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RecruitingPhase 1/Phase 2

ALXN2350 in Adult Participants With BAG3-Associated Dilated Cardiomyopathy

Alexion Pharmaceuticals, Inc. · NCT07218887

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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 18–70 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
6
US sites recruiting
7
Study start
October 24, 2025
Record last updated
August 28, 2026

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

What the study is about

This Phase 1/2 study is an open-label, dose finding and dose expansion study investigating the safety, tolerability, and efficacy of a single IV infusion of ALXN2350 in adult participants with BAG3 associated DCM.

Being studied: ALXN2350

Conditions: BAG3 Mutation Associated Dilated Cardiomyopathy

Eligibility criteria

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

Show full criteria

Inclusion Criteria

  • Pathogenic or likely pathogenic mutation in BAG3
  • Medical history of diagnosis of DCM
  • Stable combination of HF SoC medications
  • Adequate acoustic windows for echocardiography
  • LVEF > 15% and ≤ 45% at Screening by echocardiography
  • Diagnosis of chronic HF for at least 3 months
  • NYHA Class I/II/III at Screening

Exclusion Criteria

  • Presence of antibodies to AAV9
  • Presence of a pathogenic or likely pathogenic variant in another gene where that other gene is authoritatively recognized as causal for DCM
  • Decompensated HF
  • Cardiac ventricular arrhythmia that requires treatment
  • History of untreated clinically significant valve disease or a Screening confirmation of severe aortic stenosis, severe mitral stenosis, moderate or severe aortic insufficiency or severe mitral insufficiency
  • NYHA Class IV
  • History of substance abuse that could contribute to cardiac dysfunction

Note: Other inclusion and exclusion criteria may apply.

Recruiting US locations

  • Research Site

    Birmingham, AL 35233

    Site contact: Nehal Vekariya · 205-934-7173 · nvekariya@uabmc.edu

  • Research Site

    Palo Alto, CA 94304

    Site contact: Shannon Schultz · 650-498-9617 · sks01@stanford.edu

  • Research Site

    Boston, MA 02115

    Site contact: Alyx Vogle · 617-732-6320 · avogle@bwh.harvard.edu

  • Research Site

    Cincinnati, OH 45219

    Site contact: Sara Black · 513-585-1777 · sara.black@thechristhospital.com

  • Research Site

    Portland, OR 97239-3098

    Site contact: Hailey Volk · 503-418-2246 · volkh@ohsu.edu

  • Research Site

    Philadelphia, PA 19104

    Site contact: Joseph Puhl · 267-399-3049 · joseph.puhl@pennmedicine.upenn.edu

  • Research Site

    Houston, TX 77030

    Site contact: Jennifer Garrett · 346-238-4516

Study contacts (from the official record)

  • Alexion Pharmaceuticals, Inc. (Sponsor) · 1-855-752-2356 · clinicaltrials@alexion.com
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ALXN2350 in Adult Participants With BAG3-Associated Dilated… (NCT07218887) | Bored Studies