Endpoints
weight loss, C-SSRS, Diabetes
ADVERSE EVENTS, HYPOGLYCAEMIC EPISODE, EVENT, DIABETES
The primary endpoint was percentage change from baseline to week 24 in body weight. Secondary efficacy endpoints included proportion of participants achieving body weight loss of 5% or more and 10% or more from baseline to week 24, change from baseline to week 24 in body weight, waist circumference and BMI, change from baseline to week 24 in glucose metabolism parameters (HbA1c, fasting plasma glucose and fasting insulin), changes from baseline to week 24 in cardiovascular risk factors (blood pressure, lipids [total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides]), changes from baseline to week 12 and week 24 in serum uric acid and ALT, changes in IWQOL-Lite scores, as well as changes from baseline to week 36 in body weight, waist circumference, BMI, glucose and cardio-metabolic risk factors.Safety endpoints included safety, tolerability and immunogenicity of mazdutide. Safety was assessed by adverse events, vital signs, laboratory investigations and electrocardiogram. Treatment-emergent adverse events (TEAEs) were monitored from day 1 to the end of off-treatment follow-up and were categorised according to the Medical Dictionary for Regulatory Activities system organ class and preferred terms. The severity of the TEAEs (mild, moderate or severe) and the association between an event and the study treatment was assessed by investigators based on pre-specified criteria. Hypoglycaemic episodes were identified by self-report or a plasma glucose concentration of 3.9 mmol/L or less at a site visit, and graded according to the American Diabetes Association criteria. Secondary safety endpoints also included C-SSRS and PHQ-9 assessments.