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A Study of the Safety and Efficacy of Prime Editing (PM577) in Participants With Wilson Disease (WD)

Study acronym: PM577a
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Study sites: 3 to 4
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 5 of 19 entries
  2. Site details revised at 1 of 3 sitesv6
  3. Study sites: 2 to 3v5
  4. Recruitment opened
    • Start date pushed from Aug 2026 to Sep 2026
    • Study sites: 1 to 2
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  6. Site contact updatedv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to evaluate the safety, tolerability, biological activity, and initial efficacy of PM577a, an investigational Prime Editing therapy, in adults and adolescents with Wilson disease (WD). Wilson disease is caused by changes (mutations) in the ATP7B gene that prevent the body from removing excess copper normally. PM577a is designed to precisely correct one of the most common disease-causing ATP7B mutations (p.H1069Q) in liver cells with the goal of restoring normal copper metabolism. This is the first study of PM577a in people. Participants will receive a single intravenous (IV) infusion of PM577a and will be monitored closely to evaluate safety, how the body responds to treatment, whether copper metabolism improves, and whether treatment may improve signs and symptoms of Wilson disease.
Trial Details
NCT Number NCT07748403
Lead Sponsor Prime Medicine, Inc.
Conditions
(from sponsor)		 Wilson Disease, Wilson's Disease, Wilsons Disease
Related terms Hepatolenticular Degeneration
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov