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NOT YET RECRUITING
NCT07775339
PHASE3

Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents With Familial Hypercholesterolemia

Sponsor: LIB Therapeutics LLC

View on ClinicalTrials.gov

Summary

The goal is to assess the long term efficacy (LDL cholesterol reduction) and safety over 3 years of lerodalcibep (Lerochol) SC 300 mg QM administered by auto-injector (AI)/pre-filled pen (PFP) 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 who completed the 24 week placebo controlled base trial. The main question\[s\] it aims to answer are: How effective is Lerochol in maintaining LDL cholesterol reductions over years? How well is it tolerated and are there any safety concerns? Participants will visit the clinic every month for 3 months and then home dosed with clinic visits every 3 months. They will undergo periodic 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.

Official title: Open Label Phase 3b Study to Evaluate the Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents, 6 to 17 Years of Age, With Heterozygous Familial Hypercholesterolemia (LIBerate-Kids OLE)

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2027-01-20

Completion Date

2031-12-31

Last Updated

2026-08-25

Healthy Volunteers

No

Interventions

DRUG

Lerodalcibep

300 mg monthly

Locations (5)

G.B. Pant Institute of Postgraduate Medical Education & Research

Delhi, India

Haddassah Medical Center

Jerusalem, Israel

New Zealand Clinical Research

Christchurch, New Zealand

Iatros International

Bloemfontein, Oranage Free State, South Africa

Ege Universitesi Tip Fakultesi

Izmir, Turkey (Türkiye)