Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C Reduction

Part of paid clinical trials in Evanston, Illinois.

Sponsor
LIB Therapeutics LLC
Study ID
NCT04798430
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lerodalcibep — DRUG
    PCSK9 inhibitor

Study Details

The study is to assess the long-term safety, tolerability, and efficacy after 48 and 72 weeks with monthly (Q4W \[\<31 days\]) dosing of subcutaneous (SC) LIB003 300 mg administered in patients with CVD or at high risk for CVD (including HoFH and HeFH) on stable diet and oral LDL-C lowering drug therapy who completed one of the LIB003 Phase 3 base studies.

Key Dates

Start date
Dec 3, 2020
Status verified
Oct 2024
Primary completion
Jul 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
2,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LIB003 (lerodalcibep)
    300 mg monthly (Q4W) by subcutaneous injection

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 48 and 72 weeks [ Time Frame: 72 weeks ]

Locations (4)

FacilityCityStateZIPSite coordinators
NorthShore University Health SystemEvanstonIllinois60201-
Metabolic & Atherosclerosis Research Center (MARC)CincinnatiOhio45227-
Sterling Research GroupCincinnatiOhio45219-
The Lindner Research CenterCincinnatiOhio45219-

Find similar trials in Evanston, IL

By research site
NorthShore University Health System· Evanston, ILMetabolic & Atherosclerosis Research Center (MARC)· Cincinnati, OHSterling Research Group· Cincinnati, OHThe Lindner Research Center· Cincinnati, OH

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