A phase 2, randomised, double-blind, placebo-controlled trial to evaluate safety and local tolerability of four weekly administrations of A24110He in subjects with elevated triglyceride plasma concentrations

Moderate to severe hypertriglyceridemia

Physical examination, Assessment of local tolerability, Vital signs: systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate, body temperature, 12- lead ECG, Safety laboratory tests - Clinical chemistry: creatinine (eGFR), cystatin C (eGFR), ASAT, ALAT, bilirubin, GGT, alkaline phosphatase, albumin, bicarbonate, chloride, phosphate, urea, potassium, calcium, sodium, fasting plasma glucose (FPG), f-insulin, HbA1c, C-reactive protein (CRP), TSH, LDH, Safety laboratory tests - Haematology: haemoglobin, EVF, MCV, MHC, MCHC, erythrocyte count, platelet count, leucocyte count with differential count, haptoglobin, Safety laboratory tests - Coagulation: APTT, INR, Safety laboratory tests - Urinalysis: erythrocytes, glucose, ketones, leucocytes, nitrite, pH, protein, hCG (women of childbearing potential only), albumin, creatinine, urinary albumin/creatinine ratio, Frequency, seriousness, intensity of adverse events (AEs)

Plasma concentrations and PK parameters of A24110He. PK parameters to be determined: a) Maximum plasma concentration (Cmax); b) Time to Cmax (Tmax); c) Terminal half-life (t½) after the fourth dose. Cmax and Tmax will be evaluated in sampling frame up to 4 hours after dosing., Fasting triglyceride levels (clinical routine enzymatic assay), Triglyceride-glucose (TyG) index based on fasting triglyceride and glucose levels

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