STEP 1Evaluación de Pérdida de Peso con Semaglutida en Individuos con Sobrepeso u Obesidad

Semaglutide

Placebo (semaglutide)

Change in Body Weight (%)

Participants Who Achieve 5 or More Percent Body Weight Reduction (Yes/no)

Subjects Who Achieve 10 or More Percent Body Weight Reduction (Yes/no)

Participants Who Achieve 15 or More Percent Body Weight Reduction (Yes/no)

Participants Who Achieve 20 or More Percent Body Weight Reduction (Yes/no)

Change in Waist Circumference (cm)

Change in Systolic Blood Pressure (mmHg)

Change in Short Form 36 (SF-36)

Change in Impact of Weight on Quality of Life-Lite for Clinical Trial (IWQoL-Lite for CT) Score

Change in Body Weight (kg)

Change in Body Mass Index (BMI) (kg/m2)

Change in HbA1C (%)

Change in HbA1C (mmol/Mol)

Change in Fasting Plasma Glucose (FPG) (mg/dL)

Change in Fasting Serum Insulin (mIU/L) - Ratio to Baseline

Change in Diastolic Blood Pressure (mmHg)

Change in Total Cholesterol (mg/dL) - Ratio to Baseline

Change in High-density Lipoproteins (HDL) (mg/dL) - Ratio to Baseline

Change in Low-density Lipoproteins (LDL) (mg/dL) - Ratio to Baseline

Change in Very Low-density Lipoproteins (VLDL) (mg/dL) - Ratio to Baseline

Change in Free Fatty Acids (mg/dL) - Ratio to Baseline

Change in Triglycerides (mg/dL) - Ratio to Baseline

Change in High Sensitivity C-Reactive Protein (hsCRP) - (mg/L) - Ratio to Baseline

Change in Plasminogen Activator Inhibitor-1 (PAI-1) Activity (AU/ml) - Ratio to Baseline

Change in Soluble Leptin Receptor (ng/mL) - Ratio to Baseline

Change in Leptin (ng/mL) - Ratio to Baseline

Change in Body Composition (Total Fat Mass) (%)

Change in Body Composition (Total Fat Mass) (kg)

Change in Body Composition (Lean Body Mass) (%)

Change in Body Composition (Lean Body Mass) (kg)

Change in Body Composition (Visceral Fat Mass) (%)

Change in Body Composition (Visceral Fat Mass) (kg)

Change in Body Weight (%) - DEXA Subpopulation

Change in Body Weight (kg) - DEXA Subpopulation

Participants Who Achieve "Responder Definition Value" (Yes/no) for SF-36 Physical Functioning Score

Participants Who Achieve "Responder Definition Value" (Yes/no) for IWQoL-Lite for CT Physical Function Domain (5-items) Score

Number of Treatment Emergent Adverse Events (TEAEs)

Number of Serious Adverse Events (SAEs)

Change in Pulse

Change in Amylase - Ratio to Baseline

Change in Lipase - Ratio to Baseline

Change in Calcitonin - Ratio to Baseline