Endpoints
toxicity, fasting TG, stool occult blood
ADVERSE EVENTS, EVENTS, SECONDARY
The primary endpoints were incidence of adverse events or serious advserse events and relationship to study treatment; physical examinations, including height, weight and BMI; vital signs (systolic/diastolic blood pressure, temperature, heart rate and respiratory rate); electrocardiogram (ECG) measurements; injection site reactions; clinical laboratory tests (serum chemistry (including hemoglobin A1c), hematology, coagulation, urinalysis, microscopic urinalysis (if indicated), serology, follicle stimulating hormone (FSH), drug and alcohol use, pregnancy, lipid parameters, serum insulin levels, serum glucose levels and stool occult blood test); concomitant medications/therapy; and reasons for treatment discontinuation due to toxicity.The secondary pharmacodynamic endpoint was change in fasting serum ANGPTL3 concentration. The exploratory key pharmacodynamic endpoints included fasting TG, fasting non-HDL-C, fasting VLDL-C, fasting LDL-C, fasting HDL-C and ApoB in response to escalating single or multiple doses of ARO-ANG3.Additional lipid parameters, including ApoC III and total cholesterol, were also assessed as exploratory endpoints.Full lists of secondary and exploratory endpoints are included below.