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Open-label, Phase 1b, Single-ascending Dose and Optional Re Dosing Study to Evaluate the Safety of VERVE-101 Administered to Patients with Heterozygous Familial Hypercholesterolemia, Atherosclerotic Cardiovascular Disease, and Uncontrolled Hypercholesterolemia

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Trial Profile

Open-label, Phase 1b, Single-ascending Dose and Optional Re Dosing Study to Evaluate the Safety of VERVE-101 Administered to Patients with Heterozygous Familial Hypercholesterolemia, Atherosclerotic Cardiovascular Disease, and Uncontrolled Hypercholesterolemia

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 06 Jan 2025

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At a glance

  • Drugs VERVE-101 (Primary)
  • Indications Hypercholesterolaemia; Hyperlipoproteinaemia type II
  • Focus Adverse reactions; First in man; Proof of concept
  • Acronyms Heart-1
  • Sponsors Verve Therapeutics

    • Most Recent Events

    • 30 Dec 2024 Planned End Date changed from 1 Dec 2024 to 1 Jun 2025.
    • 30 Dec 2024 Planned primary completion date changed from 1 Dec 2024 to 1 Jun 2025.
    • 09 Oct 2024 According to a Verve Therapeutics media release, as per updates on PCSK9 program the Heart-1 clinical trial would be halted due to an adverse event in an individual who had been dosed at 0.45 mg/kg of VERVE-101, and that the LNP delivery system was to blame.

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