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Monoclonal Antibodies

Lerodalcibep for Cardiovascular Risk (LIBerate-HR Trial)

Phase 3
Waitlist Available
Research Sponsored by LIB Therapeutics LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients on a PCSK9 mAb at a dose of 75 mg, 140 mg, or 150 mg Q2W must undergo a washout period of ≥4 weeks after the last dose; for those on 300 mg or 420 mg Q4W (≤31 days) the washout period is ≥8 weeks following last dose
At Screening or post Washout/Stabilization, LDL-C ≥70 mg/dL and TG ≤400 mg/dL while on stable lipid-lowering oral drug therapy (i.e., maximally tolerated statin with or without ezetimibe); Patients unable to tolerate approved doses of a statin may take lower than approved doses and dose less frequently than daily as long as the dose and dosing frequency is consistent; Patients with documentation of inability to tolerate any statin at any dose, or history of rhabdomyolysis, may also participate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 50 and 52 weeks
Awards & highlights

LIBerate-HR Trial Summary

This trial is to see if a new drug, given monthly, can lower LDL-C levels compared to placebo in patients with CVD or at high risk for CVD.

Who is the study for?
This trial is for adults with cardiovascular disease (CVD) or at high risk for CVD who need further reduction in bad cholesterol (LDL-C). They must be on a stable diet and oral cholesterol-lowering medications, weigh at least 88 pounds, have a BMI between 17-42, and if female and able to bear children, use effective birth control. Exclusions include recent serious heart events, liver disease, uncontrolled diabetes or thyroid disease.Check my eligibility
What is being tested?
The study tests the effectiveness of lerodalcibep (LIB003), given as a monthly shot under the skin compared to placebo. It aims to see how well it lowers LDL-C after one year in patients already taking other cholesterol drugs. Participants are chosen randomly to receive either lerodalcibep or placebo.See study design
What are the potential side effects?
Potential side effects of lerodalcibep may include reactions at the injection site such as pain or swelling, general discomfort like fatigue or headaches, possible digestive issues and allergic reactions. The exact side effects will be monitored throughout the trial.

LIBerate-HR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have stopped my PCSK9 inhibitor medication for at least 4 or 8 weeks, depending on the dose.
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My LDL cholesterol is 70 mg/dL or higher, and my triglycerides are 400 mg/dL or lower while on stable cholesterol medication.
Select...
I weigh at least 88 pounds and my BMI is between 17 and 42.
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I am using effective birth control and my pregnancy test was negative.
Select...
I have a history of heart or blood vessel disease, or I'm at high/very high risk for it.

LIBerate-HR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~50 and 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 50 and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
LDL-C change compared to placebo
mean LDL-C change at week 50 and 52
Secondary outcome measures
Change in Free PCSK9
Incidence of Treatment-Emergent Adverse Events as assessed by Medical Dictionary for Regulatory Activities as severe, moderate or mild after 52 weeks
Percentage of patients achieving 2019 ESC/EAS LDL-C goals

LIBerate-HR Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LIB003 (lerodalcibep)Experimental Treatment1 Intervention
300 mg subcutaneously monthly (Q4W)
Group II: PlaceboPlacebo Group1 Intervention
matching placebo subcutaneously monthly (Q4W)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
lerodalcibep
2022
Completed Phase 3
~770

Find a Location

Who is running the clinical trial?

LIB Therapeutics LLCLead Sponsor
10 Previous Clinical Trials
4,005 Total Patients Enrolled
Medpace, Inc.Industry Sponsor
94 Previous Clinical Trials
28,715 Total Patients Enrolled
Evan A Stein, MD PhDStudy DirectorLIB Therapeutics
5 Previous Clinical Trials
1,361 Total Patients Enrolled

Media Library

Lerodalcibep (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04806893 — Phase 3
High Cholesterol Research Study Groups: LIB003 (lerodalcibep), Placebo
High Cholesterol Clinical Trial 2023: Lerodalcibep Highlights & Side Effects. Trial Name: NCT04806893 — Phase 3
Lerodalcibep (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04806893 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people with the required qualifications needed for this research project currently being accepted?

"The clinical trial in question is no longer recruiting patients, as can be seen from the information available on clinicaltrials.gov. This study was first posted on April 22nd, 2021 and was last updated on November 3rd, 2022. There are 882 other trials that are still recruiting patients."

Answered by AI

Are there any lerodalcibep side effects that patients should be aware of?

"There is some evidence from Phase 3 clinical trials that lerodalcibep is efficacious and safe."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction
2021. "Study of Long-Term Efficacy and Safety of LIB003 in CVD or High Risk for CVD Patients Needing Further LDL-C Reduction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04806893.
~225 spots leftby Apr 2025
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