NCT04798430

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

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: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: LIB Therapeutics LLC · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The population for this open-label study includes patients who successfully complete one of the randomized, controlled (placebo or comparator) blinded Phase 3 base studies (LIB003-003, LIB003-004, LIB003-005, LIB003-006, LIB003-008, LIB003-011 and LIB003-012). Patients will continue to maintain their existing oral lipid-lowering therapy (LLT). Following completion of a base study and providing informed consent, patients will receive doses of LIB003 300 mg Q4W (\<31 days) on Day 1 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, and 68. Patients will be seen in the clinic Q4W (\<31 days) for at least the initial 12 weeks and then every 12 weeks (Weeks 24, 36, 48, 60, and 72) with the interim Q4W (\<31 days) doses administered at home. Patients may begin the OLE on the final visit of their prior study after completion of all requirements for that trial. Their lipids will remain blinded (to patient, study staff and sponsor) until week 4 to avoid any unblinding of the prior trial. Thereafter lipid results will be unblinded throughout the remainder of the 72 week trial.

Conditions

• Cardiovascular Disease With Mention of Arteriosclerosis
• Elevated Cholesterol
• Familial Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	lerodalcibep	PCSK9 inhibitor

Timeline

• Start date: 2020-12-03
• Primary completion: 2025-07-30
• Completion: 2025-12-31
• First posted: 2021-03-15
• Last updated: 2024-10-22

Locations

12 sites across 6 countries: United States, India, Israel, Norway, South Africa, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study