Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07102511 · ClinicalTrials.gov registry record · Phase 3
Randomized, Placebo-Controlled, Double-Blind, Phase 3b Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH
A Phase 3 study, sponsored by LIB Therapeutics.
- Not yet
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
NCT07102511 is a Phase 3 study that has not yet begun recruiting, run by LIB Therapeutics. The registered enrollment target is 150 participants.
The verdict
NCT07102511, a Phase 3 study, has not yet begun recruiting, sponsored by LIB Therapeutics.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to assess the LDL-Cholesterol reductions at Week 12 and Week 24 with monthly dosing of lerodalcibep (Lerochol) 300 mg administered subcutaneously by auto-injector (AI)/pre-filled pen (PFP) compared to placebo (dummy), in male and female pediatric patients 6 to 17 years of age, with inherited high cholesterol (HeFH) on a stable diet and maximally tolerated oral LDL C lowering drug therapy such as statins. The main question\[s\] it aims to answer are: How effective is Lerochol in reducing LDL cholesterol? How well is it tolerated and are there any safety concerns? Researchers will compare Lerochol to placebo (inert or dummy injection solution). Participants will visit the clinic every month for months and be asked to fast overnight, but allowed to drink water, before clinic visits. Undergo physical exams, height and weight measurements, answer questions, have blood drawn from a vein in their arm, have blood pressure measurements, EKC heart tests, and receive monthly injections lasting about 5 seconds in their arms or abdomen with an autoinjector.
Interventions
- BIOLOGICAL lerodalcibep 300 mg Monthly SC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-09-01 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07102511
The ClinicalTrials.gov registry entry for NCT07102511 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 150 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 1 intervention - of which lerodalcibep 300 mg Monthly SC is the first listed.
NCT07102511 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07102511 about?
NCT07102511 is a clinical study titled "Randomized, Placebo-Controlled, Double-Blind, Phase 3b Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH". The goal of this clinical trial is to assess the LDL-Cholesterol reductions at Week 12 and Week 24 with monthly dosing of lerodalcibep (Lerochol) 300 mg administered subcutaneously by auto-injector (AI)/pre-filled pen (PFP) compared to placebo (dummy), in male and female pediatric patients 6 to 17 y...
What is the current status of trial NCT07102511?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2025-09-01. Estimated completion is 2027-06-30.
What interventions are being tested in trial NCT07102511?
The interventions under investigation include: lerodalcibep 300 mg Monthly SC (BIOLOGICAL).
Who is sponsoring clinical trial NCT07102511?
This trial is sponsored by LIB Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.