Real‐World Evidence of the Effectiveness and Safety of Biosynthetic Semaglutide in Type 2 Diabetes: A Multicentre Study From Pakistan

AIMS: To evaluate the real-world effectiveness, safety and patient-reported outcomes of biosynthetic semaglutide in adults with type 2 diabetes mellitus (T2DM) receiving routine outpatient care in a cost-constrained setting. METHODS: This 30-week, prospective, multicentre, non-interventional study enrolled adults with T2DM initiating biosynthetic semaglutide. The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to end of study (EOS). Secondary endpoints included changes in body weight, waist circumference, patient-reported outcomes (DTSQs and SF-36v2) and safety. RESULTS: Among 217 patients, mean HbA1c decreased from 9.27% to 7.41% at EOS (-1.86%; p < 0.001). At EOS, 76.6% achieved HbA1c < 8.0% and 38.7% achieved < 7.0%. Mean body weight decreased by -7.84 kg (p < 0.001), with 76.5% achieving ≥ 5% weight loss. Significant reductions were also observed in body mass index and waist circumference. Treatment satisfaction and physical quality of life improved significantly. Adverse events were predominantly non-serious and gastrointestinal. No severe hypoglycaemic episodes occurred. CONCLUSIONS: In routine clinical practice, biosynthetic semaglutide was associated with clinically meaningful improvements in glycaemic control, body weight and physical quality of life. The safety profile remained consistent with established semaglutide therapy. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12625000610437.