Study of Efficacy and Safety of LIB003 in Patient With CVD on Statins Requiring Additional LDL-C Reduction

NCT04797247 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: LIB003-005
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 3

Brief Summary

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 very-high risk for CVD on a stable diet and oral LDL-C lowering drug therapy.

Conditions

Cardiovascular Diseases; Hyper-LDL-cholesterolemia

Keywords

lerodalcibep; PCSK9 inhibitor

Outcome Measures

Primary Outcomes (2)

• LDL-C change compared to placebo

  Percent change in LS mean from baseline compared to placebo in LDL-C level

  52 weeks

• mean LDL-C change at week 50 and 52

  Percent change in LS mean from baseline compared to placebo in LDL-C level at Weeks 50 and 52

  52 weeks

Secondary Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 52 weeks

  52 weeks

• Free PCSK9 change

  52 weeks

• Percentage of patients achieving 2019 ESC/EAS LDL-C goals

  52 weeks

Study Arms (2)

LIB003 (lerodalcibep)

EXPERIMENTAL

300 mg subcutaneously monthly (Q4W)

Drug: lerodalcibep

Placebo

PLACEBO COMPARATOR

matching placebo subcutaneously monthly (Q4W)

Drug: lerodalcibep

Interventions

lerodalcibep DRUG

PCSK9 inhibitor

Also known as: LIB003

LIB003 (lerodalcibep); Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written and signed informed consent prior to any study-specific procedure;
• Male or female ≥18 years of age at the first Screening Visit;
• Weight of ≥40 kg (88 lb) and body mass index (BMI) ≥17 and ≤42 kg/m2;
• At very high risk for CVD which includes history of CVD, (including cerebrovascular or peripheral arterial disease) or very high risk as defined in the 2019 ESC/EAS Guidelines
• At Screening or post Washout/Stabilization), ≥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;
• On a 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
• Patients on a PCSK9 mAb at a dose of 75 mg, 140 mg, or 150 mg Q2W must undergo a washout period of ≥4 weeks after the last dose; for those on 300 mg or 420 mg Q4W (≤31 days) the washout period is ≥8 weeks following last dose; 8. Females of childbearing potential must be using a highly effective form of birth control if sexually active and have a negative urine pregnancy test at the last Screening Visit;

You may not qualify if:

• Use of prohibited oral lipid-lowering agents mipomersen or lomitapide within 6 months of screening, gemfibrozil within 6 weeks of screening, LDL or plasma apheresis within 2 months prior to randomization; received other investigational agent(s) such as PCSK9 or Lp(a) siRNA or locked nucleic acid-reducing agents within 12 months of the Screening Visit;
• Documented history of HoFH defined clinically or genetically
• Females of childbearing potential who are sexually active, not using or unwilling to use a highly effective form of contraception, pregnant or breastfeeding, or who have a positive urine pregnancy test at the last Screening Visit;
• Moderate to severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73m2
• Active liver disease or hepatic dysfunction, history of liver transplant, and/or ALT or AST \>2.5 × the ULN as determined by central laboratory analysis at screening
• Uncontrolled thyroid disease: hyperthyroidism or hypothyroidism 9. Uncontrolled Type 1 or Type 2 DM, defined as FBS ≥200 mg/dL or HbA1C ≥9%; 10. Uncontrolled serious cardiac arrhythmia, MI, unstable angina, PCI, CABG, placement of implantable cardioverter defibrillator or biventricular pacemaker, aortic valve surgery, or stroke within 3 months prior to the Screening Visit; 11. Planned cardiac surgery or revascularization; 12. New York Heart Association class III-IV heart failure

Sponsors & Collaborators

• LIB Therapeutics LLC: lead
• Medpace, Inc.: collaborator

Study Sites (3)

Sterling Research Group

Cincinnati, Ohio, 45219, United States

Location

The Lindner Research Center

Cincinnati, Ohio, 45219, United States

Location

Metabolic & Atherosclerosis Research Center (MARC)

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Evan A Stein, MD PhD

  LIB Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: participants, study staff, investigator and sponsor blinded to treatment and lipid levels
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double blind, placebo controlled

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 15, 2021
• Study Start: April 22, 2021
• Primary Completion: November 15, 2023
• Study Completion: February 28, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)