage score ranging from 0% to 100%, where 0% represents minimum cardiovascular risk and 100% represents maximum theoretical risk. Risk stratification is typically classified as: <5% = low risk, 5-10% = intermediate risk, 10-20% = high risk, and >20% = very high risk. A score of >20% (or approaching 100%) represents the worst clinical situation, indicating substantially elevated 10-year cardiovascular disease risk requiring intensive preventive interventions, including lifestyle modification and pharmacological treatment (statins, antihypertensives). QRISK3 incorporates clinical variables (age, blood pressure, cholesterol), demographic factors, and comorbidities to stratify risk and guide evidence-based prevention strategies in primary care settings.

Change from baseline in lipid ratio from fasting lipid profile

Change in HOMA-IR from fasting glucose and serum insulin

Change in hs-CRP measured by ELISA

Anthropometric change from baseline

Change in metabolic biomarker measured by ELISA

Change in Positive and Negative Syndrome Scale (psychiatric safety), The assessment instrument employs a standardized scoring mechanism with a theoretical range spanning from a minimum of 30 to a maximum of 210 points. This metric demonstrates an inverse relationship between numerical score and outcome favorability; therefore, higher scores are indicative of more severe or unfavorable conditions, whereas lower scores denote relatively improved or more favorable circumstances. Consequently, respondents achieving scores proximate to the minimum threshold (30) represent optimal outcomes, while those obtaining scores approaching the maximum threshold (210) signify substantially compromised or critical situations requiring immediate clinical or interventional consideration.

The CGI-SCH is a clinician-rated assessment scale measuring overall severity of schizophrenia symptoms. The scale ranges from 1 to 7, where 1 represents "normal, not at all ill" (minimum score) and 7 represents "among the most extremely ill" (maximum score). Scores are interpreted as: 1-2 = normal to borderline, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = most extremely ill. A score of 7 indicates the worst clinical situation, reflecting severe and pervasive psychotic symptoms with significant functional impairment. The CGI-SCH is widely used in clinical trials and practice to track global severity and treatment response in schizophrenia over time.

The WHO QOL-BREF is a 26-item self-report instrument measuring overall quality of life across four domains: Physical Health, Psychological Health, Social Relationships, and Environment. Each item is rated on a 1-5 scale, yielding a minimum total score of 26 (poorest quality of life) and a maximum total score of 130 (best quality of life). Unlike severity scales, higher scores indicate better quality of life, while lower scores indicate poorer quality of life. A score of 26 represents the worst clinical situation, reflecting severely compromised physical health, psychological distress, social isolation, and inadequate environmental resources. Domain scores range from 4-20 each and can be analyzed separately to identify specific areas of impairment. The WHO QOL-BREF is widely used in clinical practice and research to evaluate functional quality of life, treatment outcomes, and overall well-being in various populations.

Frequency and severity of TEAEs; safety and tolerability