Familial Hypercholesterolemia - HeterozygousPhase 3LIBerateKidsNCT07102511
Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children 6 to 17 Years, With Heterozygous FH
A Phase 3 study testing lerodalcibep 300 mg Monthly SC in people with Familial Hypercholesterolemia - Heterozygous, run by LIB Therapeutics LLC at 7 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Familial Hypercholesterolemia - Heterozygous
- What is being tested?
- lerodalcibep 300 mg Monthly SC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 7 sitesin 6 countries
- Study dates
- 20 Jul 2026to 30 Nov 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Provision of written and signed informed consent/assent prior to any study-specific procedure;
- Male or female, 6 to 17 years of age (defined as from 6 to less than 18 years of age), at the first Screening Visit;
- Weight of more than 18 kg (40 lbs) and BMI more than 17 and less than42 kg/m2;
- Diagnosis of definite, probable, or possible HeFH based on clinical criteria (SB Register criteria or genotyping and at the defined eligibility visit (Screening Visit or post washout/stabilization); a calculated LDL-C (Friedewald) equal or above 130 mg/dL and TG below 400 mg/dL while on stable lipid-lowering oral drug therapy (eg, maximally tolerated statin with or without ezetimibe); Note: Patients unable to tolerate approved doses of a statin may take lower than approved doses and less frequently than daily as long as the dose and dosing frequency is consistent per the Investigator's judgment. Patients with documented intolerance to statins may also participate;
- On a stable diet and lipid-lowering oral therapies (statins, ezetimibe, bile-acid sequestrants) or combinations thereof for at least 6 weeks (excluded oral lipid-lowering agents include mipomersen, lomitapide, and gemfibrozil);
- Patients on a PCSK9 mAb must undergo a washout period of >8 weeks after the last dose. For patients who have received an siRNA PCSK9 inhibitor the washout period is 360 days post last dose;
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- Females of childbearing potential must be using a highly effective form of contraception if sexually active and have negative urine pregnancy test at the last Screening Visit; Note: Highly effective methods of birth control include refraining from heterosexual sexual intercourse during the entire period of risk, birth control pills or patches, intrauterine devices (IUDs), sexual activity with a male partner who has had a vasectomy, condom or diaphragm or cervical cap with spermicide or IUD, oral, implantable, or injectable contraceptives.
- Male patients will either be surgically sterile or agree to use the following forms of contraception: male or female condom with spermicide and a female partner who is sterile or who agrees to use the following contraceptives: diaphragm or cervical cap with spermicide; or IUD, oral, implantable, or injectable contraceptives; and
- Male patients must refrain from sperm donation until 90 days following the last dose of study drug.
Who cannot join
- Use of prohibited oral lipid-lowering agents mipomersen or lomitapide within 6 months of screening or gemfibrozil within 6 weeks of the Screening Visit;
- LDL or plasma apheresis within 2 months prior to Day 1;
- Documented history of HoFH defined as clinical and/or genetic with true HoFH (ie, identical pathogenic variants), compound heterozygous (ie, 2 different pathogenic LDLR variants) or combined heterozygous (2 different pathogenic FH variants such as LDLR plus ApoB or LDLR plus PCSK9 gain-of function);
- History of any prior or active clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator, including but not limited to clinically significant pulmonary, hematologic, gastrointestinal, endocrine (excluding diabetes), immunologic, dermatologic, neurologic, or psychiatric disease, which in the Investigator's opinion, would not be suitable for the study from a patient safety consideration or could interfere with the results of the study;
- Females of childbearing potential who are sexually active, not using or unwilling to use a highly effective form of contraception, pregnant or breastfeeding, or who have a positive urine pregnancy test at the last Screening Visit; Note: Highly effective methods of birth control include refraining from heterosexual sexual intercourse during the entire period of risk, birth control pills or patches, IUDs, sexual activity with a male partner who has had a vasectomy, condom or diaphragm or cervical cap with spermicide or IUD, oral, implantable, or injectable contraceptives.
- Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate <30 mL/min/1.73m2 at the Screening Visit;
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- Active liver disease or hepatic dysfunction (eg, cirrhosis, alcoholic liver disease, known hepatitis B or hepatitis C, autoimmune hepatitis, liver failure, liver cancer), history of liver transplant, and/or AST or ALT >2.5 × the ULN based on age as determined by central laboratory analysis at screening (tests that result in ALT or AST up to 3 × ULN may have 1 repeat test to confirm eligibility during the Screening Period);
- Uncontrolled thyroid disease: hyperthyroidism or hypothyroidism as defined by thyroid stimulating hormone (TSH) below the lower limit of normal (LLN) or >1.5 × ULN, respectively, at the Screening Visit. If TSH is above/below these cut-off points, the patient can enter if the free triiodothyronine (FT3) is within the reference range. If controlled, then treatment should be stable for at least 3 months prior to the Screening Visit;
- Uncontrolled Type 1 or Type 2 diabetes mellitus (defined as fasting glucose above 200 mg/dL and HbA1c of above 9%);
- Uncontrolled serious cardiac arrhythmia (sustained ventricular tachycardia, frequent non sustained ventricular tachycardia, any ventricular fibrillation episode, wide-complex tachycardia, atrial fibrillation with rapid ventricular response, and severe second-degree or third degree atrioventricular block), myocardial infarction (MI), unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, placement of implantable cardioverter defibrillator or biventricular pacemaker, aortic valve surgery, or stroke within 3 months prior to enrollment (the day patient signs the informed consent/assent and first procedure is performed);
- Planned cardiac surgery or revascularization;
- New York Heart Association III-IV heart failure; or patients with last documented left ventricular ejection fraction <30% by standard of care assessments (eg, echocardiography, cardiac magnetic resonance imaging, nuclear imaging, computed tomography angiography, or angiography with ventriculogram), within 12 months;
- Uncontrolled hypertension defined as a reproducible (ie, repeated 5 minutes apart) sitting blood pressure above 160 mmHg systolic or above 100 mmHg diastolic;
- Enrolled in another investigational device or drug study, or less than 30 days or 5 half-lives since ending another investigational device or drug study(ies), or receiving other investigational agent(s); such as PCSK9 or ANGPTL3 or Lp(a) siRNA or locked nucleic acid reducing agents within 12 months of the Screening Visit;
- Unexplained CK >5 × ULN, unless related to exercise or unusual activity in which case 1 repeat test is allowed;
- Patients who cannot be available for Protocol-required study visits or procedures, to the best of the patient's and Investigator's knowledge;
- A history, within 6 months prior to screening, of prescription drug abuse, illicit drug use, or alcohol abuse according to medical history;
- Donated or lost a significant volume (>500 mL) of blood or plasma within 30 days prior to Day 1;
- Had a blood transfusion within 4 weeks of randomization or known diagnosis of human immunodeficiency virus;
- Previous treatment with lerodalcibep or any adnectin product;
- Have any other finding which, in the opinion of the Investigator, would compromise the patient's safety or participation in the study; or
- An employee or family member of the Investigator or study site personnel.
Trial locations and contacts
7 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 6 countries
South Africa2 sites
Iatros International
Bloemfontein, Free State
Lipid Clinic Wits University
Johannesburg, Gauteng, 2193
United States1 site
Metabolic & Atherosclerosis Research Center
Cincinnati, Ohio, 45227
About this study
Official title: Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children and Adolescents, 6 to 17 Years of Age, With Heterozygous Familial Hypercholesterolemia on Stable Diet and Oral Lipid-Lowering Therapy (LIBerate-Kids)
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:
Read more
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.
Read the detailed description
This is a randomized, placebo-controlled, double-blind, Phase 3b study to evaluate the efficacy, safety, and tolerability of lerodalcibep 300 mg administered SC QM over a 24-week Treatment Period. Approximately 150 males and females, 6 to 17 years of age, with HeFH and who fulfill the inclusion and exclusion criteria will be enrolled at approximately 30 sites in the United States, Canada, Central and South America, Europe, South Africa, Asia, Australasia, and the Middle East. Patients will be randomized in a 2:1 ratio to lerodalcibep 300 mg (100 patients) or placebo (50 patients) administered SC QM. The study will consist of a Screening Period and a Treatment Period. The total study duration will be up to 35 weeks which includes up to an 11-week Screening Period (which may include up to an 8 week washout) and 24 weeks of study drug treatment
Following randomization and dosing on Day 1, patients will be seen in the clinic QM for 20 weeks and then at 2 week intervals for Weeks 22 and 24. All patients will receive doses of lerodalcibep 300 mg QM or placebo on Day 1 and Weeks 4, 8, 12, 16, and 20.
OBJECTIVES:
The co-primary objectives of this study are to assess the LDL-C reductions at Week 12 and Week 24 with monthly dosing of lerodalcibep 300 mg compared to placebo, in pediatric patients 6 to 17 years of age, with HeFH on a stable diet and maximally tolerated oral LDL C lowering drug therapy.
The secondary objectives of this study are the following:
- To assess the LDL-C-lowering effects of lerodalcibep with LDL-C calculated by Friedewald formula compared to placebo at Week 22 and the mean of Weeks 22 and 24;
- To assess the change in LDL-C, measured by preparative ultracentrifugation (PUC), from baseline (Week 0) with lerodalcibep compared to placebo at Week 24;
- To assess safety and tolerability of lerodalcibep in pediatric patients with HeFH;
- To assess the pharmacodynamic (PD) effects of 300 mg lerodalcibep QM on serum unbound (free) PCSK9 concentrations at Weeks 22 and 24;
- To assess the effects of lerodalcibep on serum lipids, including total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), non-HDL-C, very low-density lipoprotein cholesterol (VLDL-C), and triglycerides (TG);
- To assess the effects of lerodalcibep on ApoB and lipoprotein (a) (Lp[a]) serum concentrations compared to placebo at Weeks 12, 22, and 24, and the mean of Weeks 22 and 24;
- To assess the pharmacokinetics (PK) of lerodalcibep and total PCSK9 following 300 mg QM SC doses of lerodalcibep at Weeks 22 (peak post-dose) and 24 (trough post-dose); and
- To assess the frequency and level of anti-drug antibodies (ADAs) (immunogenicity) following multiple SC doses of lerodalcibep.
The exploratory objectives of this study are the following:
- To assess the LDL-C response based on underlying genetic variants associated with HeFH;
- To assess percentage of patients achieving current pediatric guidelines;
- To assess the effects on other lipid and cardiovascular risk biomarkers as appropriate;
- To assess the effects on physical development and endocrine tests as appropriate for age and sex; and
- To assess change from baseline in carotid intima-media thickness compared to placebo in children who do not tolerate statins, or have LDL-C levels >130 mg/dL despite >6 weeks, but <6 months, of statin treatment.
- Being tested
- lerodalcibep 300 mg Monthly SC
- Keywords
- inherited high cholesterol, high cholesterol
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lerodalcibep 300 mg Monthly SCBiological
Also called placebo monthly SC
lerodalcibep or placebo
| Study group | Role | What they receive |
|---|---|---|
| Lerodalcibep | Active comparator | 300 mg SC QM Receives: Biological: lerodalcibep 300 mg Monthly SC |
| Placebo | Placebo comparator | SC QM Receives: Biological: lerodalcibep 300 mg Monthly SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Density Lipoprotein cholesterol at week 12
Change in LDL-C at week 12 relative to that of placebo
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start20 Jul 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Hypercholesterolemia - HeterozygousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized placebo controlled parallel trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LIB Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
- Investigators
- David Kallend, MB BS, Study director, Chief Medical Officer, LIB Therapeutics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102511
- Sponsor's protocol ID
- LIB003-008
- Other IDs
- 2025-524214-28-00, 2025
- Acronym
- LIBerateKids
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Efficacy and Safety of Lerodalcibep in Children and Adolescents, 6 to 17 Years of Age, With Heterozygous Familial Hypercholesterolemia on Stable Diet and Oral Lipid-Lowering Therapy (LIBerate-Kids)
- ClinicalTrials.gov ID
- NCT07102511
- Acronym / sponsor ID
- LIBerateKids / LIB003-008
- Keywords
- inherited high cholesterol, high cholesterol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- LIB Therapeutics LLCIndustry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, placebo-controlled, double-blind, Phase 3b study to evaluate the efficacy, safety, and tolerability of lerodalcibep 300 mg administered SC QM over a 24-week Treatment Period. Approximately 150 males and females, 6 to 17 years of age, with HeFH and who fulfill the inclusion and exclusion criteria will be enrolled at approximately 30 sites in the United States, Canada, Central and South America, Europe, South Africa, Asia, Australasia, and the Middle East. Patients will be randomized in a 2:1 ratio to lerodalcibep 300 mg (100 patients) or placebo (50 patients) administered SC QM. The study will consist of a Screening Period and a Treatment Period. The total study duration will be up to 35 weeks which includes up to an 11-week Screening Period (which may include up to an 8 week washout) and 24 weeks of study drug treatment
Following randomization and dosing on Day 1, patients will be seen in the clinic QM for 20 weeks and then at 2 week intervals for Weeks 22 and 24. All patients will receive doses of lerodalcibep 300 mg QM or placebo on Day 1 and Weeks 4, 8, 12, 16, and 20.
OBJECTIVES:
The co-primary objectives of this study are to assess the LDL-C reductions at Week 12 and Week 24 with monthly dosing of lerodalcibep 300 mg compared to placebo, in pediatric patients 6 to 17 years of age, with HeFH on a stable diet and maximally tolerated oral LDL C lowering drug therapy.
The secondary objectives of this study are the following:
- To assess the LDL-C-lowering effects of lerodalcibep with LDL-C calculated by Friedewald formula compared to placebo at Week 22 and the mean of Weeks 22 and 24;
- To assess the change in LDL-C, measured by preparative ultracentrifugation (PUC), from baseline (Week 0) with lerodalcibep compared to placebo at Week 24;
- To assess safety and tolerability of lerodalcibep in pediatric patients with HeFH;
- To assess the pharmacodynamic (PD) effects of 300 mg lerodalcibep QM on serum unbound (free) PCSK9 concentrations at Weeks 22 and 24;
- To assess the effects of lerodalcibep on serum lipids, including total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), non-HDL-C, very low-density lipoprotein cholesterol (VLDL-C), and triglycerides (TG);
- To assess the effects of lerodalcibep on ApoB and lipoprotein (a) (Lp[a]) serum concentrations compared to placebo at Weeks 12, 22, and 24, and the mean of Weeks 22 and 24;
- To assess the pharmacokinetics (PK) of lerodalcibep and total PCSK9 following 300 mg QM SC doses of lerodalcibep at Weeks 22 (peak post-dose) and 24 (trough post-dose); and
- To assess the frequency and level of anti-drug antibodies (ADAs) (immunogenicity) following multiple SC doses of lerodalcibep.
The exploratory objectives of this study are the following:
- To assess the LDL-C response based on underlying genetic variants associated with HeFH;
- To assess percentage of patients achieving current pediatric guidelines;
- To assess the effects on other lipid and cardiovascular risk biomarkers as appropriate;
- To assess the effects on physical development and endocrine tests as appropriate for age and sex; and
- To assess change from baseline in carotid intima-media thickness compared to placebo in children who do not tolerate statins, or have LDL-C levels >130 mg/dL despite >6 weeks, but <6 months, of statin treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized placebo controlled parallel trial
| Arm | Type | Receives |
|---|---|---|
| Lerodalcibep | Active comparator | Biological: lerodalcibep 300 mg Monthly SC300 mg SC QM |
| Placebo | Placebo comparator | Biological: lerodalcibep 300 mg Monthly SCSC QM |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Provision of written and signed informed consent/assent prior to any study-specific procedure;
- Male or female, 6 to 17 years of age (defined as from 6 to less than 18 years of age), at the first Screening Visit;
- Weight of more than 18 kg (40 lbs) and BMI more than 17 and less than42 kg/m2;
- Diagnosis of definite, probable, or possible HeFH based on clinical criteria (SB Register criteria or genotyping and at the defined eligibility visit (Screening Visit or post washout/stabilization); a calculated LDL-C (Friedewald) equal or above 130 mg/dL and TG below 400 mg/dL while on stable lipid-lowering oral drug therapy (eg, maximally tolerated statin with or without ezetimibe); Note: Patients unable to tolerate approved doses of a statin may take lower than approved doses and less frequently than daily as long as the dose and dosing frequency is consistent per the Investigator's judgment. Patients with documented intolerance to statins may also participate;
- On a stable diet and lipid-lowering oral therapies (statins, ezetimibe, bile-acid sequestrants) or combinations thereof for at least 6 weeks (excluded oral lipid-lowering agents include mipomersen, lomitapide, and gemfibrozil);
Key exclusion criteria (22 listed)
- Use of prohibited oral lipid-lowering agents mipomersen or lomitapide within 6 months of screening or gemfibrozil within 6 weeks of the Screening Visit;
- LDL or plasma apheresis within 2 months prior to Day 1;
- Documented history of HoFH defined as clinical and/or genetic with true HoFH (ie, identical pathogenic variants), compound heterozygous (ie, 2 different pathogenic LDLR variants) or combined heterozygous (2 different pathogenic FH variants such as LDLR plus ApoB or LDLR plus PCSK9 gain-of function);
- History of any prior or active clinical condition or acute and/or unstable systemic disease compromising patient inclusion, at the discretion of the Investigator, including but not limited to clinically significant pulmonary, hematologic, gastrointestinal, endocrine (excluding diabetes), immunologic, dermatologic, neurologic, or psychiatric disease, which in the Investigator's opinion, would not be suitable for the study from a patient safety consideration or could interfere with the results of the study;
- Females of childbearing potential who are sexually active, not using or unwilling to use a highly effective form of contraception, pregnant or breastfeeding, or who have a positive urine pregnancy test at the last Screening Visit; Note: Highly effective methods of birth control include refraining from heterosexual sexual intercourse during the entire period of risk, birth control pills or patches, IUDs, sexual activity with a male partner who has had a vasectomy, condom or diaphragm or cervical cap with spermicide or IUD, oral, implantable, or injectable contraceptives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lerodalcibep 300 mg Monthly SCAlso: placebo monthly SClerodalcibep or placebo | Biological | Lerodalcibep, Placebo |
Primary outcome
Low Density Lipoprotein cholesterol at week 12
Time frame: Week 12
Change in LDL-C at week 12 relative to that of placebo
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Kallend, MB BS study director
Chief Medical Officer, LIB Therapeutics, LLC
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lerodalcibep 300 mg Monthly SC in people with Familial Hypercholesterolemia - Heterozygous, run by LIB Therapeutics LLC at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Africa, United States, Israel, New Zealand, Norway and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Density Lipoprotein cholesterol at week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.