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RecruitingPhase 2

Study of LX2006 Gene Therapy in Friedreich Ataxia Cardiomyopathy

Lexeo Therapeutics · NCT07721025

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 6+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
26
US sites recruiting
1
Study start
June 25, 2026
Record last updated
September 2, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The purpose of Study LX2006-03, a multicenter, Phase 2, open-label, randomized, controlled study, is to evaluate the efficacy and safety of LX2006 gene therapy in participants with Friedreich ataxia (FA) cardiomyopathy (CM).

Being studied: LX2006; Usual Care

Conditions: Friedreich Ataxia; Cardiomyopathy, Secondary

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Male or female, age at least 6 years at the time of signing the informed consent (and assent, if applicable).
  • Diagnosis of FA, based on clinical phenotype and genotype (GAA expansion on the frataxin gene)
  • Onset of FA on or before 25 years of age
  • Confirmed left ventricular hypertrophy and abnormal left ventricular mass index
  • Left ventricular ejection fraction at least 30%
  • Anti-AAVrh.10 total antibody titer less than the protocol-specified maximum level

Exclusion Criteria

  • Presence of other forms of cardiomyopathy that contribute to heart failure
  • Current use of inotrope infusion or presence of a ventricular assist device
  • Contraindication to cardiac MRI
  • Prior organ transplant
  • Previous gene transfer or cell therapy
  • Poorly controlled diabetes (hemoglobin A1c ≥8%)
  • Active hematologic or solid organ cancer

Other inclusion/exclusion criteria to be applied as per protocol.

Recruiting US locations

  • University of South Florida

    Tampa, FL 33612

    Site contact: Lucretia Campbell · 813-974-5633 · lcampbel@usf.edu

Study contacts (from the official record)

  • Lexeo Clinical Trials · 212-547-9879 · clinicaltrials@lexeotx.com
All heart & blood pressure studies in Florida →
Study of LX2006 Gene Therapy in Friedreich Ataxia Cardiomyopathy (NCT07721025) | Bored Studies