Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With HoFH and HeFH, CVD, or at High Risk for CVD, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction

Next Previous
Trial Profile

Open-Label Extension Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of LIB003 in Patients With HoFH and HeFH, CVD, or at High Risk for CVD, on Stable Lipid-Lowering Therapy Requiring Additional LDL-C Reduction

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 23 Dec 2024

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Lerodalcibep (Primary) ; Bempedoic acid; Bezafibrate; Bile acids and salts; Ezetimibe; Fenofibrate; HMG-CoA reductase inhibitors; Niacin; Omega-3-fatty-acid
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Adverse reactions; Registrational
  • Acronyms LIBerate-007; LIBerate-OLE
  • Sponsors LIB Therapeutics

Most Recent Events

  • 16 Dec 2024 According to LIB Therapeutics media release, company announced the submission of a Biologics License Application to the U.S. Food and Drug Administration seeking approval of Lerodalcibep to reduce low-density lipoprotein cholesterol (LDL-C) for the treatment of patients with atherosclerotic cardiovascular disease (ASCVD), or very high or high risk of ASCVD, and primary hyperlipidemia, including heterozygous and homozygous familial hypercholesterolemia based on Phase 3 LIBerate studies
  • 16 Dec 2024 According to LIB Therapeutics media release, company announced that as the BLA has been submitted to the FDA, and is now preparing a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for submission by mid-2025
  • 18 Nov 2024 According to a LIB Therapeutics media release, data from the study were presented as late-breaking oral presentations at Featured Science: Novel Approaches to Managing Lipid Risk Session at American Heart Association 2024 in Chicago, Illinois on November 16.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top