Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study to Assess the Efficacy and Safety of LIB003 in HeFH Patients on Oral Lipid Therapy Needing Further LDL-C Reduction
NCT04797104 · View on ClinicalTrials.gov ↗
Study Summary
This study is to assess LDL-C reductions at Week 24 and the mean of Weeks 22 and 24 with monthly Q4W (≤31 days) dosing of LIB003 300 mg administered subcutaneously (SC) compared to placebo in patients 18 years or older with Heterozygous FH on stable diet and oral LDL-C lowering drug therapy.
Conditions Studied
Interventions
- DRUG lerodalcibep
Study Locations (7)
Other
- Department of Medicine, Hadassah University Hospital — Jerusalem
- Rabin Medical Center, Beilinson Hospital, — Petah Tikva
- Lipid Clinic, Oslo University Hospital — Oslo
Ohio
- Metabolic & Atherosclerosis Research Center (MARC) — Cincinnati
Gauteng
- Carbohydrate and Lipid Metabolism Research Unit — Johannesburg
Western Province
- Division of Lipidology, Department of Medicine University of Cape Town — Cape Town
Bornova
- Ege University Medical School — Izmir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 478 participants |
| Start Date | 2021-04-22 |
| Est. Completion | 2023-12-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04797104
The ClinicalTrials.gov registry entry for NCT04797104 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 478 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is LIB Therapeutics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Heterozygous Familial Hypercholesterolemia appearing as the primary indexed condition, and to 1 intervention — of which lerodalcibep is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04797104 reports 7 study locations spanning 5 distinct geographic areas — top geographies include Other, Ohio, Gauteng. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04797104 about?
NCT04797104 is a clinical study titled "Study to Assess the Efficacy and Safety of LIB003 in HeFH Patients on Oral Lipid Therapy Needing Further LDL-C Reduction". This study is to assess LDL-C reductions at Week 24 and the mean of Weeks 22 and 24 with monthly Q4W (≤31 days) dosing of LIB003 300 mg administered subcutaneously (SC) compared to placebo in patients 18 years or older with Heterozygous FH on stable diet and oral LDL-C lowering drug therapy.
What is the current status of trial NCT04797104?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 478 participants. The study started on 2021-04-22. Estimated completion is 2023-12-05.
What conditions does trial NCT04797104 study?
This clinical trial studies the following conditions: Heterozygous Familial Hypercholesterolemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04797104?
The interventions under investigation include: lerodalcibep (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04797104?
This trial is sponsored by LIB Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04797104 being conducted?
This trial has 7 study locations across Ohio, Gauteng, Western Province, Bornova. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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