7 results
Primary objectives: -To evaluate the PK profile of OBE001 when administered orally to pregnant women.Secondary objectives: -To evaluate the maternal safety and tolerability of OBE001 when administered orally to pregnant women.-To evaluate the acute…
Primary Objectives: a. Optimization of the 99MTc-HABN SPECT/CT scanning protocol in the first 5 patients (Phase 0). b. Detection and characterization of primary prostate cancer (tumor uptake and tumor-to-background ratio) in patients with 99MTc-HABN…
The primary objective of the study is to determine the proportion of patients with elevated TGs, without Familial ChylomicronemiaSyndrome (FCS) due to loss of function (LoF) mutations in lipoprotein lipase (LPL), and a history of…
PrimaryThe primary objective for Part A of the study is to assess the pharmacokinetics (PK) of evinacumab in pediatric patients with homozygous familial hypercholesterolemia (HoFH).The primary objective for Part B of the study is to demonstrate a…
Please refer to protocol, section 1.2 "Rationale"
The primary objective of the study is:* To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by evinacumab 15 mg/kg intravenously (IV) in comparison to placebo after 24 weeks in patients with homozygous familial…
The primary objectives of the study are- To evaluate the long-term safety and tolerability of evinacumab 15 mg/kg intravenous (IV) administered every 4 weeks (Q4W) in patients with homozygous familial hypercholesterolemia (HoFH).- To evaluate the…