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NCT04034485 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH
A Phase 3 study, sponsored by LIB Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 65
- Enrollment target
NCT04034485 is a Phase 3 study that has completed, run by LIB Therapeutics. The registered enrollment target is 65 participants.
The verdict
NCT04034485, a Phase 3 study, has completed, sponsored by LIB Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 65 participants
- Enrollment target
Study Summary
To compare the safety, tolerability and LDL-C response after 24 Weeks of monthly (every 4 weeks \[Q4W\]) subcutaneous (SC) dosing of LIB003 300 mg with monthly (Q4W) SC dosing of 420 mg evolocumab (Repatha®) in patients with HoFH on stable diet and oral LDL-C-lowering drug therapy
Interventions
- DRUG lerodalcibep
- DRUG evolocumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2019-12-07 |
| Est. Completion | 2023-01-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04034485
The ClinicalTrials.gov registry entry for NCT04034485 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is LIB Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which lerodalcibep is the first listed.
NCT04034485 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04034485 about?
NCT04034485 is a clinical study titled "Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH". To compare the safety, tolerability and LDL-C response after 24 Weeks of monthly (every 4 weeks \[Q4W\]) subcutaneous (SC) dosing of LIB003 300 mg with monthly (Q4W) SC dosing of 420 mg evolocumab (Repatha®) in patients with HoFH on stable diet and oral LDL-C-lowering drug therapy
What is the current status of trial NCT04034485?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2019-12-07. Estimated completion is 2023-01-30.
What interventions are being tested in trial NCT04034485?
The interventions under investigation include: lerodalcibep (DRUG), evolocumab (DRUG).
Who is sponsoring clinical trial NCT04034485?
This trial is sponsored by LIB Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
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