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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
Must not have
Uncontrolled thyroid disease: hyperthyroidism or hypothyroidism
Documented history of HoFH defined clinically or genetically
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 50 and 52 weeks
Awards & highlights
Pivotal Trial

Summary

This trial tests an injectable drug called LIB003 to lower bad cholesterol in patients with or at high risk for heart disease. The study will compare the effects of LIB003 over a period of time. Patients are already on a stable diet and taking other cholesterol-lowering medications.

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.
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.
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.

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.
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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.
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I have a history of heart or blood vessel disease, or I'm at high/very high risk for it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My thyroid condition is not under control.
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I have been diagnosed with HoFH either through symptoms or genetic testing.
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I do not have active liver disease, a liver transplant history, or high liver enzyme levels.
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I haven't had major heart issues or strokes in the last 3 months.
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I have severe heart failure.
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My diabetes is not under control, with high blood sugar or HbA1C levels.
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My kidney function is low, with an eGFR under 30.
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I am scheduled for heart surgery or a procedure to improve blood flow.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
LDL-C change compared to placebo
mean LDL-C change at week 50 and 52
Secondary study objectives
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~940

Find a Location

Who is running the clinical trial?

LIB Therapeutics LLCLead Sponsor
10 Previous Clinical Trials
4,011 Total Patients Enrolled
Medpace, Inc.Industry Sponsor
96 Previous Clinical Trials
28,977 Total Patients Enrolled
Evan A Stein, MD PhDStudy DirectorLIB Therapeutics
5 Previous Clinical Trials
1,367 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
~200 spots leftby Nov 2025
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