Pharmaceutical company conducts a Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction

Th company LIB Therapeutics LLC in collaboration with Medpace, Inc. is recruiting patients for the clinical trial of Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction (LIBerate-HR).

This study is to assess LDL-C reductions at Week 52 with monthly (Q4W [≤31 days]) dosing of LIB003 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with CVD, or at high risk for CVD, on a stable diet and oral LDL-C lowering drug therapy.

Participants who fulfill the inclusion and exclusion criteria will be enrolled at up to 65 sites in the United States, Canada, Europe, South Africa, Asia, Australasia, and the Middle East.

The study will take place at the Sterling Research Group, Cincinnati, Ohio; The Lindner Research Center, Cincinnati, Ohio; Metabolic & Atherosclerosis Research Center (MARC), Cincinnati, Ohio, United States; G.B. Pant Institute of Postgraduate Medical Education & Research, New Delhi, India; Department of Medicine, Hadassah University Hospital, Jerusalem and Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel.

The researchers plan that April 16, 2021 will be the study start date. The indicative completion of the clinical trial will be expected in December 31, 2022.

Among the criteria that allow participation, the following are indicated:

  • Weight of ≥40 kg (88 lb) and body mass index (BMI) ≥17 and ≤42 kg/m2;
  • History of CVD, (including cerebrovascular or peripheral arterial disease) or very-high risk for CVD as defined in the 2019 ESC/EAS Guidelines or
  • High risk for CVD as defined in the 2019 ESC/EAS Guidelines
  • At Screening or post Washout/Stabilization, LDL-C ≥70 mg/dL and TG ≤400 mg/dL while on stable lipid-lowering oral drug therapy (i.e., maximally tolerated statin with or without ezetimibe); Patients unable to tolerate approved doses of a statin may take lower than approved doses and dose less frequently than daily as long as the dose and dosing frequency is consistent; Patients with documentation of inability to tolerate any statin at any dose, or history of rhabdomyolysis, may also participate;
  • Stable diet and lipid-lowering oral therapies (such as statins, ezetimibe, bile-acid sequestrants, OM-3 compounds, fenofibrate, bezafibrate, nicotinic acid, and bempedoic acid) or combinations thereof for at least 4 weeks

The full list can be viewed at the link below.

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04806893

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