A Phase 2 Study with AMG 145 in Subjects With Hypercholesterolemia

• Research type

  Research Study

• Full title

  A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Subjects with Heterozygous Familial Hypercholesterolemia

• IRAS ID

  81347

• Contact name

  Michael Feher

• Sponsor organisation

  Amgen Ltd.

• Eudract number

  2011‐001528‐39

• ISRCTN Number

  not known

• Research summary

  This is a phase 2, double-blind, multi-centre, placebo-controlled, randomised study with the same allocation to one of the following 3 arms: 350 mg or 420 mg AMG 145 every-4-weeks (Q4W) subcutaneous (SC), or placebo every-4-weeks subcutaneous. Patients being considered for eligibility to this study, and who have signed informed consent, will undergo screening labs, including fasting lipids, and will receive 6 mL placebo by subcutaneous injections to start the placebo run-in period at any time during the screening period. If screening labs confirm eligibility, patients will return to the study site within 5 - 10 days of LDL-C screening for randomisation and treatment initiation.Patients will receive 6 mL of study drug subcutaneously once every 4 weeks for 12 weeks and will complete the study with the end-of-study (EOS) visit and the last estimation of lipids at week 12. The dose at each administration can be split into more than 1 injection.The study includes collection of biomarker samples and all patients will be invited to participate in pharmacogenetic analyses.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  11/LO/1064

• Date of REC Opinion

  12 Aug 2011

• REC opinion

  Further Information Favourable Opinion