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NCT04797104 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy and Safety of LIB003 in HeFH Patients on Oral Lipid Therapy Needing Further LDL-C Reduction
A Phase 3 study of Heterozygous Familial Hypercholesterolemia, sponsored by LIB Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 478
- Enrollment target
- 7
- Study locations
NCT04797104: Completed Phase 3 study of Heterozygous Familial Hypercholesterolemia, sponsored by LIB Therapeutics.
NCT04797104 is a Phase 3 study of Heterozygous Familial Hypercholesterolemia that has completed, run by LIB Therapeutics. The registered enrollment target is 478 participants, above the 144-participant average among 4 other Heterozygous Familial Hypercholesterolemia trials with a reported enrollment target (232% higher). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04797104, a Phase 3 study of Heterozygous Familial Hypercholesterolemia, has completed, sponsored by LIB Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 478 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
LS mean percent change in LDL-cholesterol compared to placebo
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 |
What the finished NCT04797104 record still lists
NCT04797104 is an interventional study that assigns participants to a tested intervention. The registered 478 participants enrollment target is mid-sized for trials with a published cap, above the 144-participant average among 4 other Heterozygous Familial Hypercholesterolemia trials with a reported enrollment target (232% higher).
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.
NCT04797104 lists 7 locations in 5 states (Other, Ohio, Gauteng).
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.
What interventions are being tested in trial NCT04797104?
The interventions under investigation include: lerodalcibep (DRUG).
Who is sponsoring clinical trial NCT04797104?
This trial is sponsored by LIB Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
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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