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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: Completed Phase 3 study, sponsored by LIB Therapeutics.
NCT04034485 is a Phase 3 study that has completed, run by LIB Therapeutics. The registered enrollment target is 65 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Change in serum LDL-C from baseline after 24 weeks
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 |
What the finished NCT04034485 record still lists
NCT04034485 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which lerodalcibep is the first listed.
NCT04034485 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04034485's enrollment target sits among peer trials
65 1797th of 2000 higher than 202 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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