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

Conditions

• Familial Hypercholesterolemia - Heterozygous

Eligibility Criteria

Sex

ALL

Age

6 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• lerodalcibep 300 mg Monthly SC — BIOLOGICAL
  lerodalcibep or placebo

Study Details

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.

Key Dates

Start date

Sep 1, 2025

Status verified

Jul 2025

Primary completion

Dec 31, 2026

Completion

Jun 30, 2027

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm 1: lerodalcibep 300 mg
  monthly Subcutaneous injection
• Placebo Comparator: Arm 2: Placebo
  monthly subcutaneous injection

Primary Outcome Measure

Low Density Lipoprotein cholesterol at week 12 [ Time Frame: Week 12 ]

Central Contacts

• Kate Caldwell Sr. Director, Clinical Development, LIB Therapeutics, LLC, BS MT(ASCP)
  800-345-2032
  [email protected]

Locations (1)

Find similar trials in Cincinnati, OH

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