NCT07050160

Brief Summary

The primary objective of this Phase 1/2 long-term follow-up (LTFU) study is to assess the long-term safety and tolerability of LX2020 for the treatment of arrhythmogenic cardiomyopathy (ACM) due to a plakophilin-2 gene (PKP2) pathogenic variant (PKP2-ACM).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
52mo left

Started Aug 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Aug 2025Aug 2030

First Submitted

Initial submission to the registry

June 11, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 29, 2025

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2030

Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

4.9 years

First QC Date

June 11, 2025

Last Update Submit

November 10, 2025

Conditions

Arrhythmogenic CardiomyopathyPKP2-ACMPKP2-ARVC

Keywords

Arrhythmogenic CardiomyopathyACMCardiomyopathyARVCArrhythmogenic Right VentricularArrhythmogenic Right Ventricular DysplasiaGenetic cardiomyopathyGene TherapyPKP2 GenePlakophilin-2LX2020GRIT-PKP2Ventricular ArrhythmiaPVCsSudden Cardiac DeathCardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects who experienced at least 1 treatment emergent adverse event (TEAE) and/or 1 treatment emergent serious adverse event (TESAE).

    Evaluation of Safety and Tolerability of LX2020

    4 years

Other Outcomes (1)

  • Selected Exploratory

    4 years

Study Arms (1)

LX2020 treated participants

Participants who received LX2020 in Study LX2020-01

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants who received LX2020 in Study LX2020-01 will roll over into this study.

You may qualify if:

  • Participants who received LX2020 in study LX2020-01

You may not qualify if:

  • Concurrent enrollment in any other clinical investigation involving use of an investigational agent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

CardiomyopathiesArrhythmogenic Right Ventricular DysplasiaDeath, Sudden, CardiacHeart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lexeo Clinical Trials

    Lexeo Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2025

First Posted

July 3, 2025

Study Start

August 29, 2025

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2030

Last Updated

November 12, 2025

Record last verified: 2025-11

Locations

US(1)