* LIBerate-OLE

• Research type

  Research Study

• Full title

  Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With Homozygous and Heterozygous Familial Hypercholesterolemia, Cardiovascular Disease, or at High Risk for Cardiovascular Disease, on Stable Lipid-Lowering Therapy Requiring Additional Low-Density Lipoprotein Cholesterol Reduction (LIBerate-OLE)

• IRAS ID

  292742

• Contact name

  Minal Kara

• Contact email

  m.kara@medpace.com

• Sponsor organisation

  LIB Therapeutics, LLC

• Eudract number

  2020-004394-49

• Clinicaltrials.gov Identifier

  NCT04798430

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Atherosclerotic cardiovascular(CV) disease (ASCVD) is the main cause of morbidity and mortality in industrialised countries and despite progress in treatment, is projected to cause >22 million deaths over the next 15 years.
  Lowdensity lipoprotein cholesterol (LDL-C) has been identified as 1 of the major, and easily modifiable, risk factors for atherosclerosis. The introduction of statin therapy has transformed the treatment of CVD and is now widely used to
  reduce LDL-C in patients with existing ASCVD and those at increased CV risk. However, there remains an unmet medical need for additional LDL-C reduction in some patients including those unable to tolerate statins or effective doses of statins and those with higher LDL-C levels.

  The primary objectives of this study are to assess the long-term safety, tolerability, and efficacy after 48 and 72 weeks with monthly dosing of LIB003 300 mg administered subcutaneously (SC). The study includes patients at very-high risk for CVD or at high risk for CVD (including HoFH and HeFH) on a stable diet and maximally tolerated oral LDL-C lowering drug therapy who completed a LIB003 Phase 3 base study.

  Approximately 2000 males and females who fulfill all of the inclusion criteria and none of the exclusion criteria will be enrolled at up to 120 sites worldwide.

  All patients will receive LIB003 300 mg SC every 4 weeks.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  22/SC/0298

• Date of REC Opinion

  11 Jan 2022

• REC opinion

  Further Information Favourable Opinion