Study outcomes
72.Additional, treatment-emergent adverse, deaths, weight loss
ADVERSE EVENTS, EVENTS, SECONDARY, ACUTE PANCREATITIS
Coprimary endpoints were per cent change in body weight and the proportion of study participants who achieved ≥5% weight reduction from randomization to week 72. Key secondary endpoints, controlled for type 1 error rate, included the proportion of study participants who achieved ≥10, ≥15 or ≥20% weight reduction from randomization to week 72. The proportion of study participants who achieved ≥25% reduction in body weight was a prespecified exploratory endpoint. Key secondary endpoints also included the proportion of participants who, at week 72, maintained ≥80% of the body weight loss achieved during the 12-week lead-in period, as well as change in waist circumference (cm) from randomization to week 72.Additional secondary endpoints included change in anthropometrics (absolute body weight and BMI), cardiometabolic risk factors (blood pressure, lipids, fasting glucose, HbAIn addition, changes in the intensity of antihypertensive and lipid-lowering therapies in the double-blind period, as reported by the investigator, were assessed as prespecified exploratory endpoints.Safety endpoints included treatment-emergent adverse events and serious adverse events that occurred during the reporting period. Major adverse cardiovascular events, acute pancreatitis and deaths were reviewed by an independent external adjudication committee.