Outcomes
weight loss, lean muscle mass
ADVERSE EVENTS, SECONDARY, ADVERSE EVENT
The primary end point was percentage change in body weight from baseline to week 24. Body weight was measured using a weighing scale (Tanita DC-430MAS) with participants wearing light clothes and no shoes to the nearest 0.1 kg. Percentage body weight loss was calculated as 100 × [(body weight at baseline − body weight at week 24) / body weight at baseline].Secondary outcomes included proportion of patients who lost at least 5% of their baseline body weight, change in body weight (kg) from baseline and change in body composition (fat mass, lean muscle mass, and bone mineral density) assessed using a whole-body dual energy X-ray absorptiometry (Discovery A DXA system version 13.4.2). Metabolic secondary outcomes included change from baseline in glycemic indices (fasting glucose, fasting insulin, and hemoglobin AHealth-related quality of life was assessed using European Quality of Life 5 Dimensions 3-Level Version and the Impact of Weight on Quality of Life-Lite questionnaires.Safety assessments included adverse event evaluation, physical examination, vital signs (blood pressure and pulse), laboratory parameters (kidney function and liver function), and pregnancy tests. An end of trial phone call was done to check for adverse events at week 28.